Treatment of lichen sclerosus or non-retractile foreskin in children. Urological and Genital Diseases
Conditions
Interventions
Children who need to use steroid creams on genital skin will give saliva samples by chewing on a cotton wool roll and their salivary steroid levels will be measured. Girls and boys will take part but
Sponsors
Alder Hey Children's Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients with EMSC or EMSCn >2 standard deviations below the mean of a cohort of healthy child volunteers measured by a laboratory test of salivary cortisol and cortisone at the end of the study 2. Percentage change in EMSC/EMSCn measured by a laboratory test of salivary cortisol and cortisone at the end of the study 3. Amount of steroid used according to age and sex measured in grams of cream used from the prescribed tube at the time of returning samples 4. Acceptability of and compliance with the study protocol measured through number of samples returned and informal discussion with participants at the time of returning samples 5. Protocol completion measured by number of children completing study and number of samples actually taken compared to number expected at the end of the study 6. Adequacy of samples measured by a laboratory test of salivary cortisol and cortisone at the time of analysis 7. Number of children requiring referral to endocrinology for further evaluation measured using patient records at the end of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactHarriet Corbett
Outcome results
None listed