Last updated: 06/18/2019 11:01:13
A tolerability assessment study of three wash products in infants
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2015-27-04
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)
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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