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Phase II Clinical Trial of MH004 Ointment in Patients With Non-segmental Vitiligo

NCT07181187 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-09-18

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, vehicle-controlled phase II study of MH004 Ointment with a 28-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with vitiligo.

Conditions

  • Vitiligo

Interventions

DRUG

MH004 Ointment

MH004 1% ointment applied topically to the affected area as a thin film once or twice daily.

DRUG

Vehicle Ointment

Matching vehicle ointment applied topically to the affected area as a thin film once or twice daily.

Sponsors & Collaborators

  • Minghui Pharmaceutical (Hangzhou) Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-26
Primary Completion
2025-10-14
Completion
2026-05-14

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 NCT07181187 on ClinicalTrials.gov