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A Randomized, Observer-Blinded, Placebo-Controlled Study on Safety and Efficacy of SM-030 in Adults With Melasma

Melasma Clinical Trial

Official title:
A Randomized, Observer-Blinded, Placebo-Controlled Study on the Safety and Efficacy of Twice Daily Application of SM-030 Gel 0.64% Vs. SM-030 Gel 0.08% Vs. Placebo Gel in Adults With Melasma

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06454747
Study type Interventional
Source DermBiont, Inc.
Contact Joanna Jay
Phone 510-607-8155
Email joanna.j@dermbiont.com
Status Recruiting
Phase Phase 2
Start date June 6, 2024
Completion date July 2025
View Details
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