SMART2 Skin bioMARkers for atopic eczema Therapy evaluation study 2
Research type
Research Study
Full title
Validation of a novel composite of skin biomarkers as a primary outcome measure for evaluating the safety of treatments for atopic dermatitis study 2: a randomised controlled trial (phase 2) comparing the effects of crisaborole 2% ointment to betamethasone valerate 0.025% cream on skin structure and function in participants with atopic dermatitis.
IRAS ID
1005095
Contact name
Simon Danby
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2022-000560-21
ISRCTN Number
ISRCTN52806782
Research summary
The first-choice drug treatment for mild-moderate eczema is currently a topical corticosteroid. By topical, we mean the treatment is intended for application directly to the skin. Whilst topical corticosteroids are effective at treating eczema, they have been found to cause unwanted skin changes, such as skin thinning, if used inappropriately over long periods of time. Exactly how much unwarranted thinning is caused by different treatment routines is unclear, so we want to use some new non-invasive ways to measure skin thinning to better understand the problem. One of these ways is to take a 3D image of the skin using a technique called OCT, which is similar to ultrasound. Because the methods are so sensitive, the signs of skin thinning can be seen before the skin becomes visibly damaged.
Crisaborole ointment is a new non-steroidal drug treatment for eczema that appears to be as effective as some topical corticosteroids, and is not expected to cause abnormal skin thinning. Betamethasone valerate cream is one of the most commonly prescribed topical corticosteroids for eczema in the UK, and is available in a number of preparations with different potencies or strengths. Therefore, the aim of the SMART program of studies is to conduct trials in eczema patients involving treatment of separate areas of their skin with either crisaborole ointment or betamethasone valerate cream of different potencies. The effects of the treatments will be assessed using the non-invasive skin imaging techniques.
Both types of treatment have already been tested in clinical trials for clinical efficacy, and so efficacy will not be assessed again here. This study will confirm whether or not crisaborole ointment causes the same unwarranted skin thinning caused by the moderately potent betamethasone valerate 0.025% cream in a direct comparison.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0172
Date of REC Opinion
13 Oct 2022
REC opinion
Further Information Favourable Opinion