Effect of simvastatin in combination with a superpotent topical corticosteroid in bullous pemphigoidA prospective multi-centre randomised double-blind placebo-controlled pilot study

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 1

Inclusion Criteria

•Patients with newly diagnosed or relapsing bullous or pruriginous pemphigoid:
The diagnosis is based on clinical symptoms typical for active bullous or pruriginous pemphigoid: blisters, urticarial plaques, pruriginous papules or eczematous skin alterations.
The clinical extent of BP at screening must exceed values for Bullous Pemphigoid Disease Area Index (BPDAI) of = 15 (15 or more of max. 240 without damage) or modified Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) of = 5 (5 or more of max. 150).
Newly diagnosed patients only:
positive direct immunofluorescence (DIF) with linear deposition of IgG and/or C3 at the dermo-epidermal basal membrane zone
All patients:
1. optional: skin biopsy (histological evidence for subepidermal blister formation)
2. IgG reactivity with blister roof of saline-split human skin using indirect immunofluorescence and IgG reactivity against BP180 and/or BP230 by ELISA
•Male and female patients aged =55 years
•Only confirmed postmenopausal female patients, whose last menorrhoea occurred more than 1 year ago.
• Written informed consent by patient or written informed consent of the patient’s legal representative
•Karnofsky-Index = 30%

Exclusion Criteria

•Predominant or exclusive mucosal involvement
•Treatment with systemic corticosteroids >10mg prednisolone equivalent if systemic corticosteroids cannot be completely tapered until study visit 1
•Treatment with systemic corticosteroids = 10mg prednisolone equivalent for a time period less than four weeks prior to randomisation
•Hypersensitivity to Simvastatin or other ingredients of the IMPs
•Treatment with topical calcineurin inhibitors, dapsone, immunosuppressive drugs (azathioprine, mycofenolate mofetil, cyclophosphamide, methotrexate, ciclosporin) or tetracyclines within the past month prior to randomisation
•Treatment with intravenous immunoglobulins, immunoadsorption or TNF-alpha antagonists within the past 3 months prior to randomisation
•Treatment with rituximab or leflunomide within the past 12 months prior to randomisation
•Concurrent treatment with potent CYP3A4-inhibitors (itraconazole, ketoconazole, fluconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin, nefazodon)
•Concurrent treatment with less potent CYP3A4-inhibitors (verapamil, diltiazem, voriconazol, danazol, fibrates, niacin, amiodarone, gemfibrozil, fusidic acid, consumption of grapefruit juice)
•Treatment with simvastatin or other statins four weeks prior to randomisation
•Chronic muscle diseases or increase of creatine kinase above 2.5fold of normal value
•Hereditary muscle diseases in medical history
•Contact hypersensitivity to clobetasol
•Renal dysfunction (creatinine clearance<30ml/min according to the Cockcroft and Gault Formula (30))
•Untreated hypothyreosis
•Active liver disease or prolonged increased transaminase levels >3x upper limit of normal and increased total bilirubin>3mg/dl
•Alcohol dependency
•poorly controlled diabetes mellitus (glycohaemoglobin > 8,0 %)
•Inability to apply topical glucocorticoids and to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
•Illiteracy or insufficient language skills (German) to complete the questionnaires
•Simultaneous participation in another clinical trial except if that other trial does not affect the study as approved and documented by the principal investigators

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Yearly accrual rate<br>•Proportion of patients compliant with interventional treatment<br>•Proportion of patients adhering to planned study visits<br>

Secondary Outcome Measures

Name	Time	Method

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