A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
Phase 3
Completed
- Conditions
- AGA
- Interventions
- Drug: CU-40102 Spray
- Registration Number
- NCT05135468
- Lead Sponsor
- Cutia Therapeutics（Wuxi）Co.,Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 270
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CU-40102 Spray CU-40102 Spray 0.25% (2.275mg/mL) Finasteride Placebo for CU-40102 Spray CU-40102 Spray Placebo Spray
- Primary Outcome Measures
Name Time Method The Rate of TAHC 24 weeks. the change from baseline in target area hair count (TAHC) in the vertex after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University People Hosptial
🇨🇳Beijing, Beijing, China