Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma - Full Text View

Sponsored by:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00469183

Purpose

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

Condition	Intervention	Phase
Melasma	Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%	Phase IV

Drug Information available for: Tretinoin 1,4-Benzenediol Fluocinolone Fluocinolone acetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Safety - Skin biopsy evaluation - histological assessment of skin atrophy [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	May 2006
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469183

Locations

United States, California
Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, United States, 90036
United States, Texas
University of Texas Southwestern Medical Center of Dallas
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

Responsible Party:	Galderma laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10010
Study First Received:	May 2, 2007
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00469183
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hyperpigmentation
Skin Diseases
Fluocinolone Acetonide
Pigmentation Disorders

Hydroquinone
Tretinoin
Melanosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009