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Completed

NCT Number: NCT05135468

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

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.

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Key information

Conditions

AGA

Age range

18 year–41 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People Hosptial

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

CU-40102 Spray

Drug

topical application, 1~4 sprays each time, once daily

Primary outcomes

  1. The Rate of TAHC

    Time frame: 24 weeks.

    the change from baseline in target area hair count (TAHC) in the vertex after treatment

Sponsors and collaborators

Lead sponsor

Cutia Therapeutics(Wuxi)Co.,Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 26, 2021
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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