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

  • End date
    Jun 30, 2023
  • participants needed
  • sponsor
    Cutia Therapeutics(Wuxi)Co.,Ltd
Updated on 25 March 2022


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.

Condition AGA
Treatment CU-40102 Spray
Clinical Study IdentifierNCT05135468
SponsorCutia Therapeutics(Wuxi)Co.,Ltd
Last Modified on25 March 2022


Yes No Not Sure

Inclusion Criteria

Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure
Being able to understand and comply with the requirements of the protocol and agreeing to 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 partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; -

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 persistent requirement to wear a wig sheath during study treatments
Known allergy to the active ingredient of the investigational drug or any component of the 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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