Santa Tecla

Researchers are evaluating the safety and efficacy of two different strengths of SM-030 gel compared to a placebo gel in adults diagnosed with Melasma, a skin condition causing dark patches. This phase 2b randomized, observer-blinded study includes healthy male and female participants with moderate to severe Melasma and Fitzpatrick skin types II through V. The study aims to understand how well the gel improves skin appearance over a 12-week treatment period. Participants will be assigned to one of three groups SM-030 gel 0.64%, SM-030 gel 0.08%, or a placebo gel. Each participant will apply their assigned gel topically to the face twice daily for 12 weeks. Following this treatment period, there is a 4-week safety follow-up to monitor any side effects or changes. During the study, participants will visit the study sites regularly for safety and effectiveness assessments, including digital photos of the treatment areas. Researchers will measure changes in skin improvement using the Investigator Assessment of Global Improvement after 12 weeks. Participants will also apply study-supplied mineral sunscreen, moisturizer, and cleanser daily, and adherence to treatment and sun protection will be monitored throughout the study lasting approximately 16 weeks.