EUCTR2017-004451-24-ES进行中（未招募）1 期
Phase IV, unicentric, open-label, randomized clinical trial to evaluate clinic and non-invasive response to clobetasol cream versus betamethasone dipropionate and calcipotriol foam treatments in plaque psoriasis.
Fundació Clínic per a la Reserca Biomèdica0 个研究点目标入组 36 人开始时间: 2017年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
- •Patients who agree to participate in the study and sign the informed consent (IC).
- •Patients diagnosed clinically and / or histologically from plaque psoriasis.
- •Men or women = 18 years.
- •Patients willing to comply with the requirements of the protocol and with the capacity to do so.
- •Outpatient patients
- •Patients who are candidates for treatment with any of the study medications.
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to any of the active principles or any of the excipients that appear listed in the technical data sheet of the study drugs.
- •Erythrodermic, exfoliative or pustular psoriasis.
- •Patients with known disorders in calcium metabolism.
- •Acute renal failure.
- •Acute liver disorders.
- •Facial or genital psoriasis.
- •Patients with viral skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, atrophic streaks, fragility of skin veins, ichthyosis, acne vulgaris, acne Rosacea, rosacea, ulcers and wounds.
- •Systemic treatment including cyclosporin A, methotrexate and steroids in the last 4 weeks.
- •Patients who have received systemic treatment with biological therapies, commercialized or not, with possible effect on plaque psoriasis during the following periods:
- •- etanercept: 4 weeks before visit 1 (week 0)
- •- adalimumab, alefacept, infliximab: 2 months before visit 1 (week 0)
- •- ustekinumab; 4 months prior to visit 1 (week 0)
- •- experimental products: 4 weeks or 5 half-lives (whichever is longer) prior to visit 1 (week 0)
- •Patients who have received topical treatment in the last 15 days.
- •Patients who have received treatment with phototherapy during the following periods:
- •- PUVA: 4 weeks before visit 1 (week 0)
- •- UV-B: 2 weeks before visit 1 (week 0)
- •History of concomitant serious systemic inflammatory cutaneous diseases.
- •Pregnant or lactating women
- •Patients who have participated in another clinical study in the 30 days prior to randomization.
研究者
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