NCT06454747

Randomized Study Using SM-030 Gel for Adults With Melasma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: DermBiont, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	SM-030 gel 0.64%	Topical application to face twice daily for 12 weeks.
DRUG	Placebo gel	Topical application to face twice daily for 12 weeks.
DRUG	SM-030 gel 0.08%	Topical application to face twice daily for 12 weeks.

Timeline

• Start date: 2024-06-27
• Primary completion: 2025-04-01
• Completion: 2025-10-01
• First posted: 2024-06-12
• Last updated: 2024-12-13

Locations

2 sites across 1 country: El Salvador