A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)

CU-40102-303

A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.

2021-12-06

2023-03-07

2023-05-15

Completed

Early phase I

270

Inclusion Criteria: 1. Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure; 2. Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits; 3. Males aged 18 to 41 years (inclusive); 4. Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA) according to the Hamilton-Norwood classification (see Appendix 1 for details); 5. Appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; - Exclusion Criteria: 1. A history of scalp skin abnormalities or scalp skin diseases at the time of screening 2. Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus; 3. Patients with alopecia areata, alopecia cicatrisata, or trichotillomania; 4. Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments; 5. Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid; 6. A history of depression, anxiety, personality disorder or other mental disorders; 7. A history of varicocele or infertility ; 8. A history of malignant tumor;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 270, 'type': 'ACTUAL'}}

2023-08-01