Proactive against reactive treatment for lichen sclerosus

Phase 4

• Conditions: Vulval lichen sclerosis; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN72275160
• Lead Sponsor: ottingham Clinical Trials Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-08
• Last Update Posted: 12 August 2024
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber 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.