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

NCT07181187 | Active Not Recruiting Phase 2

• 1 other identifier: MH004-E-201
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 24.

  An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

  Baseline; Week 24

Secondary Outcomes (10)

• Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24

  Baseline; Week 24

• Percentage of Participants Achieving a ≥ 50% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24

  Baseline; Week 24

• Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Week 24

  Baseline; Week 24

• Percentage Change from Baseline in Facial Body Surface Area (F-BSA) at Week 24

  Baseline; Week 24

• Percentage Change from Baseline in F-VASI at Week 24

  Baseline; Week 24

Study Arms (6)

VC Period: MH004 1.0% Ointment QD

EXPERIMENTAL

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

Drug: MH004 Ointment

VC Period: MH004 1.0% Ointment BID

EXPERIMENTAL

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

Drug: MH004 Ointment

VC Period: Vehicle Ointment QD

PLACEBO COMPARATOR

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

Drug: Vehicle Ointment

VC Period: Vehicle Ointment BID

PLACEBO COMPARATOR

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

Drug: Vehicle Ointment

LTS Period: 1.0% MH004 Ointment QD

EXPERIMENTAL

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.

Drug: MH004 Ointment

LTS Period: 1.0% MH004 Ointment BID

EXPERIMENTAL

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.

Drug: MH004 Ointment

Interventions

MH004 Ointment 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; LTS Period: 1.0% MH004 Ointment QD; VC Period: MH004 1.0% Ointment BID; VC Period: MH004 1.0% Ointment QD

Vehicle Ointment DRUG

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

VC Period: Vehicle Ointment BID; VC Period: Vehicle Ointment QD

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 12 to 65 years (inclusive) of either gender.
• 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.
• Fully understand the trial content, voluntarily participate in the trial, and sign the ICF.
• Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

You may not qualify if:

• Other dermatoses that may complicate the assessment of vitiligo.
• Previous depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
• Use of protocol-defined treatments within the indicated washout period before baseline.
• Liver or renal damage.
• Allergic to any component of the investigational drug.
• Pregnant or lactating subjects. -

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: March 26, 2024
• Primary Completion: October 14, 2025
• Study Completion (Estimated): May 14, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)