Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
Information source: Galderma Laboratories, L.P.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melasma
Intervention: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05% (Drug)
Phase: Phase 4
Sponsored by: Galderma Laboratories, L.P.
Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through
Official title: An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Safety - Skin biopsy evaluation - histological assessment of skin atrophy
Secondary outcome: Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment
Same as above.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
Locations and Contacts
Vitiligo and Pigmentation Institute of Southern California, Los Angeles, California 90036, United States
University of Texas Southwestern Medical Center of Dallas, Dallas, Texas 75390, United States
Starting date: May 2006
Ending date: April 2007
Last updated: March 28, 2008