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OpenTrials
Completed

NCT Number: NCT00472966

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

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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Tri-Luma® Cream, NeoStrata® Glycolic Acid Skin Renewal Peel

Primary outcomes

  1. Efficacy - Improvement in Investigator's global assessment of melasma

    Time frame: 12 weeks

Secondary outcomes

  1. Safety - Tolerability assessments and adverse event reporting

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 14, 2007
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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