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)
Overview
- Phase
- Phase 3
- Intervention
- KX-826-（5%） BID
- Conditions
- Androgenetic Alopecia
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Enrollment
- 740
- Locations
- 26
- Primary Endpoint
- change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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).
Detailed Description
In this study, around 740 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
- •Male, ≥ 18 old;
- •Clinically diagnosed as androgenetic alopecia;
- •Rating IIIv, IV and V on Hamilton-Norwood scale;
Exclusion Criteria
- •Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
- •Have used minoxidil within 6 months prior to screening;
- •Have used finasteride or dutasteride within 12 months prior to screening;
- •Had used topical drugs for alopecia sites within 3 months prior to screening;
- •Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
- •Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.
Arms & Interventions
KX-826-0.5% BID
treatment dose group of 0.5% BID(0.5%)
Intervention: KX-826-（5%） BID
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
Time Frame: mean change from baseline after 24 weeks of treatment
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
Secondary Outcomes
- Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment)(change from baseline after 6, 12, 18, and 24 weeks of treatment)
- Secondary Outcome Measure:(change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method)