Status:
TERMINATED
Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
Lead Sponsor:
Galderma R&D
Conditions:
Melasma
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
Brief Summary
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)...
Detailed Description
Same as above.
Eligibility Criteria
Inclusion
- 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.)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00669071
Start Date
January 1 2008
End Date
October 1 2008
Last Update
August 23 2022
Active Locations (2)
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1
Dermatology/Cosmetic Laser Associates of La Jolla, Inc.
La Jolla, California, United States, 92037
2
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215