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

• Status: Completed
• Trial end date: 2016-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

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