NOVel moisturiser for Atopic dermatitis - skin barrier, version 1.0
Research type
Research Study
Full title
A phase 2 randomised controlled trial of a NOVel moisturiser for Atopic dermatitis: effect on the skin barrier in adults with a predisposition to a skin barrier defect
IRAS ID
251853
Contact name
Michael Cork
Contact email
Sponsor organisation
Perrigo/ACO Hud Nordic AB
Eudract number
2018-002945-12
Duration of Study in the UK
0 years, 3 months, days
Research summary
Research Summary
Will a novel moisturizer for atopic dermatitis have effect on the skin barrier in adults with a predisposition to a skin barrier defect?
Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease. AD is a multifactorial disease that is influenced by inheritance as well as the environment and the patients have a genetically impaired skin barrier. The skin barrier integrity can be evaluated by measuring the trans epidermal water loss (TEWL).
The use of moisturizers in AD is almost instinctive and is emphasized by healthcare personnel, also when the eczema is cleared. Moisturizer therapy has been shown to improve the skin barrier and a reduced risk of AD relapse may be expected by strengthening of an impaired barrier function. However, differences among moisturizers have been noted and documentation of their clinical effect is therefore imperative.This trial will include 40 adults with a history of AD that will be recruited from the general population by open advertisement. Enrolled participants will be randomized to treat the lower or upper parts of the lower volar forearms (i.e. 4 treatment areas) with the novel moisturizer, a reference cream containing 20% glycerol or a reference cream without humectant. One area is left untreated as control. The creams will be applied twice daily for 28 days. On day 1 and 29 the TEWL and skin moisture is measured on their forearms to evaluate the effect on skin barrier function and skin hydration. On day 31, after challenge with an irritant on day 29, the susceptibility to irritation will be evaluated by measuring TEWL on their forearms. Participants will attend visits at the start of randomized therapy and on day 5, 15, 29 and 31. The participants will also evaluate the tolerability of the different creams.
Summary of Results
Eczema (atopic dermatitis; AD) is a very common itchy skin condition affecting 1 in 5 children and up to 1 in 10 adults worldwide. The skin of eczema sufferers is prone to redness, irritation and dryness because it does not form an effective barrier. The regular use of emollients is recommended for all patients with eczema. Despite this widespread use, relatively little is known about how commonly prescribed emollient creams affect the skin's barrier.
This study compares the skin barrier‐strengthening properties of a new moisturizer, containing urea and glycerol, to a moisturizer containing glycerol but no urea, a simple paraffin cream, and no treatment. In contrast to the simple paraffin cream, the urea/glycerol cream strengthened the skin barrier, increasing natural moisturizing factor levels in the skin, and imparting protection from irritation. By improving the function of the skin barrier, the urea/glycerol cream has the potential to improve the long‐term control of eczema.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0311
Date of REC Opinion
4 Dec 2018
REC opinion
Further Information Favourable Opinion