Vulval lichen sclerosis Skin and Connective Tissue Diseases
Conditions
Interventions
In the intervention group participants will be asked to apply potent or superpotent topical corticosteroid (TCS) on two non-consecutive days per week even in the absence of symptoms (proactive treatme
Sponsors
Nottingham Clinical Trials Unit
Eligibility
Sex/Gender
Female
Age
5 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Clinical or biopsy confirmed diagnosis of vulval LS 2. Currently controlled disease (asymptomatic with minimal clinical evidence of active disease) at baseline 3. Age =5 years 4. Able to give consent/child assent plus parental consent
Exclusion criteria
Exclusion criteria: 1. Previous vulval intraepithelial neoplasia (VIN) or vulval squamous cell carcinoma (SCC) 2. Contraindications to topical steroids 3. Concomitant use of other topical anti-inflammatory vulval treatments 4. Using systemic immunosuppressants (for any indication) 5. Using systemic treatment for LS 6. Patients with surgical alteration of vulval skin as part of gender reaffirming surgery, or patients not born with a vulva 7. Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of flares over 12 months. Flare is defined as the worsening of symptoms requiring increased application of TCS, measured via text/app/email reminders every 2 weeks for 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effectiveness: 1. Progression of scarring, assessed by a blinded assessor at 12 and 24 months by comparing the post-randomisation assessment to baseline photographs (if patients consented), or assessed clinically if consent has not been given for photographs: 1.1. Adults: scarring worsened (yes/no). 1.2. Children and adolescents: failure of normal vulval development (clinical assessment) and/or evidence of scarring (yes/no) 2. Vulval Architectural Severity Scale (VASS) at 12 and 24 months post-randomisation, assessed clinically 3. Time to first flare, measured via text/app/email reminders at the point of first flare 4. Clinician global severity assessment of LS using a 5-point ordinal scale at 3, 6, 12, 18 and 24 months. Also assessed by a blinded assessor at 12 and 24 months. This will be measured via clinical assessment. 5. Condition-specific quality of life (QoL) measured at 3, 6, 12, 18 and 24 months using: 5.1. Vulvar Quality Life Index (VQLI) (adults) 5.2. Children’s Dermatology Life Quality Index (CDLQI) (adolescents and children) 5.3. Sexual function (adults only) assessed using the Female Sexual Function Index at 12 and 24 months Safety: 1. Adverse reactions (e.g. stinging, skin thinning) measured throughout the trial by patient-reported symptoms and clinical examination from randomisation over 24 months 2. Development of vulval intraepithelial neoplasia or vulval squamous cell carcinoma at 24 months, measured by clinical assessment and/or medical notes Treatment acceptability and potential barriers/facilitators to treatment: 1. Acceptability of treatment strategy measured using a Likert scale at 12 and 24 months 2. Adherence to treatment measured using a bespoke questionnaire completed by participants at 3, 6, 12, 18 and 24 months 3. Qualitative interview sub-study at 12 months Cost-effectiveness: 1. Generic utility instrument to measure QoL at 3, 6, 12, 18 and 24 months with EQ-5D-5L (adolescents and adults) and Child Health Utility Instrumen | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactPEARLS Study Team
Outcome results
None listed