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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Having voluntarily signed the ICF approved by the Ethics Committee and consented toparticipate in this study before starting any study procedure;
- Being able to understand and comply with the requirements of the protocol and agreeingto participate in all study visits;
- Males aged 18 to 41 years (inclusive);
- 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);
- 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:
- A history of scalp skin abnormalities or scalp skin diseases at the time of screening
- Patients with secondary alopecia such as those associated with malnutrition, drugs,endocrine , iron deficiency anemia, or systemic lupus erythematosus;
- Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
- Having undergone hair transplantation or extension before screening, or persistentrequirement to wear a wig sheath during study treatments;
- Known allergy to the active ingredient of the investigational drug or any component ofthe excipients, or to any component of the tattoo liquid;
- A history of depression, anxiety, personality disorder or other mental disorders;
- A history of varicocele or infertility ;
- 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
ChinaSite 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.