NCT02403999

A Tolerability Assessment Study of Three Wash Products in Infants

Completed NA Results posted Last updated 27 December 2018

What this trial tests

NA trial testing Test shampoo in Skin Care in 32 participants. Completed in 27 April 2015.

Timeline

1 March 2015

Primary endpoint
27 April 2015

27 April 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	32
Start date	1 March 2015
Primary completion	27 April 2015
Estimated completion	27 April 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• Test shampoo
• Test bath foam
• Test head to toe wash

Conditions studied

• Skin Care — all drugs for Skin Care →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 1 Day to 18 Months, any sex, with Skin Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tolerability Assessment of Test Products Primary · 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.

Overall

Group	Value	95% CI
Test Shampoo	9
Test Bath Foam	10
Test Head to Toe Wash	11
Test Shampoo	1
Test Bath Foam	0
Test Head to Toe Wash	0
Test Shampoo	0
Test Bath Foam	0
Test Head to Toe Wash	0
Test Shampoo	0
Test Bath Foam	0
Test Head to Toe Wash	0

Age stratum <12 months

Group	Value	95% CI
Test Shampoo	5
Test Bath Foam	5
Test Head to Toe Wash	6
Test Shampoo	0
Test Bath Foam	0
Test Head to Toe Wash	0
Test Shampoo	0
Test Bath Foam	0
Test Head to Toe Wash	0
Test Shampoo	0
Test Bath Foam	0
Test Head to Toe Wash	0

Age stratum ≥12 months

Group	Value	95% CI
Test Shampoo	4
Test Bath Foam	5
Test Head to Toe Wash	5
Test Shampoo	1
Test Bath Foam	0
Test Head to Toe Wash	0
Test Shampoo	0
Test Bath Foam	0
Test Head to Toe Wash	0
Test Shampoo	0
Test Bath Foam	0
Test Head to Toe Wash	0

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

Overall

Group	Value	95% CI
Test Shampoo	-1.2	± 0.79
Test Bath Foam	-0.9	± 0.57
Test Head to Toe Wash	-0.5	± 0.69

Age Stratum <12 months

Group	Value	95% CI
Test Shampoo	-0.8	± 0.84
Test Bath Foam	-1.0	± 0.71
Test Head to Toe Wash	-0.7	± 0.52

Age Stratum ≥12 months

Group	Value	95% CI
Test Shampoo	-1.6	± 0.55
Test Bath Foam	-0.8	± 0.45
Test Head to Toe Wash	-0.4	± 0.89

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 14 days (± 2 days). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Shampoo

Serious: 0/10 (0%)

Deaths: 0/10

Test Bath Foam

Serious: 0/10 (0%)

Deaths: 0/10

Test Head to Toe Wash

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (11 terms — click to expand)

Reaction	System	Test Shampoo	Test Bath Foam	Test Head to Toe Wash
Rash papular	Skin and subcutaneous tissue disorders	—	—	—
Tonsillitis	Infections and infestations	—	—	—
Viral rash	Infections and infestations	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Bronchiolitis	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Miliaria	Skin and subcutaneous tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT02403999 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skin care interventions in infants for preventing eczema and food allergy.
   Kelleher MM, Cro S, Cornelius V, Lodrup Carlsen KC, et al · · 2021 · cited 43× · PMID 33545739 · DOI 10.1002/14651858.cd013534.pub2
2. Skin care interventions in infants for preventing eczema and food allergy.
   Kelleher MM, Phillips R, Brown SJ, Cro S, et al · · 2022 · cited 29× · PMID 36373988 · DOI 10.1002/14651858.cd013534.pub3