Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma

Galderma R&D20 enrolled

Overview

To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melasma

Interventions

Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peelsDRUG

Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects diagnosed with moderate to severe melasma Exclusion Criteria: * Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis) * Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated

Locations (1)

Skin Care Research, Inc.

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

Efficacy - Improvement in Investigator's global assessment of melasma

Time frame: 12 weeks

Secondary Outcomes

Safety - Tolerability assessments and adverse event reporting

Time frame: 12 weeks

Data from ClinicalTrials.gov

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