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

NCT05135468 | Completed Phase 3

• 1 other identifier: CU-40102-303
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The Rate of TAHC

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

  24 weeks.

Study Arms (2)

CU-40102 Spray

EXPERIMENTAL

0.25% (2.275mg/mL) Finasteride

Drug: CU-40102 Spray

Placebo for CU-40102 Spray

PLACEBO COMPARATOR

Placebo Spray

Drug: CU-40102 Spray

Interventions

CU-40102 Spray DRUG

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

CU-40102 Spray; Placebo for CU-40102 Spray

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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; -

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Peking University People Hosptial

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

• 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.

  PMID: 40090937 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 26, 2021
• Study Start: December 6, 2021
• Primary Completion: March 7, 2023
• Study Completion: May 15, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)