Status:
COMPLETED
Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
Lead Sponsor:
Galderma R&D
Conditions:
Melasma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.
Detailed Description
Same as above.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00469183
Start Date
May 1 2006
End Date
April 1 2007
Last Update
July 29 2022
Active Locations (2)
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1
Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, United States, 90036
2
University of Texas Southwestern Medical Center of Dallas
Dallas, Texas, United States, 75390