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

Verified by: Galderma Laboratories, L.P., February 2010
First Received: April 24, 2008 | Last Updated: February 4, 2010 | Phase: Phase 4 | Start Date: January 2008
Overall Status: Terminated | Estimated Enrollment: 56
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: October 2008

Detailed Clinical Trial Description

Same as above.

Intervention(s) in this Clinical Trial

  • 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.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: IPL / Tri-Luma® Cream
  • Active Comparator: IPL/Cetaphil® Moisturizing Cream as Inactive Control

Outcome Measures for this Clinical Trial

Primary 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
      Safety Issue?: No

Secondary 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
      Safety Issue?: No
  • Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10
    • Time Frame: Baseline to Week 6 and Baseline to Week 10
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Number of Participants With Tolerability Assessments Resulting in Adverse Events
    • Time Frame: Baseline to week 10
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 74 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Galderma Laboratories, L.P. Industry

Overall Clinical Trial Officials and Contacts

Ron W Gottschalk, MD Study Director Galderma Laboratories, L.P.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669071

Study ID Number: US10081

ClinicalTrials.gov Identifier: NCT00669071

Health Authority: United States: Institutional Review Board

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