Treatment w/ TriLuma® Cream & Intense Pulsed Light vs a Mild Inactive Control Cream & Intense Pulsed Light in Melasma - Full Text View

Sponsored by:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00669071

Purpose

This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%); TLC) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.

Condition	Intervention	Phase
Melasma	Drug: Fluocinolone acetonide .01%, hydroquinone 4%, tretinoin .05% Drug: Inactive Control Cream	Phase IV

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Split-Face, Randomized, Open-Label Study of Sequential Treatment With Tri-Luma® Cream With Intense Pulsed Light vs. a Mild Inactive Control Cream With Intense Pulsed Light in Subjects With Melasma

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

Primary Outcome Measures:

Melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (IPL/Tri- Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Melasma severity at Week 6 as evaluated using the Investigator's Global Assessment of melasma (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Degree of pigmentation using a Mexameter at Weeks 6 and 10 (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
Improvement in melasma at Weeks 6 and 10 as evaluated using the Investigator's and Subject's evaluation of improvement (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
Tolerability assessments and incidence of adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	56
Study Start Date:	December 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Single arm study	Drug: Fluocinolone acetonide .01%, hydroquinone 4%, tretinoin .05% Applied once daily at bedtime on one side of the face Drug: Inactive Control Cream Applied once daily at bedtime on the opposite side of the face

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects diagnosed with moderate to severe melasma on both sides of the face (IGA at baseline must be 3 or 4.)

Exclusion Criteria:

Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated
Subjects with prior facial IPL, resurfacing, deep or chemical peels within 6 months of the date of study entry
Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669071

Locations

United States, California
Dermatology/Cosmetic Laser Associates of La Jolla, Inc.
LaJolla, California, United States, 92037
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ron W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10081
Study First Received:	April 24, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00669071
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hyperpigmentation
Skin Diseases
Facies
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