Back to resultsAssessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
Inclusion Criteria:
- Subjects must have a clinical diagnosis of moderate to severe melasma
- Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings,
- Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.
Exclusion Criteria:
- Subjects with diagnosis of dermal melasma
- Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
- Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry
- Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation)
- Subjects with a history of hypertrophic scarring or a history of keloids
- Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study
Sites / Locations
- Vitiligo and Pigmentation Institute of Southern California
- University of Texas Southwestern Medical Center of Dallas
Outcomes
Primary Outcome Measures
Safety - Skin biopsy evaluation - histological assessment of skin atrophy
Secondary Outcome Measures
Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00469183
Brief Title
Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
Official Title
An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
May 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
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.
Detailed Description
Same as above.
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
70 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%
Other Intervention Name(s)
TriLuma Cream
Intervention Description
Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses
Primary Outcome Measure Information:
Title
Safety - Skin biopsy evaluation - histological assessment of skin atrophy
Time Frame
Baseline, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment
Time Frame
Baseline, 12 weeks and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have a clinical diagnosis of moderate to severe melasma
Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings,
Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits.
Exclusion Criteria:
Subjects with diagnosis of dermal melasma
Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry
Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation)
Subjects with a history of hypertrophic scarring or a history of keloids
Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study
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
Vitiligo and Pigmentation Institute of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
University of Texas Southwestern Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20398959
Citation
Grimes PE, Bhawan J, Guevara IL, Colon LE, Johnson LA, Gottschalk RW, Pandya AG. Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma. J Am Acad Dermatol. 2010 Jun;62(6):962-7. doi: 10.1016/j.jaad.2009.06.067. Epub 2010 Apr 15.
Results Reference
derived
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Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
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