Efficacy and Safety of Therapy With Tri-Luma� Cream in Sequence With Glycolic Acid Peels for Melasma
Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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.
Summary
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.
Clinical Details
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: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Eligibility
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
Locations and Contacts
Skin Care Research, Inc., Boca Raton, Florida 33486, United States
Additional Information
Starting date: November 2006
Last updated: March 27, 2008
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