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

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 Overview

• Status: Terminated
• Conditions: Melasma
• Intervention / Treatment: Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%; Drug: Cetaphil® Moisturizing Cream as Inactive Control

Detailed Description

Same as above.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Dermatology/Cosmetic Laser Associates of La Jolla, Inc.
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Cetaphil® Moisturizing Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline to week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline to week 6
Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 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.	Baseline to Week 6 and Baseline to Week 10
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement	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	Baseline to week 6
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement	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	Baseline to week 10
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement	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	Baseline to week 6
Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement	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	Baseline to week 10
Number of Participants With Tolerability Assessments Resulting in Adverse Events	Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events	Baseline to week 10

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Ron W Gottschalk, MD, Galderma R&D

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 28, 2008
• First Posted (Estimate): April 29, 2008

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Dermatologic Agents; Keratolytic Agents; Antioxidants; Radiation-Protective Agents; Hydroquinone; Fluocinolone Acetonide; Tretinoin
• Other Study ID Numbers: US10081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No