Last updated: 11/07/2018 08:31:56

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

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GSK study ID
115054
See study documents
Clinicaltrials.gov ID
NCT01323673
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Trial description: The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of participants with improvement of at least 2 grades in the Investigator's Static Global Assessment (ISGA) (target hand) score from Baseline to Day 15

Timeframe: Baseline (Day 1) and Day 15

Secondary outcomes:

Number of participants with an improvement of at least 1 grade in the ISGA (target hand) score from Baseline to Day 15

Timeframe: Baseline (Day 1) and Day 15

Number of participants with an improvement of at least 2 grades in the ISGA (target hand) score from Baseline to Day 3 and to Day 8

Timeframe: Baseline (Day 1), Day 3, and Day 8

Number of participants with an improvement of at least 1 grade in the ISGA (target hand) score from Baseline to Day 3 and and to Day 8

Timeframe: Baseline (Day 1), Day 3, and Day 8

Number of participants with an ISGA (target hand) score of 0 or 1 at Days 3, 8, and 15

Timeframe: Days 3, 8, and 15

Number of participants with an improvement of at least 1 grade in the Subject Global Assessment (SGA) (target hand) score from Baseline to Days 3, 8, and 15

Timeframe: Baseline (Day 1) and Days 3, 8, and 15

Number of participants with an SGA (target hand) score of 0 or 1 at Days 3, 8, and 15

Timeframe: Days 3, 8, and 15

Percent change from Baseline in pruritus, stinging, burning, and pain scores (target hand) at Days 3, 8, and 15

Timeframe: Baseline (Day 1) and Days 3, 8, and 15

Interventions:
  • Drug: clobetasol propionate 0.05%
  • Drug: Vehicle / Placebo
    • Enrollment:
    125
    Primary completion date:
    2011-29-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Leon Kircik, MD, William J Eastman, MD, Jennifer Gwazdauskas. A randomized, double-blind, phase IV study of the efficacy and safety of clobetasol propionate foam, 0.05% versus vehicle foam in the treatment of chronic hand dermatitis.. J Drugs Dermatol. 2013;12(3):328-34.
    Medical condition
    Dermatitis, Chronic
    Product
    clobetasol
    Collaborators
    GSK
    Study date(s)
    November 2010 to March 2011
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • 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.
    • Female who is pregnant, trying to become pregnant, or breast feeding.
    • Currently diagnosed with allergic contact dermatitis.
    Inclusion and exclusion criteria
    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 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 other drugs.
    • Considered unable or unlikely to attend the necessary visits.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33437
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Montclair, New Jersey, United States, 07042
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40217
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78759
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-29-03
    Actual study completion date
    2011-29-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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