Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.

Last updated: June 18, 2018
Sponsor: Stiefel, a GSK Company
Overall Status: Completed

Phase

4

Condition

Allergy

Scalp Disorders

Eczema (Atopic Dermatitis - Pediatric)

Treatment

N/A

Clinical Study ID

NCT01323673
115054
  • Ages > 12
  • All Genders

Study Summary

The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capable of understanding and willing to provide signed informed consent

  • Male or female at least 12 years of age at time of consent and at time of first dose.

  • Able to complete the study and to comply with study instructions.

  • Moderate to severe hand dermatitis.

  • Chronic hand dermatitis diagnosis must be at least 6 months

Exclusion

Exclusion Criteria:

  • Female who is pregnant, trying to become pregnant, or breast feeding.

  • Currently diagnosed with allergic contact dermatitis.

  • Participated in a previous study of the same study product.

  • Had any major illness within 30 days before the screening/baseline visit.

  • Considered immunocompromised.

  • Has a clinically relevant history of or current evidence of abuse of alcohol or otherdrugs.

  • Considered unable or unlikely to attend the necessary visits.

Study Design

Total Participants: 125
Study Start date:
November 15, 2010
Estimated Completion Date:
March 29, 2011

Study Description

Topical corticosteroids have anti-inflammatory, immunosuppressive and antiproliferative properties. Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent corticosteroid combined with moisturizing ingredients in the treatment of corticosteroid responsive dermatoses. The current study is designed to show efficacy and safety in the treatment of moderate to severe chronic hand dermatitis.

Connect with a study center

  • GSK Investigational Site

    San Diego, California 92123
    United States

    Site Not Available

  • GSK Investigational Site

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • GSK Investigational Site

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • GSK Investigational Site

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • GSK Investigational Site

    Montclair, New Jersey 07042
    United States

    Site Not Available

  • GSK Investigational Site

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78759
    United States

    Site Not Available

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