Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
Phase 4
Completed
- Conditions
- Melasma
- Interventions
- Registration Number
- NCT00472966
- Lead Sponsor
- Galderma R&D
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels
- Primary Outcome Measures
Name Time Method Efficacy - Improvement in Investigator's global assessment of melasma 12 weeks
- Secondary Outcome Measures
Name Time Method Safety - Tolerability assessments and adverse event reporting 12 weeks
Trial Locations
- Locations (1)
Skin Care Research, Inc.
🇺🇸Boca Raton, Florida, United States