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

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

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.

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.

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. -