A Clinical Study in Infants to Assess the Tolerability of Three Wash Products
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Tolerability Assessment of Test Products
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 18 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Test shampoo
Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
Intervention: Test shampoo (Other)
Test bath foam
Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
Intervention: Test bath foam (Other)
Test head to toe Wash
Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
Intervention: Test head to toe wash (Other)
Outcomes
Primary Outcomes
Tolerability Assessment of Test Products
Time Frame: At Day 14
The tolerability of the test products under normal conditions of use was assessed by the paediatrician using a 5 point scale: where score 1= very good; 2= good; 3= acceptable; 4= poor and 5= very poor.
Secondary Outcomes
- Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)(At baseline and day 14)