Back to resultsEfficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility 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
Sites / Locations
- Skin Care Research, Inc.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels
Outcomes
Primary Outcome Measures
Efficacy - Improvement in Investigator's global assessment of melasma
Secondary Outcome Measures
Safety - Tolerability assessments and adverse event reporting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00472966
Brief Title
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
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 Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels
Intervention Type
Drug
Intervention Name(s)
Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels
Other Intervention Name(s)
Tri-Luma® Cream, NeoStrata® Glycolic Acid Skin Renewal Peel
Intervention Description
Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10
Primary Outcome Measure Information:
Title
Efficacy - Improvement in Investigator's global assessment of melasma
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety - Tolerability assessments and adverse event reporting
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Skin Care Research, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
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