Phase II Clinical Trial of MH004 Ointment in Patients With Non-segmental Vitiligo
Key facts
- Who runs it
- Minghui Pharmaceutical (Hangzhou) Ltd
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 156 people enrolled
- Started
- 26 Mar 2024
- Ended
- 7 May 2026
- Type of study
- Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- MH004 Ointment
- Vehicle Ointment
- Record updated
- 4 June 2026
Who can take part
- Age
- 12 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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; -
Who cannot take part
- 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
- Allergic to any component of the investigational drug
- Other dermatoses that may complicate the assessment of vitiligo
- Liver or renal damage
- Pregnant or lactating subjects. -
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 6 groups in the trial
- VC Period: MH004 1.0% Ointment QDTreatment being tested
Participants received MH004 1.0% Ointment once a day (QD) from Day 1 to Week 24 during the Vehicle Control (VC) Period.
Treatment: MH004 Ointment
- VC Period: MH004 1.0% Ointment BIDTreatment being tested
Participants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 24 during the Vehicle Control (VC) Period.
Treatment: MH004 Ointment
- VC Period: Vehicle Ointment QDPlacebo, for comparison
Participants received vehicle ointment QD from Day 1 to Week 24 during the VC Period.
Treatment: Vehicle Ointment
- VC Period: Vehicle Ointment BIDPlacebo, for comparison
Participants received vehicle ointment BID from Day 1 to Week 24 during the VC Period.
Treatment: Vehicle Ointment
- LTS Period: 1.0% MH004 Ointment QDTreatment being tested
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.
Treatment: MH004 Ointment
- LTS Period: 1.0% MH004 Ointment BIDTreatment being tested
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.
Treatment: MH004 Ointment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 June 2026