Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.

Same as above.

Inclusion Criteria:

• Subjects must have a clinical diagnosis of moderate to severe melasma
• Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings,
• Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.

Exclusion Criteria:

• Subjects with diagnosis of dermal melasma
• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
• Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry
• Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation)
• Subjects with a history of hypertrophic scarring or a history of keloids
• Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study