Condition(s) treated: Melasma

Intervention: Fluocinolone acetonide .01%, hydroquinone 4%, tretinoin .05% (Drug); Inactive Control Cream (Drug)

Phase: Phase 4

Enrollment status: Recruiting

Sponsor: Galderma Laboratories, L.P.

Principal investigator(s) or official(s):
Ron W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

Overall contact:
Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com

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.

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

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

Primary outcome: 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)

Secondary outcome:
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)

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)

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)

Tolerability assessments and incidence of adverse events (Time Frame: 10 weeks)

Detailed description: Same as above.

Minimum eligible age: 18 Years. Maximum eligible age: 74 Years. Eligible gender(s): Both.

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

Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com

Dermatology/Cosmetic Laser Associates of La Jolla, Inc., LaJolla, California 92037, United States; Recruiting
Dawn Faringhy, Phone: 858-459-7013, Email: dfaringhy@spa-md.com
Mitchel P Goldman, MD, Principal Investigator

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States; Recruiting
Tammy Lewis-Burgan, LPN, Phone: 615-383-9660, Ext: 173, Email: tlewis-burgan@goldskincare.com
Michael Gold, MD, Principal Investigator

Start date: December 2007
End date: September 2008
Last updated: April 28, 2008

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