Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT06355856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy/ Safety of DNN.22.17.036 in Male Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage variation of hairs in the hair loss phase', 'timeFrame': '180 days', 'description': 'Percentage variation of hairs in the hair loss phase (telogen hairs), by image analysis with the FotoFinder Leviacam®, after 180 days of treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia']}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)\n* Male participants age 25 or older and 60 age or younger\n* Participants who have an intact scalp in the area of product analysis\n* Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale \\> II\n* Participants with at least 20% telogen effluvium of evaluated by Tricholab\n\nExclusion Criteria:\n\n* Participants who have used immunosuppressants in the 3 months prior to signing the ICF\n* Participants with other causes of hair loss or scalp dermatoses\n* Participants who have received hair loss treatment in the last 6 months\n* Participants with uncontrolled medical conditions, kidney and liver disease\n* Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss'}, 'identificationModule': {'nctId': 'NCT06355856', 'acronym': 'CAPELLI', 'briefTitle': 'Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ache Laboratorios Farmaceuticos S.A.'}, 'officialTitle': 'Phase IV, National, Unicentric, Comparative, Double-Blind, Randomized, Non- Inferiority Clinical Trial to Evaluate the Efficacy and Safety of DNN.22.17.036 Compared to 10573048700 in the Treatment of Androgenetic Alopecia', 'orgStudyIdInfo': {'id': 'ACH-PNT-04(01/22)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DNN.22.17.036', 'description': 'Apply 1 ml to the bald area of the scalp, twice a day for 180 days.', 'interventionNames': ['Drug: DNN.22.17.036']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10573048700', 'description': 'Apply 1 ml to the bald area of the scalp, twice a day for 180 days.', 'interventionNames': ['Drug: 10573048700']}], 'interventions': [{'name': 'DNN.22.17.036', 'type': 'DRUG', 'description': 'Apply twice daily to the affected area and around it.', 'armGroupLabels': ['DNN.22.17.036']}, {'name': '10573048700', 'type': 'DRUG', 'description': 'Apply twice daily to the affected area and around it.', 'armGroupLabels': ['10573048700']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Renata Herrera', 'role': 'CONTACT', 'email': 'pesquisa.clinica@ache.com.br', 'phone': '(55-11) 97216-3958'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ache Laboratorios Farmaceuticos S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}