Erosive lichen planus affecting the vulva: defining the disease, developing outcome measures and designing a randomised controlled trial

Simpson, Rosalind C. (2015) Erosive lichen planus affecting the vulva: defining the disease, developing outcome measures and designing a randomised controlled trial. PhD thesis, University of Nottingham.

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Erosive lichen planus affecting the vulvovaginal region (ELPV) is a rare chronic inflammatory condition causing painful raw areas that can lead to scarring, at the vaginal entrance. Symptoms considerably impact upon daily function and quality of life. There is risk of cancerous change in affected skin of 1-3%.

A Cochrane Systematic Review, published in 2012, found no randomised controlled trials (RCT) on which to base treatment for ELPV. Retrospective case series suggest that super-potent topical corticosteroids are frequently used as first-line therapy, although one third of patients fail to respond adequately and require escalation of therapy. There is clinical uncertainty regarding which second-line therapies should be used.

The following steps were taken to inform the design of an RCT to determine optimal second-line therapy for EVLP resistant to topical steroids:

• A multi-centre retrospective review and audit of case notes to assess current clinical management in the UK.

• A qualitative investigation with UK clinicians to establish their views and principles of management of ELPV.

• An international multi-disciplinary electronic-delphi consensus exercise to agree a set of diagnostic criteria for ELPV.

• A systematic review to assess existing outcome measure tools that have been used in randomised controlled trials of vulval skin disorders.

• Assessment of patients views through a survey of a national patient group and subsequent focus groups with patients.

The resulting multi-centre, four-armed, open-label, pragmatic randomised controlled trial will compare hydroxychloroquine, methotrexate and mycophenolate mofetil against a standard care group of clobetasol propionate 0.05% plus a short course of oral prednisolone.

This will be the first RCT to test systemic agents for patients with ELPV and will add to the existing evidence base. The methodologies employed to develop the RCT protocol, and the trial design itself, may act as a template for clinical research into the therapeutic management of other rare inflammatory conditions.

Item Type: Thesis (University of Nottingham only) (PhD)
Supervisors: Thomas, K.S.
Murphy, R.
Keywords: Dermatology, Vulva, Genital, Erosive lichen planus, Randomised controlled trial, Outcome measures, Diagnostic criteria, Focus group, Qualitative, Quantitative
Subjects: W Medicine and related subjects (NLM Classification) > WR Dermatology
Faculties/Schools: UK Campuses > Faculty of Medicine and Health Sciences > School of Medicine
Item ID: 28301
Depositing User: Simpson, Rosalind
Date Deposited: 08 Oct 2015 10:41
Last Modified: 13 Sep 2016 23:09

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