The MOSAIC study: monitoring cortisol levels in saliva of children using steroid creams on genital ski

Not Applicable

• Conditions: Urological and Genital Diseases; Treatment of lichen sclerosus or non-retractile foreskin in children.

• Registration Number: ISRCTN81893670
• Lead Sponsor: Alder Hey Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-23
• Last Update Posted: 6 November 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

BOYS: Males 5-15 years who are treatment naïve (no steroid medication of any kind in the previous 3 months) receiving potent topical steroid for pathological or physiological phimosis.

GIRLS: Pre-pubertal females aged 5-15 years who are treatment naïve (no steroid medication of any kind in the previous 3 months) receiving very potent topical steroid for LS following diagnosis made in the paediatric gynaecology/dermatology clinics.

Exclusion Criteria

1. Patients with oral conditions which could contaminate saliva samples with blood, such as current mouth ulcers or gingivitis.
2. Patients taking additional medications which are likely to impact on cortisol levels e.g. glucocorticoids, sex steroids, thyroxine, growth hormone, insulin, metformin, opiates, loperamide and azole compounds.
3. Children with a family history of adrenal insufficiency due to an inherited condition, including congenital adrenal hyperplasia.
4. Children <5 years of age and children at high risk of choking on the cotton wool roll used to collect the saliva.
5. The treating clinician does not consider it appropriate to delay treatment whilst the family consider the study and take the pre-treatment samples.
6. Recent (within 3 weeks) ingestion of liquorice

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. BOYS - change in EMSC and EMSCn from baseline to end of treatment (after 6 weeks) and one month following treatment measured by a laboratory test of salivary cortisol and cortisone<br> 2. GIRLS - change in EMSC and EMSCn from baseline to the end of the first 4 weeks of treatment and at the end of treatment (after 3 months) measured by a laboratory test of salivary cortisol and cortisone<br>