Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 11:28 AM
Study NCT ID:
NCT02942160
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003012', 'term': 'Microbial Collagenase'}], 'ancestors': [{'id': 'D017364', 'term': 'Collagenases'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials@Endo.com', 'phone': '800-462-3636', 'title': 'Saji Vijayan, MBBS', 'organization': 'Endo Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)', 'description': 'All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.\n\nOne death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.', 'eventGroups': [{'id': 'EG000', 'title': 'Observation Phase', 'description': 'Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 0, 'seriousNumAtRisk': 259, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'EN3835 Treatment Phase', 'description': 'Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 176, 'seriousNumAtRisk': 200, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 170}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 113}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Injection site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Upper respiratory tract infection', 'notes': 'No AEs occurred at a frequency greater than or equal to 5% in Observation Phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Spontaneous Miscarriage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypertensive Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Death from Motor Vehicle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Observation Visit Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180 to Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit.\n\nObservation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Durability Population for Double-blind Treated Participants is defined as all participants in the Overall Durability Population for both who showed an improvement on Day 71 of at least 2-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Observation Durability Visit Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Observation Durability Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180 to Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Durability Population for Double-blind Treated Participants is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Long-term Durability Visit Day 540', 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Long-term Durability Visit Day 720', 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 540 to Day 720', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Durability Population for Double-blind Treated Participants, defined as all participants who showed an improvement on Day 71 of at least 2-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201), and had an Observation at Day 540.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Long-term Durability Visit Day 540', 'categories': [{'title': 'Yes', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Long-term Durability Visit Day 720', 'categories': [{'title': 'Yes', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 540 to Day 720', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Durability Population for Double-blind Treated Participants, defined as all participants who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201), and had an Observation at Day 540.'}, {'type': 'SECONDARY', 'title': 'CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 0.84 mg', 'description': 'Treatment in Study EN3835-201'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in Study EN3835-201'}], 'classes': [{'title': 'Change from Baseline on Day 71 (EN3835-201 Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline-Observation Visit Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline-Observation Visit Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline-Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (in EN3835-201 Study) to Observation Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).'}, {'type': 'SECONDARY', 'title': 'CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Change from Baseline (BL) to Treatment Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline (BL) to Treatment Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline (BL) to Treatment Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Treatment Observation Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Treatment Observation Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 22 to Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.'}, {'type': 'SECONDARY', 'title': 'PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Change from Baseline (BL) to Treatment Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline (BL) to Treatment Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline (BL) to Treatment Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Treatment Observation Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Treatment Observation Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 22 to Day 360', 'description': 'Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Hexsel CSS Total Score During the Observation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 0.84 mg', 'description': 'Treatment in Study EN3835-201'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in Study EN3835-201'}], 'classes': [{'title': 'Baseline Point (in EN3835-201 Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 71 Reference Point (in EN3835 Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline (Day 71)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.81', 'groupId': 'OG001'}]}]}, {'title': 'Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline (Day 360)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (in EN3835-201 Study) to Day 360', 'description': 'The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Baseline (in EN3835-201 Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '1.43', 'groupId': 'OG000'}]}]}, {'title': 'Long-term Durability Visit Day 540-Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'Long-term Durability Visit Day 720-Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 540 to Day 720', 'description': 'The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. A negative change from baseline indicates an improvement in cellulite severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Durability Population in Double-blind Treated Participants is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Second EN3835 Treatment: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'Second EN3835 Treatment: Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '2.41', 'groupId': 'OG000'}]}]}, {'title': 'Second EN3835 Treatment: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.32', 'groupId': 'OG000'}]}]}, {'title': 'Second EN3835: Treatment Observation Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': 'Second EN3835: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - Day 360', 'description': 'The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3". The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. Change from baseline is the visit total score minus baseline total score. A negative change from baseline indicates an improvement in cellulite severity.