E45 in-use tolerance study in babies and children with dry/atopic skin
Research type
Research Study
Full title
An open label, in-use tolerance study in babies and children with dry/atopic and very dry/atopic skin, to evaluate the acceptability and skin tolerability of E45 Eczema Repair Emollient for the treatment of atopic or eczema prone skin
IRAS ID
212759
Contact name
K Rashid Haye
Contact email
Sponsor organisation
Reckitt Benckiser
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 4 days
Research summary
Atopic dermatitis/ eczema is a long term inflammatory itchy skin condition that reportedly affects up to 20% of children in the UK alone. The skin provides a barrier to the loss of water and the penetration of irritants and allergens from the environment. In atopic dermatitis/ eczema the outer layer of skin is damaged. The National Institute for Health and Care Excellence (NICE) recommends the use of emollients for treating atopic eczema focusing on repairing the skin barrier.
E45 Eczema Repair Emollient has been designed by Reckitt Benckiser as a ‘leave on’ treatment for the dry stages of eczema in adults and children over 3 months and is based on a currently marketed product but with a new preservative system.
This new formulation is a Class I non-invasive Medical Device as it provides symptomatic relief from atopic eczema by creating a physical barrier on the skin. It has been tested previously on generally healthy adults with dry/ very dry skin and was found to be non-irritant.
This study is therefore to test how well the skin of approximately 35 subjects between ≥3 months and <12 years with dry/ very dry eczema prone skin, tolerates the use of the product after 2 to 3 times daily application to the test site (left/right whole arm/leg) over a 2 week period. This will be assessed by visual assessments of irritation at each visit and a global assessment at the end of the study by a dermatologist and parental assessments of how well the skin has tolerated the use after 1 week and 2 weeks of use.
This study will be conducted in the UK at Intertek CRS over approximately 1 month, where subjects attend the study site on 4 occasions which are an initial screening visit, Day 0, Day 7 and Day 14.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0261
Date of REC Opinion
28 Sep 2016
REC opinion
Further Information Favourable Opinion