EUCTR2013-002861-20-PL进行中（未招募）不适用
A multi-centre, randomised, double-blind, parallel-group phase III study to investigate the efficacy, safety, and tolerability of a generic calcipotriol-betamethasone ointment formulation compared to Daivobet® and vehicle in the treatment of adult patients with chronic stable plaque psoriasis - Trial on Efficacy, Safety and Tolerability of Calcipotriol-Betamethasone Sandoz
ek Pharmaceuticals d.d.0 个研究点目标入组 411 人开始时间: 2013年12月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 411
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1] Male or female patients =18 years of age.
- •[2] Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk (but excluding face, scalp, genitals and intertriginous areas).
- •[3] Psoriasis affecting less than 30% of the body surface area (BSA).
- •[4] A modified PASI score of =5 to =15 at baseline (Visit 2).
- •[5] Female patients of childbearing potential must have a negative pregnancy test prior to randomisation and must agree to use an appropriate method of contraception during the study.
- •[6] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled visits, and compliance with protocol requirements as evidenced by providing signed written informed consent.
- •[7] An albumin-corrected serum calcium level below the upper reference range limit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 411
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 411
排除标准
- •- History of hypersensitivity or intolerance to any active substance or any of the excipients of the study medication
- •- History of hypersensitivity to Adrenocorticotropic hormone (ACTH), Synacthen® or Synacthen® Depot
- •- Current diagnosis of unstable forms of psoriasis in the area(s) to be treated with study medication, including guttate, erythrodermic, exfoliative, or pustular psoriasis
- •- Other inflammatory skin disease in the area(s) to be treated with study medication that may confound the evaluation of plaque psoriasis
- •- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the area(s) to be treated with study medication which could interfere with efficacy evaluation
- •- History of psoriasis unresponsive to topical treatments
- •- Viral lesions of the skin
- •- Fungal or bacterial skin infections
- •- Parasitic infections
- •- Skin manifestations in relation to tuberculosis or syphilis
- •- Perioral dermatitis
- •- Atrophic skin, striae atrophicae
- •- Fragility of skin veins
- •- Ichthyosis
- •- Acne vulgaris, acne rosacea, rosacea
- •- Dermal ulcers, wounds
- •- Perianal and genital pruritus
- •- Allergic disorders or susceptibility for allergic reactions
- •- Active infectious diseases
- •- Peptic ulcer
- •- Refractory heart failure
- •- Any of the following conditions, whether known or suspected: endocrine disorders, Cushing’s syndrome, primary adrenocortical insufficiency, diabetes mellitus
- •- Current or past history or signs/symptoms suggestive of a clinically significant abnormality in calcium homeostasis with hypercalcaemia, vitamin D toxicity, severe renal impairment (CRCL <30 ml/min), or severe hepatic disorder (total bilirubin, AST, ALT, GGT, or AP >3 times the upper limit of normal)
- •- Use of topical anti-psoriatic therapy within 2 weeks prior to baseline (Visit 2) and during the study
- •- Use of systemic corticosteroids within 3 months prior to baseline (Visit 2) and during the study
- •- Use of other systemic anti-psoriatic therapy, systemic antibiotics, or systemic anti-inflammatory agents within 1 month prior to baseline (Visit 2) and during the study
- •- Use of immunosuppressive drugs or oral retinoids within 2 months prior to baseline (Visit 2) and during the study
- •- Chemotherapy or radiation therapy within 3 months prior to baseline (Visit 2) and during the study
- •- Use of systemic anti-psoriatic biologic therapy within 6 months prior to baseline (Visit 2) and during the study
- •- Psoralen + UVA (PUVA) therapy or UVB therapy within 1 month prior to baseline (Visit 2) and during the study
- •- Use of calcium supplements during the study
- •- More than 400 IU/day of vitamin D or vitamin D analogues during the study
- •- Initiation of or changes in non-anti-psoriatic concomitant medication(s) that could affect psoriasis during the study
- •- Initiation of or changes to concomitant medication that could affect calcium metabolism during the study
- •- Change in sleep pattern within 1 month prior to baseline (Visit 2) and during the study
- •- Initiation of or changes in oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 1 month prior to baseline (Visit 2) and during the study
- •- Use of CYP P450 3A4 inducers within 1 month prior to baseline (Visit 2) and during the study
- •- Use of systemic CYP P450 3A4 inhibitors (e.g. ketoconazole, itraconazole, metronidazole) within 1 month prior to baseline (Visit 2) and during the study
- •- Use of topical CYP P450 3A4 inhibitors (e.g.
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