Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-01 @ 8:38 PM
Study NCT ID:
NCT04220502
Status:
WITHDRAWN
Last Update Posted:
2022-05-09
First Post:
2020-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563016', 'term': 'pseudofolliculitis barbae'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Single blinded study where investigator does not know what method of facial hair removal subjects have used'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparing an experimental to control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment', 'timeFrame': '12 weeks', 'description': 'Difference in the investigator assessment of lesions and irritation at baseline and 12 weeks, measured by investigator. The scale title is Investigator Global Assessment, the minimum value is 0, the maximum is 5. Higher scores mean worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Patient Global Assessment', 'timeFrame': '12 weeks', 'description': 'Difference in the investigator assessment of disease symptoms at baseline and 12 weeks, measured by patient. The scale title is Patient Global Assessment, the minimum value is 0, the maximum is 5. Higher scores mean worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pseudofolliculitis Barbae']}, 'referencesModule': {'references': [{'pmid': '23652888', 'type': 'BACKGROUND', 'citation': 'Daniel A, Gustafson CJ, Zupkosky PJ, Candido A, Kemp HR, Russell G, McMichael A. Shave frequency and regimen variation effects on the management of pseudofolliculitis barbae. J Drugs Dermatol. 2013 Apr;12(4):410-8.'}, {'pmid': '21916277', 'type': 'RESULT', 'citation': "Kindred C, Oresajo CO, Yatskayer M, Halder RM. Comparative evaluation of men's depilatory composition versus razor in black men. Cutis. 2011 Aug;88(2):98-103."}]}, 'descriptionModule': {'briefSummary': 'Comparing the amount of papules, macules, pustules, and irritation caused by pseudofolluculitis barbae in subjects using depilatory cream versus traditional shaving methods.', 'detailedDescription': 'Comparing an experimental group that will remove facial hair with magic shave powder gold, and a control group that will continue using traditional shaving methods. Both the subject and a physician will make observations to determine the efficacy of depilatory creams in reducing pseudofolliculits barbae.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* PFB patient\n\nExclusion Criteria:\n\n* Failed sensitivity testing'}, 'identificationModule': {'nctId': 'NCT04220502', 'briefTitle': "Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae", 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': "Depilatory Cream's Affect on the Occurrence of Pseudofolliculitis Barbae", 'orgStudyIdInfo': {'id': 'WayneMed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magic Shave Powder Gold', 'description': 'This group will receive magic shaving powder gold and instructions on how to apply it. They will keep a log for their facial hair removal', 'interventionNames': ['Drug: Magic Shave Powder Gold']}, {'type': 'OTHER', 'label': 'Traditional Methods', 'description': 'This group will continue using traditional razors with the standard of care directions to shave. They will keep a log of their facial hair removal', 'interventionNames': ['Device: Traditional Shaving Methods']}], 'interventions': [{'name': 'Magic Shave Powder Gold', 'type': 'DRUG', 'otherNames': ['Experimental'], 'description': 'Depilatory Cream for facial hair removal', 'armGroupLabels': ['Magic Shave Powder Gold']}, {'name': 'Traditional Shaving Methods', 'type': 'DEVICE', 'otherNames': ['Control'], 'description': 'Continued facial hair removal using traditional razors', 'armGroupLabels': ['Traditional Methods']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University Physician Group Dermatology', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}], 'overallOfficials': [{'name': 'Steven Daveluy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow of the American Academy of Dermatology', 'investigatorFullName': 'Steven D Daveluy', 'investigatorAffiliation': 'Wayne State University'}}}}