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Randomized Study Using SM-030 Gel for Adults With Melasma

NCT06454747 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-12-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • DermBiont, Inc.

    lead INDUSTRY

Principal Investigators

  • Daivd Zepeda, MD · Zepeda Dermatologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-27
Primary Completion
2025-04-30
Completion
2025-10-31

Countries

  • El Salvador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06454747 on ClinicalTrials.gov