A Tolerability Assessment Study of Three Wash Products in Infants

Not Applicable

Completed

• Conditions: Skin Care
• Interventions: Other: Test shampoo; Other: Test bath foam; Other: Test head to toe wash

• Registration Number: NCT02403999
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-01
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Primary Completion: 2015-04-27
• Study Completion: 2015-04-27
• Results First Submitted: 2017-06-21
• Status Verified: 2017-11
• Results First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Results First Posted: 2018-12-27
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test shampoo	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.
Test bath foam	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.
Test head to toe Wash	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.

Primary Outcome Measures

Name	Time	Method
Tolerability Assessment of Test Products	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 Outcome Measures

Name	Time	Method
Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)	At baseline and day 14	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Edinburgh, United Kingdom