NCT07181187

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This phase II trial of MH004 Ointment comprises two periods: a vehicle control period and an open-label long-term safety extension period. Participants will be randomly aligned to the 1.0% MH004 Ointment or Vehicle arms and treated for up to 24 weeks, followed by a 28-week open-label LTS treatment period with 1.0% MH004 Ointment. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with vitiligo.

Conditions

• Vitiligo

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-26
• Primary completion: 2025-10-14
• Completion: 2026-05-14
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: China