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

Last updated: April 1, 2024
Sponsor: Suzhou Kintor Pharmaceutical Inc,
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hair Loss

Male Pattern Baldness

Scalp Disorders

Treatment

Placebo

KX-826-(5%) BID

Clinical Study ID

NCT06126965
KX0826-CN-1003
  • Ages > 18
  • Male

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in thestudy, 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

Exclusion Criteria:

  1. Have used androgen replacement therapy, immunosuppressants, corticosteroids and otherdrugs 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 priorto screening;
  6. Those who, in the opinion of the investigator, have other conditions that may affectcompliance or are not suitable for participation in this study.

Study Design

Total Participants: 740
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 29, 2021
Estimated Completion Date:
May 31, 2024

Study 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.

Connect with a study center

  • The Second Hospital Of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Tongren Hospital,Cmu

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Sir Run Run Shaw Hospital,ZheJiang University School Of Medicine

    Zhejiang, Hangzhou
    China

    Site Not Available

  • The First Hospital Of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The First Affiliated Hospital Of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Wuhan Hospital Of Traditional Chinese And Western Medicine

    Wuhan, Hubei
    China

    Site Not Available

  • The Second Xiangya Hospital Of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu
    China

    Site Not Available

  • The First Hospital Of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Huashan Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdou, Sichuan
    China

    Site Not Available

  • Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Affiliated Hangzhou First People's Hospital,Zhejiang University School Of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.