Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-24 @ 11:09 PM
Study NCT ID:
NCT01320033
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Studies@galderma.com', 'phone': '817 961 5000', 'title': 'Clinical Operations', 'phoneExt': '+1', 'organization': 'Galderma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline up to Week 16', 'eventGroups': [{'id': 'EG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 29, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 51, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 29, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Multiple drug overdose intentional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 222, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.1', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '14.60', 'groupId': 'OG001'}, {'value': '-12.6', 'spread': '16.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '-1.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '-0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.595', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '1.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat (ITT) population consisted of all participants who were randomized and to whom study drug was dispensed.'}, {'type': 'SECONDARY', 'title': 'Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16 (LOCF)', 'description': 'IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules \\[inflammatory lesions\\]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions \\[papules/pustules only; no nodulo-cystic lesions\\]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population consisted of all participants who were randomized and to whom study drug was dispensed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.6', 'spread': '31.72', 'groupId': 'OG000'}, {'value': '-40.3', 'spread': '40.90', 'groupId': 'OG001'}, {'value': '-37.1', 'spread': '44.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants who were randomized and to whom study drug was dispensed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.3', 'spread': '32.24', 'groupId': 'OG000'}, {'value': '-27.8', 'spread': '43.94', 'groupId': 'OG001'}, {'value': '-27.8', 'spread': '38.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants who were randomized and to whom study drug was dispensed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '21.49', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '21.60', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '18.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). Change from baseline in non-inflammatory lesion counts to week 16 were reported', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants who were randomized and to whom study drug was dispensed.'}, {'type': 'SECONDARY', 'title': 'Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'classes': [{'title': 'Baseline : Lesion of Truncal Acne on Back', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.07', 'groupId': 'OG002'}]}]}, {'title': 'Baseline : Lesion of Truncal Acne on Chest', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 : Lesions of Truncal Acne on Back', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.04', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 : Lesion of Truncal Acne on Chest', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.95', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 : Lesions of Truncal Acne on Back', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.03', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 : Lesion of Truncal Acne on Chest', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, and Week 16', 'description': 'Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all participants who were randomized and to whom study drug was dispensed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 16', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population consisted of all participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 milligrams (mg) of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'FG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '224'}, {'groupId': 'FG002', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '160'}, {'groupId': 'FG002', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted in United States between 29 March 2011 (first participant first visit) to 3 January 2012 (last participant last visit).', 'preAssignmentDetails': 'A total of 662 participants randomized the study and dispensed with study drug out of which 487 completed study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '662', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CD2475/101 40 mg', 'description': 'Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'BG001', 'title': 'Doxycycline 100 mg', 'description': 'Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '388', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '274', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'spread': '7.70', 'groupId': 'BG000'}, {'value': '19.6', 'spread': '7.54', 'groupId': 'BG001'}, {'value': '18.7', 'spread': '6.34', 'groupId': 'BG002'}, {'value': '19.3', 'spread': '7.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '351', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '560', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '492', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '662', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-treat (ITT) Population consisted of all participants who were randomized and to whom study drug was dispensed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 662}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2012-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2011-03-21', 'resultsFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-06', 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.'}], 'secondaryOutcomes': [{'measure': 'Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'Week 16 (LOCF)', 'description': 'IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules \\[inflammatory lesions\\]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions \\[papules/pustules only; no nodulo-cystic lesions\\]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF).'}, {'measure': 'Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.'}, {'measure': 'Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported.'}, {'measure': 'Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From Baseline up to Week 16 (LOCF)', 'description': 'The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). Change from baseline in non-inflammatory lesion counts to week 16 were reported'}, {'measure': 'Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16', 'timeFrame': 'Baseline, Week 12, and Week 16', 'description': 'Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions.'}, {'measure': 'Number of Participants With at Least One Adverse Event (AE)', 'timeFrame': 'From Baseline up to Week 16', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acne vulgaris', 'inflammatory lesions'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.', 'detailedDescription': "Investigator's global assessment and lesion count will be performed at each study visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects 12 years of age or older\n* acne vulgaris with facial involvement\n* A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory)\n* 25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)\n\nExclusion Criteria:\n\n* More than two acne nodules/cysts on the face\n* Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment\n* Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea\n* Beard or facial hair which might interfere with study assessments\n* planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp)\n* Use of oral contraceptives solely for control of acne\n* Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5 times above upper limit of normal\n* Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher\n* Presence of oral or genital candidiasis or history of multiple episodes of oral or genital candidiasis\n* Females who intend to conceive a child within 5 months following Baseline visit\n* Males who intend to conceive a child with partner during the study period\n* Requiring concomitant use of methoxyflurane"}, 'identificationModule': {'nctId': 'NCT01320033', 'briefTitle': 'Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multi Center, Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group Study Comparing the Efficacy and Safety of CD2475/101 40 mg Tablets Versus Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions in Subjects With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD2475/101 40 mg', 'description': 'Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.', 'interventionNames': ['Drug: CD2475/101 40 mg', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline 100 mg', 'description': 'Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.', 'interventionNames': ['Drug: Doxycycline 100 mg', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CD2475/101 40 mg', 'type': 'DRUG', 'description': 'Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.', 'armGroupLabels': ['CD2475/101 40 mg']}, {'name': 'Doxycycline 100 mg', 'type': 'DRUG', 'description': 'Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks', 'armGroupLabels': ['Doxycycline 100 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.', 'armGroupLabels': ['CD2475/101 40 mg', 'Doxycycline 100 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Medical Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80501', 'city': 'Longmont', 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'United States', 'facility': 'PMG Research of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44118', 'city': 'South Euclid', 'state': 'Ohio', 'country': 'United States', 'facility': 'Haber Dermatology & cosmetic Surgery, Inc', 'geoPoint': {'lat': 41.52311, 'lon': -81.51846}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Central Sooner Research', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Dermatology & Research Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18201', 'city': 'Hazleton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Stephen Schleicher', 'geoPoint': {'lat': 40.95842, 'lon': -75.97465}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Clinical Trial Services, LLC', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Center for Dermatology', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Derm Research, Inc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J&S Studies', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Suzanne Bruce and associates P.A. The Center for skin Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Stephen Miller MD', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dermatology Research Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Michael Graeber, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}