Randomized Study Using SM-030 Gel for Adults With Melasma
ConditionMelasma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDermBiont, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical diagnosis of Melasma
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
SM-030 gel 0.64%
DrugTopical application to face twice daily for 12 weeks.
Placebo gel
DrugTopical application to face twice daily for 12 weeks.
SM-030 gel 0.08%
DrugTopical application to face twice daily for 12 weeks.
Treatment groups
138 Participants
are divided into 3 treatment groupsGroup A: SM-030 gel 0.64%Experimental treatment 1 intervention
Group B: Placebo gelPlacebo comparator 1 intervention
Group C: SM-030 gel 0.08%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving SM-030 compared to placebo
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.
Time frame
12 weeks after first dose2
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations
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.
Time frame
12 weeks after first doseSponsors and contacts
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Source ClinicalTrials.gov