Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma

Condition(s) targeted: Melasma

Intervention: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

Official title: Open Label Study to Evaluate the Efficacy and Safety of Sequential Therapy With Fluocinolone Acetonide 0.01%, Hydroquinone (HQ) 4% and Tretinoin 0.05% (TriLuma® Cream) and a Series of Glycolic Acid Peels for the Treatment of Melasma

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Efficacy - Improvement in Investigator's global assessment of melasma

Secondary outcome: Safety - Tolerability assessments and adverse event reporting

Detailed description: To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0. 01%, Hydroquinone 4% and Tretinoin 0. 05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects diagnosed with moderate to severe melasma

Exclusion Criteria:

- Subjects under treatment for a dermatologic condition, which may interfere with the

safe evaluation of the study combination (e. g. eczema, psoriasis, severe sun-damage, dermatitis)

- Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be

treated

Skin Care Research, Inc., Boca Raton, Florida 33486, United States

Starting date: November 2006
Ending date: April 2007
Last updated: March 27, 2008