A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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AGA

Intervention / Treatment
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* Drug: CU-40102 Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure; Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits; Males aged 18 to 41 years (inclusive); 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); 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: A history of scalp skin abnormalities or scalp skin diseases at the time of screening Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus; Patients with alopecia areata, alopecia cicatrisata, or trichotillomania; Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments; Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid; A history of depression, anxiety, personality disorder or other mental disorders; A history of varicocele or infertility ; A history of malignant tumor;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CU-40102 Spray<br>0.25% (2.275mg/mL) Finasteride | Drug: CU-40102 Spray<br>* topical application, 1 4 sprays each time, once daily<br>|
| Placebo Comparator: Placebo for CU-40102 Spray<br>Placebo Spray | Drug: CU-40102 Spray<br>* topical application, 1 4 sprays each time, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of TAHC | the change from baseline in target area hair count (TAHC) in the vertex after treatment | 24 weeks. |