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To Evaluate Efficacy and Safety of TopicalKX-826 Solution in Chinese Male Patients With Androgenetic Alopecia

NCT06622824 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2024-10-21

No results posted yet for this study

Summary

This study is a multicenter, randomized, double-blind, vehicle controlled, adaptive design phase 2/3 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia (AGA). It consisted of two phases, phase 2 dose exploration trial and phase 3 confirmatory trial.

Conditions

  • Androgenetic Alopecia (AGA)

Interventions

DRUG

KX-826 0.5% BID

0.5% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks

DRUG

KX-826 1.0% BID

1.0% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks

DRUG

Vehicle (Placebo) applied BID

Matching placebo applied topically to scalp twice daily for 24 weeks

Sponsors & Collaborators

  • Suzhou Koshine Biomedica, Inc.

    collaborator INDUSTRY

  • Suzhou Kintor Pharmaceutical Inc,

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2027-10-20
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622824 on ClinicalTrials.gov