combination alexandrite laser and topical therapy vs topical therapy alone for treatment of melasma

Conditions: Melasma

Summary: the purpose of this study is to evaluate the efficacy and safety of a combination of non-hydroquinone topical therapy and a 755nm alexandrite compared to topical therapy alone for the treatment of facial melasma.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18-74 years of age; * fitzpatrick skin types i-iv; * female subjects of childbearing potential must have a negative urine pregnancy test at the beginning of the study, and agree to practice appropriate birth-control to prevent pregnancy during the study. the type and dose of birth control must have been stable for at least 3 months prior to study entry and it is not expected to change during the study; acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants norplant®, depo-provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active. * subjects diagnosed with moderate to severe melasma on both sides of the face * for subjects using medication to treat a concurrent medical condition, type and dose must have been stable for at least 3 months prior to study entry and it is not expected to change during the study (except any medications specifically outlined in the exclusion criteria section) * subjects able to avoid prolonged sun exposure on the face for the duration of the study and willing to use appropriate sun avoidance techniques. * subjects able to follow study instructions and likely to complete all required visits; * subjects/representative able and willing to sign the informed consent (which includes a photography release) prior to any study procedures. exclusion criteria: * female subjects who are pregnant, nursing or planning a pregnancy during the course of the study; * subjects with a condition or who are in a situation which, in the investigator's opinion, may put the subject at risk, may confound the study results, or may interfere with the subject's participation in the study, such as: the use of a concomitant medication that can interfere with the study or worsen any condition when used during the study, the use of medications known to induce photosensitivity; * subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study regimen (e.g. eczema, psoriasis, severe sun-damage, dermatitis) and/or have scarring or infection of the area to be treated; * subjects with a diagnosis of skin cancer (bce, scc, melanoma, etc.) in the areas to be treated; * subject unwilling to avoid any other treatment for melasma during the study (total duration of 30 weeks); * subjects with a wash-out period of less than 14 days for melasma treatments at the time of study entry or under current treatment; * subjects with prior facial resurfacing, deep or chemical peels within 6 months of the date of study entry; * subject unwilling to refrain from any facial cosmetic procedures during the study period (e.g., chemical peels, resurfacing, microdermabrasion, etc.); * subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study; * subject has participated in a clinical research study within the last 30 days prior to enrollment; * subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or other reasons; * subject is unable to meet the study attendance requirements.