Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-23 @ 2:52 PM
Study NCT ID:
NCT03392935
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ks@checkmateproductions.com', 'phone': '8015816465', 'title': 'Dr. Karen Stolman, Assistant Professor, Dermatology', 'organization': 'University of Utah Dermatology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to week 12.', 'eventGroups': [{'id': 'EG000', 'title': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.\n\n1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 37, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transient Erythema', 'notes': 'Transient expected redness at the site of laser applicaiton, resolving within 3 days of treatment without sequela.\n\n.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 87, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Edema', 'notes': 'Transient expected swelling at site of laser application, resolving within 3 days of treatment without sequela.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 87, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.\n\n1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.33', 'spread': '2.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'lesion', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.\n\n1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '1.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesion', 'denomUnitsSelected': 'lesion'}, {'type': 'SECONDARY', 'title': 'Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.\n\n1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.92', 'spread': '2.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.\n\n1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.\n\n1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '44', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'lesions'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.\n\n1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.'}], 'measures': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '43.8', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}, {'units': 'Lesions', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Lesions'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-17', 'size': 140488, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-24T17:00', 'hasProtocol': True}, {'date': '2018-08-22', 'size': 264729, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-28T12:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Outcome assessors are masked and will not know which photos are pre-treatment or follow-up visit 1, however, they do know that all subjects received treatment at some point. They will rate the dermatofibromas to determine efficacy. However, there is only one arm of this study. All patients are receiving the same treatment. Outcomes assessors are the only masked roles.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects will have their dermatofibromas treated with the laser at week 0, and week 4. Blinded outcome assessors will rate photos (pre-treatment and follow-up visit 1) to determine efficacy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2018-01-02', 'resultsFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-01', 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.', 'timeFrame': '12 weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture)."}], 'secondaryOutcomes': [{'measure': 'Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.', 'timeFrame': '12 Weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture)."}, {'measure': 'Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.', 'timeFrame': '12 Weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture)."}, {'measure': 'Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.', 'timeFrame': '12 weeks', 'description': "Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale.\n\nThe lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dermatofibroma of Skin']}, 'descriptionModule': {'briefSummary': 'This study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at each visit and rated by blinded reviewers after the study to determine efficacy.', 'detailedDescription': 'The main objective of this study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. A secondary objective of this study is to better understand the 1540 nanometer Erbium glass laser and its impact on the skin.\n\nThis is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then have 2 additional follow-up visits (no laser treatment at these visits). Photographs will be taken at each visit and photographs from pre-treatment and follow-up 1 (week 8) will rated by blinded reviewers after the study to determine efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female or male, age 18-65, have at least one dermatofibroma of the skin, on the trunk or extremities, diagnosed by dermatologist, dermatofibroma is either itchy, painful or unattractive to the patient.\n\nExclusion Criteria:\n\n* previous treatment to the dermatofibroma(s), pregnant or nursing women, diabetic, smoker, psoriasis, lupus or other autoimmune diseases, patient with a clear history of keloids or poor wound healing. This study will exclude dermatofibroma lesions on the face and genitals.'}, 'identificationModule': {'nctId': 'NCT03392935', 'briefTitle': 'Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas', 'orgStudyIdInfo': {'id': 'IRB_101842'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Subjects', 'description': 'All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.', 'interventionNames': ['Device: 1540 nanometer Erbium glass laser']}], 'interventions': [{'name': '1540 nanometer Erbium glass laser', 'type': 'DEVICE', 'description': 'Subjects will receive laser treatment by dermatologist at week 0 and week 4.', 'armGroupLabels': ['All Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Dermatology', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Karen Stolman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}