Phase III Study of KX-826 With Adult Male Patients With AGA

• Status: Active, not recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: Male

Summary

This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).

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

Details

• Lead Sponsor: Suzhou Kintor Pharmaceutical Inc,
• Collaborator: Suzhou Koshine Biomedica, Inc.

Criteria

Inclusion Criteria:

1. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;

2. Male, ≥ 18 old;

3. Clinically diagnosed as androgenetic alopecia;

4. Rating IIIv, IV and V on Hamilton-Norwood scale;

Exclusion Criteria:

1. Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;

2. Have used minoxidil within 6 months prior to screening;

3. Have used finasteride or dutasteride within 12 months prior to screening;

4. Had used topical drugs for alopecia sites within 3 months prior to screening;

5. Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;

6. Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.