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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma Laboratories, L.P.
• Treatments: Fluocinolone Acetonide; Hydroquinone; Tretinoin

Criteria

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