Melasma Clinical Trial
Official title:
An Open-Label Pilot Study Evaluating the Effectiveness and Tolerability of a Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma
The purpose of this research study is to gather information on the effectiveness and tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA) approved topical medications for the treatment of moderate to severe melasma.
Subjects with moderate to severe melasma will apply 0.5 grams (pea-sized) amount of
Illuminate Cream topically to affected areas for 20 weeks. The change in Melasma Area and
Severity Index (MASI) score will be evaluated a baseline and Weeks 4, 12, and 20.
The MASI score is a validated test, calculated by subjective assessment of 3 factors: Area
(A) of involvement, Darkness (D), and Homogeneity (H), with the forehead, right malar region,
left malar region, and chin, corresponding to 30%, 30%, 30% and 10% of the total face,
respectively. The area of involvement in each of these 4 areas is given a numeric value of 0
to 6 (0 = no involvement; 1 = <10%; 2 = 10%-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; and 6 =
90-100%).
Darkness and homogeneity are rated on a scale from 0 to 4 (0 = absent; 1 = slight; 2 = mild;
3 = marked; and 4 = maximum). The score is calculated by adding the sum of the severity
ratings for darkness and homogeneity, multiplied by the value of the area of involvement, for
each of the 4 facial areas.
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