Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Intervention: Illuminate Cream
Intervention description: Topical compound applied daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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