Randomized Study Using SM-030 Gel for Adults With Melasma (NCT06454747) | Clinical Trial Compass
RecruitingPhase 2
Randomized Study Using SM-030 Gel for Adults With Melasma
El Salvador138 participantsStarted 2024-06-27
Plain-language 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.
Who can participate
Age range18 Years ā 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Subjects must meet all of the following criteria to be included in the study:
ā. Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma
ā. Subjects with moderate to severe Melasma using the following guidelines:
Exclusion criteria
ā. Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study.
ā. Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to vitiligo affecting the treatment and comparison sites.
ā. Severe photodamage as assessed by the 10-point photo damage assessment scale (Griffiths et al., 1992); (McKenzie et al., 2011).
ā. Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).
ā. Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.
What they're measuring
1
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving SM-030 compared to placebo
Timeframe: 12 weeks after first dose
2
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations
ā. Current or past use of monobenzyl ether to depigment skin.
ā. Use of the following topical preparations within a 28-day washout period: topical corticosteroids, topical bleaching products (hyroquinone, niacinamide, kojic acid, ascorbic acid, chemical peels, topical tranexamic acid (TXA)), UV light therapy and sunbathing, topical retinoids.
ā. Use of the following systemic agents within the specified washout periods: