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

NCT07185282 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Atopic Dermatitis (AD)

Interventions

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.

Sponsors & Collaborators

  • Minghui Pharmaceutical (Hangzhou) Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2024-12-13
Completion
2025-08-15

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 NCT07185282 on ClinicalTrials.gov