A Tolerability Assessment Study of Three Wash Products in Infants

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

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 Overview

• Status: Completed
• Conditions: Skin Care
• Intervention / Treatment: Other: Test shampoo; Other: Test bath foam; Other: Test head to toe wash

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH1 3RH
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Test shampoo; Participants used Oilatum Soothe & Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period.
Experimental: 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.	Other: Test bath foam; 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.
Experimental: 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.	Other: Test head to toe wash; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and day 14

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): April 27, 2015
• Study Completion (Actual): April 27, 2015

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): December 27, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 203080; RH02709 (Other Identifier: GSK)