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

K

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

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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