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

NCT00669071 | Terminated Phase 4 Results

• 1 other identifier: US10081
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (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

  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 Outcomes (7)

• 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

  Baseline to week 6

• Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10

  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

  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

  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

  Baseline to week 6

Study Arms (2)

IPL / Tri-Luma® Cream

ACTIVE COMPARATOR

Drug: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%

IPL/Cetaphil® Moisturizing Cream as Inactive Control

ACTIVE COMPARATOR

Drug: Cetaphil® Moisturizing Cream as Inactive Control

Interventions

Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% DRUG

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.

Also known as: Tri-Luma® Cream

IPL / Tri-Luma® Cream

Cetaphil® Moisturizing Cream as Inactive Control DRUG

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.

Also known as: Cetaphil® Moisturizing Cream

IPL/Cetaphil® Moisturizing Cream as Inactive Control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Dermatology/Cosmetic Laser Associates of La Jolla, Inc.

La Jolla, California, 92037, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Melanosis

Interventions

Fluocinolone Acetonide; hydroquinone

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Ronald W. Gottschalk, MD / Medical Director
• Organization: Galderma Laboratories, L.P.

ron.gottschalk@galderma.com

817-961-5358

Study Officials

• Ron W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 23, 2022
• Results First Posted: January 11, 2010

Record last verified: 2012-09

Locations

US (2)