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

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.

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