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Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00469183
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : March 31, 2008
Information provided by:
Galderma Laboratories, L.P.

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

Condition or disease Intervention/treatment Phase
Melasma Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05% Phase 4

Detailed Description:
Same as above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma
Study Start Date : May 2006
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Intervention Details:
    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
    Other Name: TriLuma Cream

Primary Outcome Measures :
  1. Safety - Skin biopsy evaluation - histological assessment of skin atrophy [ Time Frame: Baseline, 12 weeks and 24 weeks ]

Secondary Outcome Measures :
  1. Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment [ Time Frame: Baseline, 12 weeks and 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469183

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00469183     History of Changes
Other Study ID Numbers: US10010
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Fluocinolone Acetonide
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiation-Protective Agents