Phase III Study of KX-826 With Adult Male Patients With AGA

Kintor Pharmaceutical

Status and phase: Active, not recruiting; Phase 3

Conditions: Androgenetic Alopecia

Treatments: Drug: KX-826-（5%） BID; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06126965

KX0826-CN-1003

Details and patient eligibility

About

This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).

Full description

In this study, around 740 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.

Enrollment: 740 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
2. Male, ≥ 18 old;
3. Clinically diagnosed as androgenetic alopecia;
4. Rating IIIv, IV and V on Hamilton-Norwood scale;

Exclusion criteria

1. Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
2. Have used minoxidil within 6 months prior to screening;
3. Have used finasteride or dutasteride within 12 months prior to screening;
4. Had used topical drugs for alopecia sites within 3 months prior to screening;
5. Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
6. Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

740 participants in 2 patient groups, including a placebo group

KX-826-0.5% BID

Experimental group

Description:

treatment dose group of 0.5% BID(0.5%)

Treatment:

Drug: KX-826-（5%） BID

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo