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Completed

NCT Number: NCT02403999

A Tolerability Assessment Study of Three Wash Products in Infants

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.

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Key information

Conditions

Skin Care

Age range

1 day–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Edinburgh, EH1 3RH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test shampoo

Other

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 foam

Other

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 wash

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • TKL Research, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2015
Registry last updated
Dec 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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