AGA
Conditions
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.
Interventions
DRUGCU-40102 Spray
topical application, 1\ 4 sprays each time, once daily
Sponsors
Cutia Therapeutics（Wuxi）Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
Eligibility
Sex/Gender
MALE
Age
18 Years to 41 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of TAHC | 24 weeks. | the change from baseline in target area hair count (TAHC) in the vertex after treatment |
Countries
China
Outcome results
None listed