Status:
UNKNOWN
Phase III Study of KX-826 With Adult Male Patients With AGA
Lead Sponsor:
Suzhou Kintor Pharmaceutical Inc,
Collaborating Sponsors:
Suzhou Koshine Biomedica, Inc.
Conditions:
Androgenetic Alopecia
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 androge...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT06126965
Start Date
December 29 2021
End Date
May 31 2024
Last Update
April 3 2024
Active Locations (26)
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1
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
2
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
3
Beijing Tongren Hospital,Cmu
Beijing, Beijing Municipality, China
4
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China