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

This study has been completed.
Sponsor:
Information provided by:
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00469183
First received: May 2, 2007
Last updated: March 28, 2008
Last verified: March 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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:
    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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Galderma Laboratories, L.P.

Additional 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
Study First Received: May 2, 2007
Last Updated: March 28, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fluocinolone Acetonide
Hydroquinone
Anti-Inflammatory Agents
Antioxidants
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014