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
Overview
- Phase
- Phase 2
- Intervention
- SM-030 gel 0.64%
- Conditions
- Melasma
- Sponsor
- DermBiont, Inc.
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Subjects who meet any of the following criteria will be excluded in the study:
- •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.
- •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.
- •Severe photodamage as assessed by the 10-point photo damage assessment scale (Griffiths et al., 1992); (McKenzie et al., 2011).
- •Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).
- •Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.
- •Current or past use of monobenzyl ether to depigment skin.
- •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.
- •Use of the following systemic agents within the specified washout periods:
- •Systemic corticosteroids (28 days)
Arms & Interventions
SM-030 gel 0.64%
Topical application of SM-030 gel 0.64% twice daily for 12 weeks and a 4-week additional safety follow-up period.
Intervention: SM-030 gel 0.64%
Placebo gel
Inactive comparator.
Intervention: Placebo gel
SM-030 gel 0.08%
Topical application of SM-030 gel 0.08% twice daily for 12 weeks and a 4-week additional safety follow-up period.
Intervention: SM-030 gel 0.08%
Outcomes
Primary Outcomes
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations
Time Frame: 12 weeks after first dose
Superiority of SM-030 gel 0.64% over SM-030 gel 0.08% based on proportion of subjects with a lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving SM-030 compared to placebo
Time Frame: 12 weeks after first dose
Superiority of each Active over Placebo based on proportion of subjects with a lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.