Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
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Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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