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A Tolerability Assessment Study of Three Wash Products in Infants

NCT ID: NCT02403999

Last Updated: 2018-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2015-04-27

Brief Summary

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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

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Conditions

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Skin Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Test shampoo

Intervention Type 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

Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.

Group Type EXPERIMENTAL

Test bath foam

Intervention Type 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

Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.

Group Type EXPERIMENTAL

Test head to toe wash

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TKL Research, Inc.

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RH02709

Identifier Type: OTHER

Identifier Source: secondary_id

203080

Identifier Type: -

Identifier Source: org_study_id