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

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.

Full Title of Study: “Open Label Study to Evaluate the Efficacy and Safety of Sequential Therapy With Fluocinolone Acetonide 0.01%, Hydroquinone (HQ) 4% and Tretinoin 0.05% (TriLuma® Cream) and a Series of Glycolic Acid Peels for the Treatment of Melasma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2007

Detailed Description

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.

Interventions

  • Drug: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels
    • 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

Arms, Groups and Cohorts

  • Other: 1
    • Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy – Improvement in Investigator’s global assessment of melasma
    • Time Frame: 12 weeks

Secondary Measures

  • Safety – Tolerability assessments and adverse event reporting
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
  • Overall Official(s)
    • Ronald W Gottschalk, MD, Study Director, Galderma R&D

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