Clinical trial NCT00669071: Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma
Official title: Split-Face, Randomized, Open-Label Study of Sequential Treatment With Tri-Luma® Cream With Intense Pulsed Light (IPL) vs. a Mild Inactive Control Cream With Intense Pulsed Light (IPL) in Subjects With Melasma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Melasma
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Baseline to week 10
Secondary outcomes:
measure: 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
timeFrame: Baseline to week 6
measure: Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10
timeFrame: Baseline to Week 6 and Baseline to Week 10
measure: Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement
timeFrame: Baseline to week 6
measure: Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement
timeFrame: Baseline to week 10
measure: Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement
timeFrame: Baseline to week 6
measure: Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement
timeFrame: Baseline to week 10
measure: Number of Participants With Tolerability Assessments Resulting in Adverse Events
timeFrame: Baseline to week 10
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Dermatology/Cosmetic Laser Associates of La Jolla, Inc.
state: California
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
Study officials:
affiliation: Galderma R&D
name: Ron W Gottschalk, MD
role: STUDY_DIRECTOR
References: