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

NCT ID: NCT00669071

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-10-31

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.

Detailed Description

Same as above.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IPL / Tri-Luma® Cream

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

IPL/Cetaphil® Moisturizing Cream as Inactive Control

Group Type: ACTIVE_COMPARATOR

Cetaphil® Moisturizing Cream as Inactive Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Tri-Luma® Cream; Cetaphil® Moisturizing Cream

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron W Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

Dermatology/Cosmetic Laser Associates of La Jolla, Inc.

La Jolla, California, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

US10081

Identifier Type: -

Identifier Source: org_study_id