Condition: Melasma · Sponsor: DermBiont, Inc.
Brief Summary This is a phase 2b, observer-blinded, randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 0.64% and SM-030 gel 0.08% compared against placebo gel in healthy adult male and female subjects with Melasma. The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period. Approximately 138 subjects who meet the eligibility criteria, notably with a clinical diagnosis of Melasma will be randomized in a 3:2:1 ratio to one of three treatment arms: SM-030 gel 0.64% (N=69), Placebo gel (N=46), or SM-030 gel 0.08% (N=23). Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites (4 sites in Mexico and 1 in El Salvador). Subjects will be assessed for safety and efficacy at each visit.
This description comes directly from the study's public registry record.
Joanna Jay · 510-607-8155 · joanna.j@dermbiont.com
Emma Taylor · 510-607-8155 · Emma@Dermbiont.com
Always discuss trial participation with your own doctor first.
| Zepeda Dermatologia | Santa Tecla, La Libertad Department, El Salvador | Recruiting |
| Centro de Investigación y Desarrollo Brioso Ramirez | Santa Tecla, La Libertad, El Salvador, El Salvador | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06454747