Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial

Background 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. Trial registration ClinicalTrials.govNCT0365666. Registered on 4 September 2018.

Complements C3 and C4 in serum and stimulatedsaliva of patients suffer oral erosive lichen planus

Introduction: The objective of this study was to compare the level of complements C3 and C4 in serum, and stimulated saliva between oral lichen planus (OLP) and healthy individuals. Methods: A case-control study was performed on 31 healthy and 31 who suffer the erosive type of OLP. Serum and saliva level of C3 and C4 were measured by immunoturbidimetry method. Results: C3 and C4 were expressed at a lower level in serum and saliva of OLP patients compared to control groups. Serum C3 and C4 levels did not correlate with their saliva levels. The receiver operating characteristic analysis showed significantly diagnostic abilities for serum and saliva C3 and C4 to discrimination of OLP patients from controls (cutoff [mg/dl] for C3 were 83 in serum and 3.45 in saliva and for C4 were 9.5 in serum and 0.9 in saliva). Conclusion: Serum and salivary levels of total C3 and C4 were lower in patients with OLP than in healthy controls. Therefore, they may able to discriminate OLP from healthy.

Correlation Of Clinical Severity Of Oral Lichen Planus With Treatment Prognosis - A Retrospective Institution Based Study

Lichen planus is a chronic mucocutaneous immunologically mediated disease which is triggered by varied etiological agents. Lichen planus shows many clinical features affecting the skin, oral cavity, genital organ, nail and scalp. Lichen planus has well documented clinical findings and histological findings that aid in diagnosis. This retrospective study was done to assess the clinical severity of Oral Lichen Planus (OLP) and compare it to the treatment prognosis of the patients visiting our institution. A total of 60 clinically diagnosed OLP patients were included. Clinical and treatment details were recorded and tabulated using Excel. The collected data were then analyzed by appropriate statistics using SPSS software. The results revealed 60% of the cases to be females with 58.3% accounting for the erosive type of lichen planus. 60% had involvement of bilateral buccal mucosa. Erosive variant showed eight months duration of treatment using systemic steroids. Within the limitations of the study, we observed that OLP accounts for nearly 28.4% of the OPMD reporting to the institution and females were found to be more commonly affected than males. Erosive lichen planus was the most common variant which exhibited maximum treatment duration. Hence, it is necessary to follow up the OLP patients regularly and to provide a precise treatment which prevents the remission of the disease in these patients.