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

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)

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.

Study Overview

• Status: Completed
• Conditions: AGA
• Intervention / Treatment: Drug: CU-40102 Spray

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 37 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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 persistent requirement to wear a wig sheath during study treatments;
5. Known allergy to the active ingredient of the investigational drug or any component of the 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CU-40102 Spray; 0.25% (2.275mg/mL) Finasteride	Drug: CU-40102 Spray; topical application, 1~4 sprays each time, once daily
Placebo Comparator: Placebo for CU-40102 Spray; Placebo Spray	Drug: CU-40102 Spray; topical application, 1~4 sprays each time, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of TAHC	the change from baseline in target area hair count (TAHC) in the vertex after treatment	24 weeks.

Collaborators and Investigators

• Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: CU-40102-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No