NCT07185282

A Phase 3 Study of MH004 Ointment in Patients With Mild to Moderate Atopic Dermatitis

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of MH004 Ointment Followed by a 44-week Open-Label Long-Term Safety Extension Period in Adolescents and Adults With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-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 mild to moderate atopic dermatitis.

Detailed description

This phase III 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 BID or Vehicle BID arm and treated for up to 8 weeks, followed by a 44-week open-label LTS treatment period with 1.0% MH004 Ointment BID. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with mild to moderate atopic dermatitis (AD).

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	MH004 Ointment	MH004 1% ointment applied topically to the affected area as a thin film twice daily.
DRUG	Vehicle Ointment	Matching vehicle ointment applied topically to the affected area as a thin film twice daily.

Timeline

• Start date: 2023-06-10
• Primary completion: 2024-12-13
• Completion: 2025-08-15
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: China