Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
- Conditions
- Melasma
- Interventions
- Drug: Cetaphil® Moisturizing Cream as Inactive Control
- Registration Number
- NCT00669071
- Lead Sponsor
- Galderma R&D
- 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) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.
- Detailed Description
Same as above.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
- 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.)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IPL / Tri-Luma® Cream Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% - IPL/Cetaphil® Moisturizing Cream as Inactive Control Cetaphil® Moisturizing Cream as Inactive Control -
- Primary Outcome Measures
Name Time Method Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma Baseline to week 10 Number of participants who were a success or failure with regards to melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure
- Secondary Outcome Measures
Name Time Method Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure Baseline to week 6 Number of participants who were a success or failure with regards to melasma severity at Week 6 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure
Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 Baseline to Week 6 and Baseline to Week 10 Degree of pigmentation (melanin) using a Mexameter to record units on a scale at Weeks 6 and 10; units on a scale is a number that represents the presence or absence of melanin in the skin on a scale from 0 - 999 units with 0 units representing no melanin and 999 units representing the maximum amount of melanin.
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement Baseline to week 6 Number of participants showing success or failure in improvement of melasma at Week 6 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement Baseline to week 6 Number of participants showing success or failure in improvement of melasma at Week 6 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement Baseline to week 10 Number of participants showing success or failure in improvement of melasma at Week 10 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement Baseline to week 10 Number of participants showing success or failure in improvement of melasma at Week 10 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure
Number of Participants With Tolerability Assessments Resulting in Adverse Events Baseline to week 10 Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events
Trial Locations
- Locations (2)
Dermatology/Cosmetic Laser Associates of La Jolla, Inc.
🇺🇸La Jolla, California, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States