MOSAIC:Salivary cortisol in genital skin treated with topical steroids
Research type
Research Study
Full title
The MOSAIC study: Monitoring Of Salivary cortisol in Anogenital skin Inflammation treated with topical Corticosteroids
IRAS ID
325526
Contact name
Harriet Corbett
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Steroids are important medications, but they are associated with side effects, the most serious is suppression of the adrenal glands. Adrenal suppression can be life threatening so people taking steroid medicines are given a 'Steroid Treatment Card' to help everyone know that they are at risk. Very high doses of steroid cream may cause adrenal suppression although the amount of cream that causes this problem is not well known. Recently we have been advised to give steroid treatment cards to all children given steroid cream to treat abnormal genital skin, even though the amount of cream used is quite small. This is because genital skin is thin and may absorb more steroid medicine compared to other parts of the body. There are no research studies looking at how much cream would cause a problem though blood tests in a small number of girls treated for Lichen sclerosus (who need to use more cream) do suggest a problem.
Steroid treatment cards may cause worry, some patients may not use the cream as advised because of that. This study will measure the level of children's own steroid hormones before, during and after a course of treatment with steroid cream to their genitalia. The tests will be done in a non-invasive way (no blood tests!) by measuring cortisol and cortisone in saliva. The aim is to see if the amount of cream used to treat [1]a common problem in boys (non-retractile foreskin) and [2]an uncommon but related condition in girls (lichen sclerosus) causes adrenal suppression. The study will recruit 50 boys and 5 girls over 1 year, if there is no sign of a problem then the study will end but if there is any suspicion of adrenal suppression then a substantive study will be designed.
REC name
London - Stanmore Research Ethics Committee
REC reference
23/PR/0764
Date of REC Opinion
26 Jul 2023
REC opinion
Further Information Favourable Opinion