A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)

Last updated: July 31, 2023
Sponsor: Cutia Therapeutics(Wuxi)Co.,Ltd
Overall Status: Completed

Phase

3

Condition

Alopecia

Hair Loss

Treatment

CU-40102 Spray

Clinical Study ID

NCT05135468
CU-40102-303
  • Ages 18-41
  • Male

Study Summary

A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Having voluntarily signed the ICF approved by the Ethics Committee and consented toparticipate in this study before starting any study procedure;
  2. Being able to understand and comply with the requirements of the protocol and agreeingto participate in all study visits;
  3. Males aged 18 to 41 years (inclusive);
  4. Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA)according to the Hamilton-Norwood classification (see Appendix 1 for details);
  5. Appropriate medical contraceptive methods being used to prevent the sexual partnerfrom becoming pregnant from the time of signing ICF to 28 days after the last dose; -

Exclusion

Exclusion Criteria:

  1. A history of scalp skin abnormalities or scalp skin diseases at the time of screening
  2. Patients with secondary alopecia such as those associated with malnutrition, drugs,endocrine , iron deficiency anemia, or systemic lupus erythematosus;
  3. Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
  4. Having undergone hair transplantation or extension before screening, or persistentrequirement to wear a wig sheath during study treatments;
  5. Known allergy to the active ingredient of the investigational drug or any component ofthe excipients, or to any component of the tattoo liquid;
  6. A history of depression, anxiety, personality disorder or other mental disorders;
  7. A history of varicocele or infertility ;
  8. A history of malignant tumor;

Study Design

Total Participants: 270
Treatment Group(s): 1
Primary Treatment: CU-40102 Spray
Phase: 3
Study Start date:
December 06, 2021
Estimated Completion Date:
May 15, 2023

Connect with a study center

  • Peking University People Hosptial

    Beijing, Beijing 100044
    China

    Site Not Available

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