Evaluating MH004 Ointment for Treating Non-segmental Vitiligo in Adolescents and Adults Ages 12 to 75

What this Trial Is About

Researchers are studying the effects of MH004 ointment on people aged 12 to 75 who have non-segmental vitiligo, a condition that causes loss of skin color. This trial is a randomized, double-blind, placebo-controlled study aiming to assess the ointments safety, effectiveness, and how it behaves in the body. The main goal is to see how many participants achieve a 75% improvement in their facial vitiligo at 24 weeks. Participants will first go through a screening period to confirm eligibility. Then, during the 24-week double-blind treatment phase, they will be randomly assigned to apply either MH004 ointment or a placebo twice daily. Afterward, all participants enter a 28-week extended treatment phase where everyone applies MH004 ointment twice daily. Following treatment, there is a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including measuring changes in the Facial Vitiligo Area Scoring Index and the Total Vitiligo Area Scoring Index at weeks 24 and 52. The study will also monitor any side effects or adverse events. Participants need to comply with scheduled visits, treatment routines, lab tests, and other procedures for the entire duration, which may last over a year including follow-up.

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