A Tolerability Assessment Study of Three Wash Products in Infants

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

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.

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