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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Informed subject consent will be obtained from those patients meeting the following inclusion criteria:
Male and female patients 18 to 65 years age
Moderate to severe melasma, as measured by the Melasma Area Severity Index score greater than or equal to 16
No prior use of topical skin-lightening agents for 1 month prior to study entry
Good general health as confirmed by medical history
Female patients of child-bearing potential with a negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence
Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
Patients who read and sign an approved informed consent for this study

Exclusion Criteria

Vulnerable study population
Exposure to topical skin-lightening agents within 1 month of study entry, including:
1. Topical corticosteroids
2. Topical bleaching products
3. Topical retinoids
Use of systemic preparations within 1 month of study entry, including:
1. Systemic corticosteroids
2. Systemic cyclosporine, interferon
3. Systemic acitretin, etretinate, isotretinoin
4. Systemic methotrexate
5. Systemic photoallergic, phototoxic and/or photosensitizing drugs
UV light therapy and sunbathing
Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function
Pregnant or nursing women
Women planning a pregnancy within the study period

Arm && Interventions

Group	Intervention	Description
Illuminate Cream	Illuminate Cream	Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Melasma Area and Severity Index (MASI) Score	Baseline, 20 weeks	Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on % of the total area involved (A), darkness (D), and homogeneity (H). Scoring for % area involved: 0=none; 1=\<10%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness scoring (hyperpigmentation): 0=normal skin; 1=barely visible; 2=mild; 3=moderate; 4=severe. Homogeneity scoring: 0=normal skin color; 1=specks of involvement; 2=small patchy areas of involvement \<1.5 cm diameter; 3=patches of involvement \>2 cm diameter; 4=uniform skin involvement without any clear areas). To calculate the MASI score, the sum of the severity grade for darkness (D) and homogeneity (H) is multiplied by the numerical value of the areas (A) involved and by the percentages of the four facial areas (10-30%). Total MASI score: Forehead 0.3 (D+H)A + right malar 0.3 (D+H)A + left malar 0.3 (D+H)A + chin 0.1 (D+H)A. The total score can range from 0 (normal) to 48 (severe).

Secondary Outcome Measures

Name	Time	Method
Change in Melasma Quality of Life Scale (MELASQOL)	baseline, 20 weeks	The Melasma Quality of Life Scale has 10 items, with responses ranging from 0 (no response) to 7 (bothered all the time. The range of possible scores is 0-70, with a higher score indicating a worse melasma-related quality of life.
Investigator Assessment of Global Improvement From Baseline	baseline, 20 weeks	The investigator compared the extent of melasma at 20 weeks to a full-face photograph obtained in a standardized manner at baseline. It is a dynamic 7-point scale (0=completely clear to 7=worse).