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Systemic therapy for vulval Erosive Lichen Planus (the 'hELP' trial): study protocol for a randomised controlled
Rosalind C Simpson1, Ruth Murphy2, Daniel J Bratton3
1Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, Lenton Lane, NG7 2NR, Nottingham, UK. Rosalind.simpson@nottingham.ac.uk.
Trials
|January 6, 2016
Summary
This study investigates systemic therapies as a second-line treatment for erosive lichen planus affecting the vulva (ELPV). It aims to provide evidence for effective treatments beyond topical corticosteroids for this rare condition.
Area of Science:
- Dermatology
- Clinical Trials
- Vulvar Diseases
Background:
- Erosive lichen planus affecting the vulva (ELPV) is a rare, chronic condition causing significant pain and impacting daily life.
- Current treatment guidelines lack robust evidence for second-line therapies beyond topical corticosteroids.
- The 'hELP' study is a randomized controlled trial (RCT) designed to address this evidence gap.
Purpose of the Study:
- To evaluate the efficacy of systemic therapies as an add-on to standard topical treatment for ELPV.
- To compare adjunctive systemic treatments (hydroxychloroquine, methotrexate, mycophenolate mofetil, prednisolone) against topical therapy with a short course of oral prednisolone.
Main Methods:
- A four-armed, open-label, pragmatic randomized controlled trial (RCT) with a blinded independent clinical assessor.
- Recruitment of 96 participants for full trial, with an initial pilot phase of 40 participants.
- Primary outcome: treatment success at 6 months, defined by a composite measure of patient and clinician assessment.
Main Results:
- The study is the first RCT to investigate second-line treatments for ELPV.
- It highlights unique methodological challenges and the need for collaborative efforts in conducting trials for rare diseases.
- Results regarding treatment efficacy are pending completion of the trial.
Conclusions:
- The 'hELP' study represents a significant effort to provide high-quality evidence for ELPV management.
- Successful completion of this RCT will inform clinical practice and guide future treatment strategies.
- Collaboration between clinical networks and expert clinicians is crucial for rare disease research.
