EUCTR2020-004081-19-DE进行中（未招募）1 期
Double-blind, randomised clinical study comparing efficacy and safety of Betamethasone dipropionate 0.64 mg/g _ Salicylic acid 30 mg/g Ointment (Test) vs. Diprosalic(R) Ointment (Reference) vs. Vehicle in patients with chronic stable plaque psoriasis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 306
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Women and men = 18 years of age
- •- Written consent to study participation after patient information by the investigator
- •- Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk
- •- Psoriasis affecting = 10% of the total body surface area (BSA)
- •- A modified PASI score of = 5 to = 15 at baseline
- •- For women of childbearing potential: Application of an efficient contraceptive method during the whole study
- •- For women of childbearing potential: Pregnancy test with negative result prior to study start
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis
- •Systemic therapy of psoriasis within the last 4 weeks before study inclusion and during the study
- •Use of topical anti-psoriatic therapy (including topical retinoids, topical corticosteroids, vitamin D analogues, salicylic acid, dithranol, coal tar) within two weeks prior study inclusion
- •Known intolerance or hypersensitivity against salicylic acid, betamethasone dipropionate or other glucocorticoids or any of the other ingredients in the study medication
- •History of psoriasis unresponsive to topical treatment
- •Current or past history of renal insufficiency or severe hepatic disorders
- •Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds and vaccination reactions
- •Other inflammatory skin disease in the treatment area that may confound the evaluation of the stable plaque psoriasis (e.g. atopic dermatitis, contact dermatitis, tinea corporis)
- •Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment area, which could interfere with the rating of efficacy and safety parameters
- •Other severe acute or chronic concomitant disease with severe impairment of the general condition
- •Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
- •Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
- •Reasonable doubt concerning the co-operation of the patient
- •Participation in another clinical study within the last 30 days prior to inclusion in this study
- •Participation in this study at an earlier date
- •Women with existing or intended pregnancy or during lactation
研究者
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