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

NCT ID: NCT07181187

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2026-05-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VC Period: MH004 1.0% Ointment QD

Participants received MH004 1.0% Ointment once a day (QD) from Day 1 to Week 24 during the Vehicle Control (VC) Period.

Group Type: EXPERIMENTAL

MH004 Ointment

Intervention Type: DRUG

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

VC Period: MH004 1.0% Ointment BID

Participants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 24 during the Vehicle Control (VC) Period.

Group Type: EXPERIMENTAL

MH004 Ointment

Intervention Type: DRUG

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

VC Period: Vehicle Ointment QD

Participants received vehicle ointment QD from Day 1 to Week 24 during the VC Period.

Group Type: PLACEBO_COMPARATOR

Vehicle Ointment

Intervention Type: DRUG

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

VC Period: Vehicle Ointment BID

Participants received vehicle ointment BID from Day 1 to Week 24 during the VC Period.

Group Type: PLACEBO_COMPARATOR

Vehicle Ointment

Intervention Type: DRUG

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

LTS Period: 1.0% MH004 Ointment QD

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment QD will apply MH004 1.0% Ointment QD from week 24 to week 52 during the LTS period.

Group Type: EXPERIMENTAL

MH004 Ointment

Intervention Type: DRUG

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

LTS Period: 1.0% MH004 Ointment BID

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment BID will apply MH004 1.0% Ointment BID from week 24 to week 52 during the LTS period.

Group Type: EXPERIMENTAL

MH004 Ointment

Intervention Type: DRUG

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

Interventions

MH004 Ointment

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

Intervention Type: DRUG

Vehicle Ointment

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients aged 12 to 65 years (inclusive) of either gender.

2. Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face and total body vitiligo area not exceeding 20% BSA.

3. Fully understand the trial content, voluntarily participate in the trial, and sign the ICF.

4. Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

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Exclusion Criteria

1. Other dermatoses that may complicate the assessment of vitiligo.

2. Previous depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.

3. Use of protocol-defined treatments within the indicated washout period before baseline.

4. Liver or renal damage.

5. Allergic to any component of the investigational drug.

6. Pregnant or lactating subjects. -

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minghui Pharmaceutical (Hangzhou) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

MH004-E-201

Identifier Type: -

Identifier Source: org_study_id