A Tolerability Assessment Study of Three Wash Products in Infants

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Skin Care

Treatments: Other: Test bath foam; Other: Test shampoo; Other: Test head to toe wash

Study type: Interventional

Funder types: Industry

Identifiers

NCT02403999

RH02709 (Other Identifier)

203080

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 1 day to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Test shampoo

Experimental group

Description:

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

Treatment:

Other: Test shampoo

Test bath foam

Experimental group

Description:

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

Treatment:

Other: Test bath foam

Test head to toe Wash

Experimental group

Description:

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

Treatment:

Other: Test head to toe wash