Treatment w/ TriLuma® Cream & Intense Pulsed Light vs a Mild Inactive Control Cream & Intense Pulsed Light in Melasma
Information source: Galderma Laboratories, L.P.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melasma
Intervention: Fluocinolone acetonide .01%, hydroquinone 4%, tretinoin .05% (Drug); Inactive Control Cream (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(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
Summary
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.
Clinical Details
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)
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)Degree of pigmentation using a Mexameter at Weeks 6 and 10 (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) 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) Tolerability assessments and incidence of adverse events
Detailed description:
Same as above.
Eligibility
Minimum age: 18 Years.
Maximum age: 74 Years.
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
Locations and Contacts
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
Additional Information
Starting date: December 2007
Ending date: October 2008
Last updated: September 5, 2008
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