Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma

An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma

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