| April 24, 2008 |
| November 6, 2008 |
| December 2007 |
| October 2008 (final data collection date for primary outcome measure) |
| Melasma severity at Week 10 as evaluated using the
Investigator's Global Assessment (IGA) of melasma (IPL/Tri-
Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00669071 on ClinicalTrials.gov Archive Site |
- Melasma severity at Week 6 as evaluated using the Investigator's Global Assessment of melasma (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Degree of pigmentation using a Mexameter at Weeks 6 and 10 (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
- Improvement in melasma at Weeks 6 and 10 as evaluated using the Investigator's and Subject's evaluation of improvement (IPL/Tri-Luma® Cream side vs. IPL/Inactive Control Cream side) [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
- Tolerability assessments and incidence of adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Treatment w/ TriLuma® Cream & Intense Pulsed Light vs a Mild Inactive Control Cream & Intense Pulsed Light in Melasma |
| Split-Face, Randomized, Open-Label Study of Sequential Treatment With Tri-Luma® Cream With Intense Pulsed Light vs. a Mild Inactive Control Cream With Intense Pulsed Light in Subjects With Melasma |
This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%); TLC) 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. |
Same as above. |
| Phase IV |
| Interventional |
| Treatment, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study |
| Melasma |
- Drug: Fluocinolone acetonide .01%, hydroquinone 4%, tretinoin .05%
- Drug: Inactive Control Cream
|
| Other: Single arm study |
| |
| |
| Terminated |
| 56 |
| October 2008 |
| October 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects diagnosed with moderate to severe melasma on both sides of the face (IGA at baseline must be 3 or 4.)
Exclusion Criteria:
- Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated
- Subjects with prior facial 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
|
| Both |
| 18 Years to 74 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00669071 |
| Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P. |
| US10081 |
| Galderma Laboratories, L.P. |
|
| Study Director: |
Ron W Gottschalk, MD |
Galderma Laboratories, L.P. |
|
|
| Galderma Laboratories, L.P. |
| November 2008 |
