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dc.contributor.authorSkullerud, Kristin Helene
dc.contributor.authorGjersvik, Petter
dc.contributor.authorPripp, Are Hugo
dc.contributor.authorQvigstad, Erik
dc.contributor.authorHelgesen, Anne Lise Ording
dc.coverage.spatialNorway, Osloen_US
dc.identifier.citationTrials. 2021, 22 (1), 1-10.en_US
dc.description.abstractBackground: Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial. Methods: We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a specialised vulva clinic in Oslo, Norway. The patients will be randomised 1:1 to either apremilast 30 mg BID (with an initial dose titration on days 1–6) or a placebo for 24 weeks. The concomitant use of topical corticosteroids will be allowed. The primary end point will be the mean GELP score, a clinical scoring system, at week 24 in the apremilast-treated patients versus the placebo-treated patients. The secondary end points will include the mean GELP score improvement from weeks 0 to 24, patient-reported use of topical steroids, the pain score on a visual analogue scale and the number of patients with GELP score improvements at weeks 16 and 24. The Physician Global Assessment , Patient Global Assessment and selected quality of life and sexual function assessments will be recorded at weeks 0, 16 and 24. The exploratory endpoints include description of immunohistochemical changes before and after apremilast therapy, assessed in vulvar or vaginal biopsies at weeks 0 and 24. Regular follow-ups for possible adverse events will be conducted. Discussion: The study design is based on experience from studies on apremilast in other inflammatory skin diseases using equivalent apremilast doses for approved indications. The trial may provide evidence for the use of apremilast in women with this burdensome genital dermatosis.en_US
dc.description.sponsorshipThe Oslo University Hospital will pay the salaries of the investigators and personnel involved in the data collection, registration and analysis and will provide basic equipment for study visits. Celgene and, from 1 May 2020, Amgen will provide the study medication and cover expenses for data collection and monitoring, clinical visits, phone interviews, pharmacy services and immunohistochemical analyses.en_US
dc.relation.ispartofseriesTrials;22, Article number: 469 (2021)
dc.rightsNavngivelse 4.0 Internasjonal*
dc.subjectGenital erosive lichen planusesen_US
dc.subjectVulval diseasesen_US
dc.subjectPhosphodiesterase-4 inhibitorsen_US
dc.subjectRandomised clinical trialsen_US
dc.titleApremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trialen_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.rights.holder© The Author(s). 2021en_US

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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal