Status:
ACTIVE_NOT_RECRUITING
Phase II Clinical Trial of MH004 Ointment in Patients With Non-segmental Vitiligo
Lead Sponsor:
Minghui Pharmaceutical (Hangzhou) Ltd
Conditions:
Vitiligo
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
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...
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 Ointm...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- 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. -
Key Trial Info
Start Date :
March 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT07181187
Start Date
March 26 2024
End Date
May 14 2026
Last Update
September 18 2025
Active Locations (1)
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1
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China