Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01391156
Status:
COMPLETED
Last Update Posted:
2012-07-20
First Post:
2011-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss
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': 'D008914', 'term': 'Minoxidil'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-19', 'studyFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean change of hair count from baseline and 6 months', 'timeFrame': 'baseline and 6 months', 'description': 'Total hair count on the vertex is measured on 1 cm2 circular area. The mean change in hair count is compared at baseline and 6 months.The significance of change is determined by Unpaired t Test.'}], 'secondaryOutcomes': [{'measure': 'Global photographic assessment by dermatologists', 'timeFrame': 'baseline and 6 months', 'description': 'Photographs of the vertex scalp are taken at baseline and 6 months. A panel of 3 dermatologists assesssed the change in hair growth using a 7-point scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['minoxidil', 'finasteride', 'topical', 'lotion', 'male pattern hair loss', 'androgenetic alopecia'], 'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion for 6 months in male pattern hair loss.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male, age 18-15 years\n* androgenetic alopecia grade 3V to 5 ( Norwood-Hamilton classification)\n\nExclusion Criteria:\n\n* use minoxidil in 6 months\n* use finasteride in 12 months\n* use ketoconazole, tar, selenium shampoo, topical tretinoin, topical steroid in 2 weeks\n* seborrheic dermatitis or psoriasis on scalp\n* history of allergy to minoxidil, finasteride'}, 'identificationModule': {'nctId': 'NCT01391156', 'briefTitle': 'Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss', 'organization': {'class': 'OTHER', 'fullName': 'Mae Fah Luang University Hospital'}, 'officialTitle': 'Efficacy of 3% Minoxidil Versus Combined 3% Minoxidil and 0.1% Finasteride for Male Pattern Hair Loss: a Randomized, Double-blinded, Comparative Study', 'orgStudyIdInfo': {'id': 'REH-54015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minoxidil', 'interventionNames': ['Drug: 3%Minoxidil lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MinoxidilFinasteride', 'interventionNames': ['Drug: 3% Minoxidil with 0.1% Finasteride lotion']}], 'interventions': [{'name': '3%Minoxidil lotion', 'type': 'DRUG', 'description': '3% Minoxidil lotion apply two times a day', 'armGroupLabels': ['Minoxidil']}, {'name': '3% Minoxidil with 0.1% Finasteride lotion', 'type': 'DRUG', 'description': '3% Minoxidil with 0.1% Finasteride lotion apply two times a day.', 'armGroupLabels': ['MinoxidilFinasteride']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Mae Fah Luang University Hospital(Bangkok)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Chuchai Tanglertsampan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mae Fah Luang University Hospital(Bangkok)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mae Fah Luang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chuchai Tanglertsampan, MD', 'investigatorFullName': 'Chuchai TANGLERTSAMPAN, MD', 'investigatorAffiliation': 'Mae Fah Luang University Hospital'}}}}