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

Launched by SUZHOU KINTOR PHARMACEUTICAL INC, · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called KX-826, which is applied directly to the scalp, to see if it helps adult men with androgenetic alopecia (AGA), also known as male pattern baldness. The trial is currently active but not recruiting new participants. To be eligible, participants must be men aged 18 or older who have been diagnosed with AGA and show specific patterns of hair loss. However, certain individuals are not allowed to join, such as those who have used specific hair loss treatments or medications in the past few months.

Participants in this study can expect to follow a treatment plan and attend regular visits. Throughout the trial, they will receive either KX-826 or a placebo (a substance with no active treatment) without knowing which one they’re getting, as this is a double-blind study. This helps ensure that the results are unbiased. Overall, this trial aims to find out if KX-826 is an effective and safe option for treating hair loss in men with AGA.

Gender

MALE

Eligibility 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.