Official Title: “An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: April 2007

Same as above.

Intervention(s) in this Clinical Trial

• Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%
  • 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

Primary Measures

• Safety - Skin biopsy evaluation - histological assessment of skin atrophy
  • Time Frame: Baseline, 12 weeks and 24 weeks
    Safety Issue?: Yes

Secondary Measures

• Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment
  • Time Frame: Baseline, 12 weeks and 24 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, L.P.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469183

Study ID Number: US10010

ClinicalTrials.gov Identifier: NCT00469183

Health Authority: United States: Institutional Review Board