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

ACH-PNT-04(01/22)

Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.

2024-04-01

2025-05-01

2025-05-01

Not yet recruiting

Early phase I

196

Inclusion Criteria: * Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF) * Male participants age 25 or older and 60 age or younger * Participants who have an intact scalp in the area of product analysis * Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale \> II * Participants with at least 20% telogen effluvium of evaluated by Tricholab Exclusion Criteria: * Participants who have used immunosuppressants in the 3 months prior to signing the ICF * Participants with other causes of hair loss or scalp dermatoses * Participants who have received hair loss treatment in the last 6 months * Participants with uncontrolled medical conditions, kidney and liver disease * Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 196, 'type': 'ESTIMATED'}}

2024-04-10