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Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma

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ClinicalTrials.gov Identifier: NCT00669071
Recruitment Status : Terminated (Enrollment closed)
First Posted : April 29, 2008
Results First Posted : January 11, 2010
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melasma Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% Drug: Cetaphil® Moisturizing Cream as Inactive Control Phase 4

Detailed Description:
Same as above.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: IPL / Tri-Luma® Cream Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
Other Name: Tri-Luma® Cream
Active Comparator: IPL/Cetaphil® Moisturizing Cream as Inactive Control Drug: Cetaphil® Moisturizing Cream as Inactive Control
Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
Other Name: Cetaphil® Moisturizing Cream


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. 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 [ Time Frame: 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

  2. Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10 [ Time Frame: 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.

  3. Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement [ Time Frame: 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

  4. Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement [ Time Frame: 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

  5. Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement [ Time Frame: 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

  6. Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement [ Time Frame: 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

  7. Number of Participants With Tolerability Assessments Resulting in Adverse Events [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669071


Locations
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United States, California
Dermatology/Cosmetic Laser Associates of La Jolla, Inc.
LaJolla, California, United States, 92037
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Study Director: Ron W Gottschalk, MD Galderma Laboratories, L.P.
More Information
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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00669071    
Other Study ID Numbers: US10081
First Posted: April 29, 2008    Key Record Dates
Results First Posted: January 11, 2010
Last Update Posted: October 2, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Fluocinolone Acetonide
Tretinoin
Hydroquinone
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiation-Protective Agents