A Clinical Study in Infants to Assess the Tolerability of Three Wash Products

GlaxoSmithKline1 site in 1 country32 target enrollmentMarch 1, 2015

ConditionsSkin Care

Overview

Phase: N/A
Intervention: Not specified
Conditions: Skin Care
Sponsor: GlaxoSmithKline
Enrollment: 32
Locations: 1
Primary Endpoint: Tolerability Assessment of Test Products
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2015

End Date

April 27, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility 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

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.