A Phase III Clinical Study to Evaluate the Efficacy and Safety of MH004 Ointment in Non-segmental Vitiligo

Inclusion criteria

• . Subjects aged 12 to 75 years inclusive at the time of signing the Informed Consent Form (ICF), with no restriction on gender.
• . Clinically diagnosed with non-segmental vitiligo.
• . Prior to study drug administration, participants with vitiligo shall meet the following criteria regarding vitiligo lesion area: Facial lesion area ≥ 0.3% body surface area (BSA), and Facial Vitiligo Area Scoring Index (F-VASI) score ≥ 0.3.
• . Agree to discontinue all vitiligo therapeutic medications and interventions from the time of ICF signature until the end of the last study visit. Over-the-counter (OTC) drugs shall not exert therapeutic effects on vitiligo or interfere with skin pigmentation, including corticosteroids and other immunomodulators. Final eligibility of such OTC drugs shall be determined by the Investigator. Camouflaging makeup is permitted.
• . Women of Childbearing Potential (WOCBP) and male participants whose partners are WOCBP must agree to use reliable contraceptive methods throughout the trial period and for 28 days after the last study drug administration (abstinence, prior sterilization, oral contraceptives, and/or barrier methods \[condoms, diaphragms, cervical caps, etc.\]). For WOCBP, the human chorionic gonadotropin (hCG) pregnancy test result at the screening visit and prior to the first drug administration at the baseline visit must be negative. Male participants shall not donate sperm during the trial and for 3 months after study completion or drug discontinuation.
• . The participant and/or their legal guardian shall fully understand the trial content, requirements and procedures, voluntarily participate in this clinical trial and sign the ICF, and be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other study procedures throughout the trial.