\n\nTreatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in the current study.'}, {'type': 'SECONDARY', 'title': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 0.84 mg', 'description': 'Treatment in Study EN3835-201'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in Study EN3835-201'}], 'classes': [{'title': 'Very Much Improved (3)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Much Improved (2)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Improved (1)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'No Change (0)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Worse (-1)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Much Worse (-2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Very Much Worse (-3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 360', 'description': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).'}, {'type': 'SECONDARY', 'title': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Second EN3835 Treatment: Treatment Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Much Improved (3)', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Much Improved (2)', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Improved (1)', 'measurements': [{'value': '73', 'groupId': 'OG000'}]}, {'title': 'No Change (0)', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Worse (-1)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Much Worse (-2)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse (-3)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Second EN3835 Tx: Treatment Observation Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Much Improved (3)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Much Improved (2)', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Improved (1)', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': 'No Change (0)', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Worse (-1)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Much Worse (-2)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse (-3)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 71 - Day 360', 'description': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment course in Study EN3835-202.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in the current study.'}, {'type': 'SECONDARY', 'title': 'Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 0.84 mg', 'description': 'Treatment in Study EN3835-201'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in Study EN3835-201'}], 'classes': [{'categories': [{'title': 'Very Much Improved (3)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Much Improved (2)', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Improved (1)', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'No Change (0)', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Worse (-1)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Much Worse (-2)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very Much Worse (-3)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 360', 'description': 'Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in S-GAIS indicates an improvement. Percentages are based on the number of all evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201'}, {'type': 'SECONDARY', 'title': 'Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Second EN3835 Treatment: Treatment Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Much Improved (3)', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Much Improved (2)', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Improved (1)', 'measurements': [{'value': '69', 'groupId': 'OG000'}]}, {'title': 'No Change (0)', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Worse (-1)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Much Worse (-2)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse (-3)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Second EN3835 Tx: Treatment Observation Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Much Improved (3)', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Much Improved (2)', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Improved (1)', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': 'No Change (0)', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Worse (-1)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Much Worse (-2)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse (-3)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 71 - Day 360', 'description': 'Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in EN3835-202 Study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 0.84 mg', 'description': 'Treatment in Study EN3835-201'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in Study EN3835-201'}], 'classes': [{'categories': [{'title': 'Very Satisfied with Treatment (2)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Satisfied with Treatment (1)', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Neither Dissatisfied nor Satisfied with Tretmt (0)', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Dissatisfied with Treatment (-1)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Very Dissatisfied with Treatment (-2)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 360', 'description': 'Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. (EFP = Edematous Fibrosclerotic Panniculopathy, aka Cellulite)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Second EN3835 Treatment: Treatment Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied wth Treatment (2)', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'Satisfied with Treatment (1)', 'measurements': [{'value': '67', 'groupId': 'OG000'}]}, {'title': 'Neither Dissatisfied nor Satisfied with Tx (0)', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Dissatisfied with Treatment (-1)', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied with Treatment (-2)', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Second EN3835 Treatment: Treatment Obsv Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied wth Treatment (2)', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Satisfied with Treatment (1)', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}, {'title': 'Neither Dissatisfied nor Satisfied with Tx (0)', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Dissatisfied with Treatment (-1)', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied with Treatment (-2)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 71 - Day 360', 'description': 'Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Serum Antibody at Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 0.84 mg', 'description': 'Treatment in Study EN3835-201'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in Study EN3835-201'}], 'classes': [{'title': 'anti-AUX-I: Observation Visit Day 360', 'categories': [{'title': 'Seropositive', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Seronegative', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'anti-AUX-II: Observation Visit Day 360', 'categories': [{'title': 'Seropositive', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Seronegative', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 360', 'description': 'Percent of participants that are seropositive. Descriptive statistics are based on log10 transformation of titer levels. Percent is based on the number of subjects who had immunogenicity lab samples drawn at the visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201 (259 participants in Observation Phase). Included all participants with collected samples at Day 360.