Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.
Same as above.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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
Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, United States
University of Texas Southwestern Medical Center of Dallas
Dallas, Texas, United States
Safety - Skin biopsy evaluation - histological assessment of skin atrophy
Time frame: Baseline, 12 weeks and 24 weeks
Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment
Time frame: Baseline, 12 weeks and 24 weeks
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