Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma - Full Text View

Sponsor:	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%) 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 0.01%, hydroquinone 4%, tretinoin 0.05% Drug: Cetaphil® Moisturizing Cream as Inactive Control	Phase IV

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

Resource links provided by NLM:

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

U.S. FDA Resources

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

Primary Outcome Measures:

Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 [ Time Frame: Baseline to Week 6 and Baseline to Week 10 ] [ Designated as safety issue: No ]
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: No ]
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: No ]
Number of Participants With Tolerability Assessments Resulting in Adverse Events [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
Active Comparator: IPL / Tri-Luma® Cream	Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face. Other Name: Tri-Luma® Cream
Active Comparator: IPL/Cetaphil® Moisturizing Cream as Inactive Control	Drug: Cetaphil® Moisturizing Cream as Inactive Control Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face. Other Name: Cetaphil® Moisturizing Cream

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 (Investigator's Global Assessment (IGA) at baseline must be 3 or 4.)

Exclusion Criteria:

Subjects with a diagnosis of skin cancer (Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Melanoma) in the areas to be treated
Subjects with prior facial Intense Pulsed Light (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

No publications provided

Responsible Party:	Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00669071 History of Changes
Other Study ID Numbers:	US10081
Study First Received:	April 24, 2008
Results First Received:	September 25, 2009
Last Updated:	February 4, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Fluocinolone Acetonide
Hydroquinone
Tretinoin
Emollients
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012