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Antibody Log Titer Levels at Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 0.84 mg', 'description': 'Treatment in Study EN3835-201'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in Study EN3835-201'}], 'classes': [{'title': 'anti-AUX-I: Observation Visit Day 360 positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.085', 'spread': '1.192', 'groupId': 'OG000'}, {'value': '2.576', 'spread': '0.213', 'groupId': 'OG001'}]}]}, {'title': 'anti-AUX-II: Observation Visit Day 360 positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.175', 'spread': '1.239', 'groupId': 'OG000'}, {'value': '1.547', 'spread': '0.315', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 360', 'description': 'Descriptive statistics are based on log10 transformation of titer levels.', 'unitOfMeasure': 'log 10 titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase). Included Seropositive participants at Day 360.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neutralizing Antibodies at Observation Visit Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Neutralizing AUX-I Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Neutralizing AUX-II Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 360', 'description': 'Participants with binding antibodies were tested for neutralizing antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observation Population included all participants who rolled over from Study EN3835-201 (259 participants in Observation Phase).Included Seropositive participants at Day 360.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'anti-AUX-I: Treatment Day 1 positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.038', 'spread': '0.697', 'groupId': 'OG000'}]}]}, {'title': 'anti-AUX-I: Treatment Day 71 positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.268', 'spread': '0.786', 'groupId': 'OG000'}]}]}, {'title': 'anti-AUX-I: Treatment Observation Day 360 positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.964', 'spread': '0.584', 'groupId': 'OG000'}]}]}, {'title': 'anti-AUX-II: Treatment Day 1 positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.853', 'spread': '0.854', 'groupId': 'OG000'}]}]}, {'title': 'anti-AUX-II: Treatment Day 71 positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.832', 'spread': '0.736', 'groupId': 'OG000'}]}]}, {'title': 'anti-AUX-II: Treatment Observation Day 360 positiv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.714', 'spread': '0.635', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 360', 'description': 'Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels.', 'unitOfMeasure': 'Log 10 titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included participants with seropositive antibody results'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttocks \\& Thighs Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum'}], 'classes': [{'title': 'Treatment Day 71: Neutralizing AUX-I Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Day 71: Neutralizing AUX-II Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Tx Obs Day 360: Neutralizing AUX-I Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Tx Obs Day 360: Neutralizing AUX-II Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Positive', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 71 to Day 360', 'description': 'Tx Obs = Treatment Observation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included participants with observed antibody levels at Day 71 in Q1 and Q4'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EN3835 Treated Participants in EN3835-202', 'description': 'Observation Phase (259 Started \\& 222 Completed):\n\nObservation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201\n\nEN3835 Treated Participants in EN3835-202:\n\nButtock \\& Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Observation Phase prior to open-label treatment phase', 'groupId': 'FG000', 'numSubjects': '259'}]}, {'type': 'EN3835-202 Participants', 'achievements': [{'comment': 'Observation Phase Completed', 'groupId': 'FG000', 'numSubjects': '222'}]}, {'type': 'EN3835 Treated Subjects in EN3835-202', 'achievements': [{'comment': 'EN3835 Treated Participants in EN3835-202 Started', 'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'EN3835 Treated Participants in EN3835-202 Completed', 'groupId': 'FG000', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'EN3835 Treatment Regions', 'description': 'Buttock \\& Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '11.06', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '200', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '154', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '173', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '6.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-02', 'size': 27445850, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-05T15:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2019-06-12', 'completionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2016-10-20', 'dispFirstSubmitQcDate': '2019-06-12', 'resultsFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2016-10-20', 'dispFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-02', 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Serum Antibody at Observation Visit Day 360', 'timeFrame': 'Day 360', 'description': 'Percent of participants that are seropositive. Descriptive statistics are based on log10 transformation of titer levels. Percent is based on the number of subjects who had immunogenicity lab samples drawn at the visit'}, {'measure': 'Overall Antibody Log Titer Levels at Observation Visit Day 360', 'timeFrame': 'Day 360', 'description': 'Descriptive statistics are based on log10 transformation of titer levels.'}, {'measure': 'Neutralizing Antibodies at Observation Visit Day 360', 'timeFrame': 'Day 360', 'description': 'Participants with binding antibodies were tested for neutralizing antibodies.'