DRKS00003851进行中（未招募）2 期
Effect of simvastatin in combination with a superpotent topical corticosteroid in bullous pemphigoidA prospective multi-centre randomised double-blind placebo-controlled pilot study - SICOPEM
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 one（—）
- 性别
- All
入选标准
- •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%
排除标准
- •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
研究者
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