A Tolerability Assessment Study of Three Wash Products in Infants

GlaxoSmithKline32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Skin Care

Interventions

Test shampooOTHER

Participants used Oilatum Soothe \& Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period.

Test bath foamOTHER

Participants used Oilatum Soothe \& Protect Bath Foam at home in place of their usual wash product at least twice weekly for a two week period.

Test head to toe washOTHER

Participants used Oilatum Soothe \& Protect Head to Toe Wash at home in place of their usual wash product at least twice weekly for a two week period.

Eligibility

Sex: ALLMin age: 1 DayMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Edinburgh, United Kingdom

Outcomes

Primary Outcomes

Tolerability Assessment of Test Products

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.

Time frame: At Day 14

Secondary Outcomes

Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)

The changes in participants' skin condition was assessed using the ODS score: where 0= Absent; 1= Faint scaling, faint roughness and dull appearance; 2= Small scales in combination with a few larger scales, slight roughness, whitish appearance; 3= Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks; 4= Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks.

Time frame: At baseline and day 14

Data from ClinicalTrials.gov

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