A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd

Criteria

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;