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”

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.

Study Type: Interventional

Study Design: Treatment, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: October 2008

Same as above.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Single arm study

Primary 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
    Safety Issue?: No

Secondary 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
    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
    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
    Safety Issue?: No
• Tolerability assessments and incidence of adverse events
  • Time Frame: 10 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 74 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ron W Gottschalk, MD Study Director Galderma Laboratories, L.P.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669071

Study ID Number: US10081

ClinicalTrials.gov Identifier: NCT00669071

Health Authority: United States: Institutional Review Board