Last updated: 11/03/2018 22:22:28

A Pilot Study to Assess Itchy, Dry Skin in Healthy Subjects

GSK study ID
202340
See study documents
Clinicaltrials.gov ID
Not applicable
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 Pilot Study to Assess Itchy, Dry Skin in Healthy Subjects
Trial description: This will be a randomized, two-product parallel-group, examiner-blind pilot study which will assess relief from itchy, dry skin in healthy adults. Itch relief and intensity (associated with dry skin) will be assessed on two different scales.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Assessment of relief from itchy and dry skin

Timeframe: From baseline to 8 hours

Assessment of intensity of itchy and dry skin

Timeframe: From baseline to 8 hours

Secondary outcomes:
Not applicable
Interventions:
  • Other: Test cream
  • Other: Reference cream
    • Enrollment:
    63
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Skin Care
    Product
    GSK1507202, GSK2695294, GSK2695982
    Collaborators
    TKL Research Inc.
    Study date(s)
    October 2014 to November 2014
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 85 Year
    Accepts healthy volunteers
    yes
    • Participant demonstrating understanding of the study and willingness to participate
    • Aged 18 to 85 years at the time of consent
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participant demonstrating understanding of the study and willingness to participate
    • Aged 18 to 85 years at the time of consent
    • Understands and is willing, able and likely to comply with all study procedures and restrictions
    • Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities in medical history or upon physical examination. b) Absence of any condition that could affect the subject’s safety or well being or their ability to understand and follow study procedures and requirements
    • Participant has itchy, dry skin that prompts moisturizer use
    Exclusion criteria:
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
    • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
    • Recent history (within the last year) of alcohol or other substance abuse
    • Use of oral corticosteroids or immunosuppressive medications within 4 weeks or topical corticosteroids, anti-histamines or within 2 weeks of visit 1
    • Current use of any medication, that in the opinion of the investigator, will affect study assessments
    • Clinically significant chronic or acute concurrent illnesses (e.g. psoriasis, atopic dermatitis in active flare etc.) that, in the opinion of the Investigator, may interfere with the study assessments
    • An employee of the sponsor or the study site or members of their immediate family
    • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
    • Previous participation in this study

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-14-11

    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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