Active — Not RecruitingPhase 2

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

China156 participantsStarted 2024-03-26

Plain-language 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.

Who can participate

Age range12 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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. -

What they're measuring

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

Timeframe: Baseline; Week 24

Trial details

NCT IDNCT07181187

SponsorMinghui Pharmaceutical (Hangzhou) Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-14

View on ClinicalTrials.gov More Vitiligo trials