Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-04-18 @ 12:36 AM
Study NCT ID:
NCT02198261
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minoxidil Response Testing in Males With 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': '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plucked hair follicles with visible bulbs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2014-07-22', 'lastUpdatePostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair count in the target region', 'timeFrame': 'baseline to week 16'}, {'measure': 'Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings', 'timeFrame': 'baseline to week 16'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth', 'timeFrame': 'baseline to week 16'}, {'measure': 'Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region', 'timeFrame': 'baseline to week 16'}, {'measure': 'Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit', 'timeFrame': 'baseline to week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alopecia', 'androgenetic alopecia', 'hair loss', 'minoxidil', '5% minoxidil foam', 'male pattern hair loss'], 'conditions': ['Androgenetic Alopecia']}, 'referencesModule': {'references': [{'pmid': '24773771', 'type': 'BACKGROUND', 'citation': 'Roberts J, Desai N, McCoy J, Goren A. Sulfotransferase activity in plucked hair follicles predicts response to topical minoxidil in the treatment of female androgenetic alopecia. Dermatol Ther. 2014 Jul-Aug;27(4):252-4. doi: 10.1111/dth.12130. Epub 2014 Apr 28.'}, {'pmid': '24283387', 'type': 'BACKGROUND', 'citation': 'Goren A, Castano JA, McCoy J, Bermudez F, Lotti T. Novel enzymatic assay predicts minoxidil response in the treatment of androgenetic alopecia. Dermatol Ther. 2014 May-Jun;27(3):171-3. doi: 10.1111/dth.12111. Epub 2013 Nov 27.'}, {'pmid': '2230218', 'type': 'BACKGROUND', 'citation': 'Buhl AE, Waldon DJ, Baker CA, Johnson GA. Minoxidil sulfate is the active metabolite that stimulates hair follicles. J Invest Dermatol. 1990 Nov;95(5):553-7. doi: 10.1111/1523-1747.ep12504905.'}, {'pmid': '14996087', 'type': 'BACKGROUND', 'citation': 'Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x.'}]}, 'descriptionModule': {'briefSummary': 'Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.\n\nMinoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.\n\nConsequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.\n\nThe primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males with androgenetic alopecia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males in overall good health\n* Age: 18 to 49\n* Diagnosed with male androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale\n* Willing to have a mini dot tattoo placed in the target area of the scalp\n* Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study\n* Able to give informed consent\n* Able to comply with the study requirements for 16 consecutive weeks\n\nExclusion Criteria:\n\n* Previous adverse event from topical minoxidil treatment\n* Does not use and have not used in the past 6 months anti-androgen therapy such as finasteride\n* Does not use and have not used in the past 6 months minoxidil (topical or oral)\n* Does not take medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics\n* Folliculitis\n* Scalp psoriasis\n* Seborrheic dermatitis\n* Inflammatory scalp conditions such as lichen planopilaris'}, 'identificationModule': {'nctId': 'NCT02198261', 'briefTitle': 'Minoxidil Response Testing in Males With Androgenetic Alopecia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Applied Biology, Inc.'}, 'officialTitle': 'Minoxidil Response Testing in Males With Androgenetic Alopecia', 'orgStudyIdInfo': {'id': 'AB-IVD-MINOXIDIL-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Predicted as non-responders', 'description': 'Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.', 'interventionNames': ['Drug: 5% minoxidil topical foam']}, {'label': 'Predicted as responders', 'description': 'Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.', 'interventionNames': ['Drug: 5% minoxidil topical foam']}], 'interventions': [{'name': '5% minoxidil topical foam', 'type': 'DRUG', 'otherNames': ['Rogaine 5% minoxidil foam', 'Regaine 5% minoxidil foam'], 'description': '5% minoxidil topical foam', 'armGroupLabels': ['Predicted as non-responders', 'Predicted as responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Physicians Hair Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '3002', 'city': 'East Melbourne', 'country': 'Australia', 'facility': 'Sinclair Dermatology', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '400022', 'city': 'Mumbai', 'country': 'India', 'facility': 'LTM Medical College & Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '50127', 'city': 'Florence', 'country': 'Italy', 'facility': 'Istituto Medico Tricologico/Studi Life Cronos', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'Sharon Keene, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physicians Hair Institute'}, {'name': 'Flavio Grasso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Medico Tricologico/Studi Life Cronos'}, {'name': 'Rodney Sinclair, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sinclair Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Applied Biology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}