Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT04466527
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-16
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Treatment of Moderate to Severe Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in Physician's Global Assessment (PGA) of Acne Severity", 'timeFrame': 'Change in PGA score between baseline visit and post procedural visit', 'description': "The physician will score the acne vulgaris based on the Physician's Global Assessment (PGA) scale. A score of 0 indicates that residual hyperpigmentation and erythema may be present; a score of 1 indicates that there are a few scattered comedones and a few small papules; a score of 3 indicates that more than half of the face is involved, that there are many comedones, papules, and pustules, and that one nodule may be present; a score of 4 indicates that the entire face is involved, covered with comedones, numerous papules and pustules, and a few nodules and cysts. The change in PGA score will be recorded at each of the 4 study visits, for up to"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Acne', 'Acne Vulgaris', 'Laser', 'Cystic Acne'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'In this study, we are enrolling subjects with moderate to severe acne vulgaris and investigating the use of a commercially available laser in treating acne.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;\n2. In good general health, based on answers provided during the screening visit;\n3. Subject must be able to read and understand English;\n4. Any gender and any Fitzpatrick skin type;\n5. Ages 18 through 40;\n6. Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4)\n7. Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment;\n8. Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy).\n\nExclusion Criteria:\n\n1. Participation in another investigational drug or device clinical trial in the past 30 days;\n2. Currently undergoing or wish to begin or continue topical treatments;\n3. Are pregnant or lactating;\n4. History of allergic reaction to topical anesthesia;\n5. Subjects may not have undergone oral isotretinoin therapy within the past 12 months;\n6. Currently take oral antibiotic or oral therapy for acne;\n7. History of keloidal or hypertrophic scarring;\n8. Laser treatment in past six months;\n9. History of poor wound healing;\n10. Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.'}, 'identificationModule': {'nctId': 'NCT04466527', 'briefTitle': 'Laser Treatment of Moderate to Severe Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial', 'orgStudyIdInfo': {'id': '2020P000838'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control.', 'interventionNames': ['Device: Laser Intervention']}], 'interventions': [{'name': 'Laser Intervention', 'type': 'DEVICE', 'description': 'Subjects with undergo laser exposure of their active acne vulgaris.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH Clinical Unit for Research Trials & Outcomes in Skin', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Dieter Manstein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dieter Manstein, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}