NCT02730819

Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma

An Open-Label Pilot Study Evaluating the Effectiveness and Tolerability of a Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	Illuminate Cream	Topical compound applied daily

Timeline

• Start date: 2016-05-15
• Primary completion: 2016-12-30
• Completion: 2016-12-30
• First posted: 2016-04-07
• Last updated: 2017-10-20
• Results posted: 2017-09-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study