Completed
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)
What is being tested
CU-40102 Spray
Drug
Who is being recruted
From 18 to 41 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: December 2021
Summary
Principal SponsorCutia Therapeutics（Wuxi）Co.,Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 6, 2021
Actual date on which the first participant was enrolled.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 TitleA 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)
Principal SponsorCutia Therapeutics（Wuxi）Co.,Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
270 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 41 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
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);
Show More Criteria
8 exclusion criteria prevent from participating
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;
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Experimental0.25% (2.275mg/mL) Finasteride
Group II
PlaceboPlacebo Spray
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Peking University People Hosptial
Beijing, ChinaOpen Peking University People Hosptial in Google MapsCompletedOne Study Center