Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-05 @ 5:37 PM
Study NCT ID:
NCT02154503
Status:
UNKNOWN
Last Update Posted:
2014-06-03
First Post:
2014-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097244', 'term': 'Percutaneous Collagen Induction'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-02', 'studyFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hair caliber diameter and hair counts will be measured on both the treated and untreated sides.', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'Adverse effects of the procedure will be recorded.', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'Androgenetic Alopecia is the most common non scarring alopecia worldwide. Treatment of which has been limited with few options for medical and surgical treatment, the cost of the latter being prohibitive for many. Recently there have been several new modalities proposed as treatment, namely Microneedling and Platelet Rich Plasma.\n\nMicroneedling has been shown to overexpress hair growth factors which may enhance or stimulate miniaturized hairs to grow. It has also been shown to increase the absorption of topical products significantly. The exact mechanism of action of Microneedling is still being delineated.\n\nIn this study, we aim to do a half lesional study with global photographs and hair counts done at the start of , week four and week twelve. Patients would be needled once weekly after application of topical anaesthetic (5% EMLA). If by week six there is significant regrowth (\\>30%), then total lesional needling will be done. Patients will only be using topical 5% Minoxidil throughout the study as this will prolong the effects of the regrowth.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men between the ages 18-65.\n2. Disease Stage: Norwood Hamilton IIIa-IV.\n3. Length of time with disease \\< 10 years.\n\nExclusion Criteria:\n\n1. Must not have other concurrent hair disease.\n2. Have not used any oral anti androgen (Finasteride or Dutasteride) in the past six months. If so, a washout period is needed. One month for Finasteride and three months for Dutasteride.\n3. Patients under the age of 18.\n4. Patients who are unable to offer consent.'}, 'identificationModule': {'nctId': 'NCT02154503', 'briefTitle': 'Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'Vancouver General Hospital'}, 'officialTitle': 'Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia- Pilot Study', 'orgStudyIdInfo': {'id': 'H13-03501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microneedling', 'description': 'By randomization, the side for treatment will be determined. Topical anaesthetic will be then placed onto the treatment area under occlusion for thirty minutes to one hour. This will then be removed with 70% alcohol. The area will be rolled with microneedles in two planes: coronally and sagitally. In each plane, five passes will be made. Patients will restart application of Minoxidil the following day to both sides of the lesion.\n\nThe same half of the scalp will be treated for the rest of the sessions, with topical anaesthetic applied by patient 30 minutes to an hour prior to start of treatment session. Patients will undergo microneedling on alternate weeks for a total of six treatments in 12 weeks. If there is \\>30% growth seen after six weeks, then the entire area will be treated.', 'interventionNames': ['Device: topical 5% Minoxidil (Microneedling)']}], 'interventions': [{'name': 'topical 5% Minoxidil (Microneedling)', 'type': 'DEVICE', 'armGroupLabels': ['Microneedling']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4E8', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jerry Shapiro, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Skin Care Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Jerry Shapiro, MD', 'role': 'CONTACT', 'email': 'jerry.shapiro@vch.ca', 'phone': '6048755151'}, {'name': 'Llorenia Muir-Green, MBBS', 'role': 'CONTACT', 'email': 'Llorenia.MuirGreen@vch.ca', 'phone': '6048755151'}], 'overallOfficials': [{'name': 'Jerry Shapiro, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vancouver General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jerry Shapiro', 'investigatorAffiliation': 'Vancouver General Hospital'}}}}