Overview
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.
Eligibility
Inclusion Criteria
Subjects must meet all of the following criteria to be included in the study:
- Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma
- Subjects with moderate to severe Melasma using the following guidelines:
- Stable (unchanged per subject reporting) melasma for at least 3 months
- Macular lesions, neither depressed nor atrophic
- Melasma Severity Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin
- Ability to understand, agree to, and sign the study informed consent form (ICF).
- 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
- 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.
- Agree not to change their sun exposure at work, home, or leisure and apply study supplied sunscreen daily.
- Technical ability and willingness to apply Investigational product.
- Willing to allow digital photos of treatment and comparison areas to be taken and stored.
- 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:
- Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma
- Subjects with moderate to severe Melasma using the following guidelines:
- Stable (unchanged per subject reporting) melasma for at least 3 months
- Macular lesions, neither depressed nor atrophic
- Melasma Severity Score of at least 2 (hyperpigmentation at least moderately darker than surrounding normal skin
- Ability to understand, agree to, and sign the study informed consent form (ICF).
- 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
- 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.
- Agree not to change their sun exposure at work, home, or leisure and apply study supplied sunscreen daily.
- Technical ability and willingness to apply Investigational product.
- Willing to allow digital photos of treatment and comparison areas to be taken and stored.
- Willing to apply study-supplied mineral sunscreen, moisturizer, and cleanser to the face daily throughout the duration of the study