Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04594018
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2020-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Finlândia Hair Lotion Association on 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'}, {'id': 'D018120', 'term': 'Finasteride'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in hair density.', 'timeFrame': '6 months', 'description': 'Digital phototrichogram evaluation of vertex area regarding the change from baseline in number of hairs after 6 months of treatment compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events recorded during the study.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['androgenetic alopecia'], 'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test.\n\nExclusion Criteria:\n\n* Known hypersensitivity to the formula components used during the clinical trial;\n* History of alcohol and/or substance abuse within 2 years;\n* Participants with other concomitant dermatological diseases on the scalp, except for mild seborrhoea dermatitis;\n* Participants with a history of surgical treatment for hair loss or shaved scalp;\n* Participants who used shampoo or topical solution containing ketoconazole, tar, selenium, threonine or steroids in the last 2 weeks;\n* Participants who used 5α reductase inhibitors, such as finasteride and dutasteride, in the last 12 months;\n* Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel;\n* Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months;\n* Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year;\n* Participants with diseases that can affect hair growth;\n* Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;'}, 'identificationModule': {'nctId': 'NCT04594018', 'briefTitle': 'Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association in the Treatment of Androgenetic Alopecia.', 'orgStudyIdInfo': {'id': 'EMS2119 - FINLÂNDIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FINLÂNDIA', 'description': 'The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow:\n\n1 tablet finasteride placebo, oral, once a day.\n\n1 mL Finlândia hair lotion, topical, twice a day.', 'interventionNames': ['Drug: Finlândia Association + finasteride placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minoxidil + finasteride', 'description': 'The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow:\n\n1 tablet finasteride, oral, once a day.\n\n1 mL minoxidil hair lotion, topical, twice a day.', 'interventionNames': ['Drug: Minoxidil + finasteride']}], 'interventions': [{'name': 'Finlândia Association + finasteride placebo', 'type': 'DRUG', 'description': 'Finlândia association hair lotion + finasteride placebo', 'armGroupLabels': ['FINLÂNDIA']}, {'name': 'Minoxidil + finasteride', 'type': 'DRUG', 'description': 'Minoxidil hair lotion + Finasteride 1 mg', 'armGroupLabels': ['Minoxidil + finasteride']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osasco', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'FLAVIA ADDOR', 'role': 'CONTACT', 'phone': '551136816362'}], 'facility': 'Medcin Instituto Da Pele', 'geoPoint': {'lat': -23.5325, 'lon': -46.79167}}], 'centralContacts': [{'name': 'Monalisa FB Oliveira, MD', 'role': 'CONTACT', 'email': 'pesquisa.clinica@ncfarma.com.br', 'phone': '+551938879851'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}