}, {'measure': 'Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment', 'timeFrame': 'Day 1 to Day 360', 'description': 'Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels.'}, {'measure': 'Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment', 'timeFrame': 'Day 71 to Day 360', 'description': 'Tx Obs = Treatment Observation'}], 'primaryOutcomes': [{'measure': 'Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase', 'timeFrame': 'Day 180 to Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit.\n\nObservation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase', 'timeFrame': 'Day 180 to Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.'}, {'measure': 'Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase', 'timeFrame': 'Day 540 to Day 720', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).'}, {'measure': 'Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase', 'timeFrame': 'Day 540 to Day 720', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).'}, {'measure': 'CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase', 'timeFrame': 'Baseline (in EN3835-201 Study) to Observation Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.'}, {'measure': 'CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment', 'timeFrame': 'Day 22 to Day 360', 'description': 'Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.'}, {'measure': 'PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment', 'timeFrame': 'Day 22 to Day 360', 'description': 'Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.'}, {'measure': 'Change From Baseline on the Hexsel CSS Total Score During the Observation Phase', 'timeFrame': 'Baseline (in EN3835-201 Study) to Day 360', 'description': 'The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score.'}, {'measure': 'Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits', 'timeFrame': 'Day 540 to Day 720', 'description': 'The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. A negative change from baseline indicates an improvement in cellulite severity.'}, {'measure': 'Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment', 'timeFrame': 'Baseline - Day 360', 'description': 'The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3". The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. Change from baseline is the visit total score minus baseline total score. A negative change from baseline indicates an improvement in cellulite severity.\n\nTreatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202.'}, {'measure': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase', 'timeFrame': 'Day 360', 'description': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.'}, {'measure': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment', 'timeFrame': 'Day 71 - Day 360', 'description': 'Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment course in Study EN3835-202.'}, {'measure': 'Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360', 'timeFrame': 'Day 360', 'description': 'Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in S-GAIS indicates an improvement. Percentages are based on the number of all evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.'}, {'measure': 'Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment', 'timeFrame': 'Day 71 - Day 360', 'description': 'Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in EN3835-202 Study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.'}, {'measure': 'Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360', 'timeFrame': 'Day 360', 'description': 'Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. (EFP = Edematous Fibrosclerotic Panniculopathy, aka Cellulite)'}, {'measure': 'Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment', 'timeFrame': 'Day 71 - Day 360', 'description': 'Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from "+2" (I am very satisfied with the cellulite treatment on my buttocks or thighs) to "-2" (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Edematous Fibrosclerotic Panniculopathy', 'Cellulite']}, 'descriptionModule': {'briefSummary': 'A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Observation Phase:\n\n* Voluntarily sign and date an informed consent agreement\n* Have participated in and completed the double-blind study EN3835-201\n* Be willing to apply sunscreen to any treated quadrant before each exposure to sun\n\nInclusion Criteria for Treatment Phase:\n\n* Voluntarily sign and date an informed consent agreement\n* Have participated in and completed the double-blind study EN3835-201\n* Be willing to apply sunscreen to any treated quadrant before each exposure to sun\n* Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13\n* Be judged to be in good health\n* Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal\n\nExclusion Criteria for Observation Phase:\n\n* None\n\nExclusion Criteria for Treatment Phase:\n\n* Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks\n* Is presently nursing a baby or providing breast milk for a baby\n* Intends to become pregnant during the study\n* Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication\n* History of stroke or bleeding'}, 'identificationModule': {'nctId': 'NCT02942160', 'briefTitle': 'EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy', 'orgStudyIdInfo': {'id': 'EN3835-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EN3835 Active', 'description': 'EN3835 0.84mg (Collagenase Clostridium Histolyticum)', 'interventionNames': ['Biological: Collagenase Clostridium Histolyticum']}], 'interventions': [{'name': 'Collagenase Clostridium Histolyticum', 'type': 'BIOLOGICAL', 'otherNames': ['Xiaflex'], 'armGroupLabels': ['EN3835 Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #1', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92562', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #2', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #3', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #4', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #5', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #6', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33401', 'city': 'Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #7', 'geoPoint': {'lat': 26.70562, 'lon': -80.03643}}, {'zip': '63091', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #8', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #10', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #9', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #11', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #12', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #13', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #14', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #15', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Mike McLane', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}