Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT02793557
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-02', 'releaseDate': '2021-03-09'}, {'resetDate': '2021-10-19', 'releaseDate': '2021-09-22'}], 'estimatedResultsFirstSubmitDate': '2021-03-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006983', 'term': 'Hypertrichosis'}, {'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D006628', 'term': 'Hirsutism'}], 'ancestors': [{'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014770', 'term': 'Virilism'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-29', 'studyFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2016-06-03', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2', 'timeFrame': '3 months'}, {'measure': 'Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs', 'timeFrame': '3 months'}, {'measure': 'Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertrichosis', 'Alopecia', 'Hirsutism']}, 'descriptionModule': {'briefSummary': 'A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.', 'detailedDescription': "SAD part:\n\nA total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3.\n\nMD part:\n\nIn total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly\n\nEach injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male, aged 18-45 years\n* Clinically visible terminal hair growth on thighs\n\nExclusion Criteria:\n\n* Damaged skin in or around test sites\n* History of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial\n* History or clinical signs of keloids or hypertrophic scars\n* Immunological disorders such as alopecia areata, and systemic lupus erythematosus\n* Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new oral anticoagulants)\n* Current or within 3 months prior to first dosing use of anti-inflammatory medication, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks\n* Current or within 3 months prior to first dosing use of medication with hair growth modifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens\n* Current or within 12 months prior to first dosing intake of anabolics or 5-alpha reductase inhibitors\n* Current or within one week prior to first dosing use of any topical drugs on the legs'}, 'identificationModule': {'nctId': 'NCT02793557', 'briefTitle': 'Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Follicum AB'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'FCS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'FOL-005: Solution 1', 'description': 'Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.', 'interventionNames': ['Drug: FOL-005']}, {'type': 'EXPERIMENTAL', 'label': 'FOL-005: Solution 2', 'description': 'Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.', 'interventionNames': ['Drug: FOL-005']}, {'type': 'EXPERIMENTAL', 'label': 'FOL-005: Solution 3', 'description': 'Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.', 'interventionNames': ['Drug: FOL-005']}, {'type': 'EXPERIMENTAL', 'label': 'FOL-005: Solution 4', 'description': 'Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.', 'interventionNames': ['Drug: FOL-005']}], 'interventions': [{'name': 'FOL-005', 'type': 'DRUG', 'description': 'Intradermal injection of 50 μl solution', 'armGroupLabels': ['FOL-005: Solution 1', 'FOL-005: Solution 2', 'FOL-005: Solution 3', 'FOL-005: Solution 4']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Ulrike Blume-Peytavi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Follicum AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-09', 'type': 'RELEASE'}, {'date': '2021-04-02', 'type': 'RESET'}, {'date': '2021-09-22', 'type': 'RELEASE'}, {'date': '2021-10-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Follicum AB'}}}}