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

• ClinicalTrials.gov Identifier: NCT05135468
• Recruitment Status: Active, not recruiting
• First Posted: November 26, 2021
• Last Update Posted: August 10, 2022
• Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd
• Information provided by (Responsible Party): Cutia Therapeutics（Wuxi）Co.,Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
AGA	Drug: CU-40102 Spray	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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)
• Actual Study Start Date: December 6, 2021
• Estimated Primary Completion Date: March 30, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The Rate of TAHC [ Time Frame: 24 weeks. ]
   the change from baseline in target area hair count (TAHC) in the vertex after treatment

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 41 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

China, Beijing

Peking University People Hosptial

Beijing, Beijing, China, 100044

Sponsors and Collaborators

Cutia Therapeutics（Wuxi）Co.,Ltd

More Information

• Responsible Party: Cutia Therapeutics（Wuxi）Co.,Ltd
• ClinicalTrials.gov Identifier: NCT05135468
• Other Study ID Numbers: CU-40102-303
• First Posted: November 26, 2021
• Last Update Posted: August 10, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical