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

CT-214

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.

2024-06-06

2025-01-01

2025-07-01

Recruiting

Early phase I

138

Inclusion Criteria Subjects must meet all of the following criteria to be included in the study: 1. Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma 2. Subjects with moderate to severe Melasma using the following guidelines: 1. Stable (unchanged per subject reporting) melasma for at least 3 months 2. Macular lesions, neither depressed nor atrophic 3. Melasma Severity Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin 3. Ability to understand, agree to, and sign the study informed consent form (ICF). 4. For female or childbearing subjects, they must be on an agreeable form of birth control (oral contraceptive therapies, estrogen replacement therapies, other non-oral hormonal therapies, IUDs, be abstinent, or have a vasectomized partner) and who have not added and/or changed the method of birth control in the last 6 months, and have no intention of adjusting or changing the method of birth control 5. Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted. 6. Agree not to change their sun exposure at work, home, or leisure and apply study supplied sunscreen daily. 7. Technical ability and willingness to apply Investigational product. 8. Willing to allow digital photos of treatment and comparison areas to be taken and stored. 9. Willing to apply study-supplied mineral sunscreen, moisturizer, and cleanser to the face daily throughout the duration of the study Exclusion Criteria: Subjects must meet all of the following criteria to be included in the study: 1. Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma 2. Subjects with moderate to severe Melasma using the following guidelines: 1. Stable (unchanged per subject reporting) melasma for at least 3 months 2. Macular lesions, neither depressed nor atrophic 3. Melasma Severity Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin 3. Ability to understand, agree to, and sign the study informed consent form (ICF). 4. For female or childbearing subjects, they must be on an agreeable form of birth control (oral contraceptive therapies, estrogen replacement therapies, other non-oral hormonal therapies, IUDs, be abstinent, or have a vasectomized partner) and who have not added and/or changed the method of birth control in the last 6 months, and have no intention of adjusting or changing the method of birth control 5. Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted. 6. Agree not to change their sun exposure at work, home, or leisure and apply study supplied sunscreen daily. 7. Technical ability and willingness to apply Investigational product. 8. Willing to allow digital photos of treatment and comparison areas to be taken and stored. 9. Willing to apply study-supplied mineral sunscreen, moisturizer, and cleanser to the face daily throughout the duration of the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized 3-arm tranche of main cohorts', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 138, 'type': 'ESTIMATED'}}

2024-06-12