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

NCT ID: NCT05135468

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2023-05-15

Brief 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.

Conditions

AGA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CU-40102 Spray

0.25% (2.275mg/mL) Finasteride

Group Type: EXPERIMENTAL

CU-40102 Spray

Intervention Type: DRUG

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

Placebo for CU-40102 Spray

Placebo Spray

Group Type: PLACEBO_COMPARATOR

CU-40102 Spray

Intervention Type: DRUG

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

Interventions

CU-40102 Spray

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cutia Therapeutics（Wuxi）Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People Hosptial

Beijing, Beijing Municipality, China

Countries

China

References

Zhou C, Yang B, Zeng H, Xia R, Dang N, Yang Q, Li J, Zhang C, Zhang G, Wei A, Lai W, Yang S, Diao Q, Ding Y, Wu L, Liu L, Jia D, Zhu H, Zhang J. Efficacy and safety of topical finasteride spray solution in the treatment of Chinese men with androgenetic alopecia: A phase III, multicenter, randomized, double-blind, placebo-controlled study. Chin Med J (Engl). 2025 Mar 17. doi: 10.1097/CM9.0000000000003495. Online ahead of print.

Reference Type: DERIVED

PMID: 40090937 (View on PubMed)

Other Identifiers

CU-40102-303

Identifier Type: -

Identifier Source: org_study_id