Last updated: 11/04/2018 10:10:17

Study to Evaluate Product Duration of Use Experience with Alclometasone Dipropionate Cream

GSK study ID
P2200440
See study documents
Clinicaltrials.gov ID
NCT02075632
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: A Mult-Center, Open-Label Study to Evaluate Product Duration of Use Experience with Aclometasone Diproprionate Cream
Trial description: This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different cohorts: chronic condition sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with incorrect duration of use of the medication

Timeframe: Day1-Day 14

Secondary outcomes:

Number of times per day participants used the product

Timeframe: Day1-Day14

Number of days of use

Timeframe: Day 1-Day 14

Interventions:
  • Drug: Alclometasone dipropionate cream
    • Enrollment:
    310
    Primary completion date:
    2006-30-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Eczema, Allergy symptoms, Psoriasis
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to November 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 65 years
    Accepts healthy volunteers
    No
    • Age: At least 12 years of age.
    • Condition: Currently experiencing itch associated with one of the following skin conditions:
    • Pregnancy: Women who are known to be pregnant (as self-reported) or who are intending to become pregnant over the duration of the study. Women of childbearing potential will be allowed to participate in the study so long as they are practicing a reliable method of contraception (e.g. hormonal birth control such as pill, patch, implant or injection; intrauterine device, double barrier methods, tubal ligation, vasectomized spouse or abstinence).
    • Corticosteroid Use: Subject has used a corticosteroid treatment within two weeks of the screening visit at the start of the study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Age: At least 12 years of age.

      • Condition: Currently experiencing itch associated with one of the following skin conditions:

      • psoriasis or eczema,
      • minor skin conditions such as those caused by poison ivy, oak, or sumac, insect bites, or use of cosmetics, soaps, detergents, or jewelry.
    • Compliance: Subject or subject’s parent or legal guardian understands and is willing, able and likely to comply with all study procedures and restrictions.
    • Consent: Subject or subject’s parent or legal guardian demonstrates ability to read and understand English and is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form (and assent as appropriate).
    Exclusion criteria:
    • Pregnancy: Women who are known to be pregnant (as self-reported) or who are intending to become pregnant over the duration of the study. Women of childbearing potential will be allowed to participate in the study so long as they are practicing a reliable method of contraception (e.g. hormonal birth control such as pill, patch, implant or injection; intrauterine device, double barrier methods, tubal ligation, vasectomized spouse or abstinence).
    • Corticosteroid Use: Subject has used a corticosteroid treatment within two weeks of the screening visit at the start of the study.
    • Breast-feeding: Women who are breastfeeding.
    • Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to alclometasone cream (or closely related compounds), or any of their stated ingredients.
    • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2006-30-11
    Actual study completion date
    2006-30-11

    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

    Additional information
    Not applicable
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