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

Cutia Therapeutics

Status and phase: Completed; Phase 3

Conditions: AGA

Treatments: Drug: CU-40102 Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT05135468

CU-40102-303

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: Male

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 2 patient groups, including a placebo group

CU-40102 Spray

Experimental group

Description:

0.25% (2.275mg/mL) Finasteride

Treatment:

Drug: CU-40102 Spray

Placebo for CU-40102 Spray

Placebo Comparator group

Description:

Placebo Spray

Treatment:

Drug: CU-40102 Spray