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

This study has been terminated.
(Enrollment closed)
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00669071
First received: April 24, 2008
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 6 and Baseline to Week 10 ] [ Designated as safety issue: No ]
    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 Investigator's Evaluation of Improvement [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: No ]
    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 6 Using the Subject's Evaluation of Improvement [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
    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 10 Using the Subject's Evaluation of Improvement [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 10 ] [ Designated as safety issue: Yes ]
    Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events


Enrollment: 56
Study Start Date: January 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Same as above.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669071

Locations
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
Study Director: Ron W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00669071     History of Changes
Other Study ID Numbers: US10081
Study First Received: April 24, 2008
Results First Received: September 25, 2009
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fluocinolone Acetonide
Hydroquinone
Emollients
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiation-Protective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 18, 2014