Last updated: 06/18/2019 11:01:13

A tolerability assessment study of three wash products in infants

GSK study ID
203080
See study documents
Clinicaltrials.gov ID
NCT02403999
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 Clinical Study in Infants to Assess the Tolerability of Three Wash Products
Trial description: This will be a single centre, evaluator blind, randomized, parallel group, stratified, two week study in healthy participants. The clinical study is designed to provide reassurance that the formulations developed for children and babies with mild to moderately dry skin and for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the target population, babies and young children with dry skin.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Tolerability assessment of test products

Timeframe: At Day 14

Secondary outcomes:

Change from baseline in Overall Dry Skin [ODS] score at Day 14 (Visual assessment of skin)

Timeframe: At baseline and day 14

Interventions:
  • Other: Test shampoo
  • Other: Test bath foam
  • Other: Test head to toe wash
    • Enrollment:
    32
    Primary completion date:
    2015-27-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Skin Care
    Product
    GSK3562391, GSK3776553, GSK3776554
    Collaborators
    TKL Research Inc.
    Study date(s)
    March 2015 to April 2015
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    1 days - 18 months
    Accepts healthy volunteers
    Yes
    • Participants up to 18 months of age at the screening/baseline visit with good general health and no major physical disabilities
    • Parent/legal guardian reported dry skin
    • Allergy/intolerance or hypersensitivity to the study material or any of their stated ingredients
    • Participant with skin condition that warrants medical intervention, current episode of eczema/atopic dermatitis or has had an episode in the 3 months prior to screening, not regular use of moisturizers (variable application frequency)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants up to 18 months of age at the screening/baseline visit with good general health and no major physical disabilities
    • Parent/legal guardian reported dry skin
    • Voluntary written informed consent form by parent/legal guardian as an evidence to understanding of the study and willingness to participate
    Exclusion criteria:
    • Allergy/intolerance or hypersensitivity to the study material or any of their stated ingredients
    • Participant with skin condition that warrants medical intervention, current episode of eczema/atopic dermatitis or has had an episode in the 3 months prior to screening, not regular use of moisturizers (variable application frequency)
    • Use of oral corticosteroids/immunosuppressive medication within 4 weeks or topical corticosteroids/topical anti-itch products within 2 weeks of baseline
    • Child in Care; participants' previous participation in this study/another clinical study/receipt of investigational drug within 30 days of the screening visit
    • Parent/legal guardian aged 18 years or under, employee of the sponsor or the study site or members of their immediate family
    • Participant living in the same household of an already enrolled participant

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Edinburgh, United Kingdom, EH1 3RH
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    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
    2015-27-04
    Actual study completion date
    2015-27-04

    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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