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

Stopped early · Phase 4

Conditions studied: Melasma

In brief

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.

Key facts

Study ID

NCT00669071

Run by

Galderma R&D

People needed

56

Starts

2008-01-01

Expected to finish

2008-10-01

Last updated by the study team

2022-08-23

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• Dermatology/Cosmetic Laser Associates of La Jolla, Inc. — La Jolla, California, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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