NCT01279629暂停不适用
Open Clinical Study, Comparing Non-inferiority for Efficacy of the Drug Tazarotene 0.1% Versus the Comparator Drug Calcipotriol 0.005% in the Treatment of Chronic Plaque Psoriasis
Glenmark Farmacêutica Ltda0 个研究点目标入组 50 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 50
研究概览
简要总结
The purpose of this study is:
To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis.
- Population:
50 patients will be selected from both sexes, healthy, between 18 and 65 years with a clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of inclusion and exclusion.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: Between 18 and 65
- •A patient with chronic plaque psoriasis
- •PASI <20%
- •Presence of bilateral lesions with at least 2 cm in diameter and each with some degree of symmetry
- •Levels of serum calcium and phosphorus within the normal range of reference or in case of changes, classified as irrelevant by the investigator
- •In the case of female patients, agreement or maintenance of safe use of contraception such as barrier (condom, diaphragm), hormonal contraceptives (pills, implants or injections), IUDs, or abstinence (no sex)
- •Reading, understanding, agreement and signature of the patient in the Term of Consent.
排除标准
- •Gestation (confirmed by urine test indicator)
- •Lactation
- •History of hypersensitivity to components of medicines
- •Psoriasis with different clinical presentation of the plates
- •Clinical picture of psoriasis involving only the scalp, face, groin, armpit and / or other intertriginous area
- •Patient requires the use of concomitant medication (topical or systemic) that may alter the course of the disease during the study period
- •Use of any systemic treatment for psoriasis within 12 weeks before the start of the study
- •Use of systemic corticosteroids within 28 days before the start of the study
- •Use of topical corticosteroids or other topical therapies in the areas of assessment within 02 weeks before the start of the study
- •Use of phototherapy (UVB / UVA-P) within 04 weeks before the start of the study
- •Patients who have participated in another clinical study within 30 days before the start of the study
- •Use of any medication or possession of any disease which, in the opinion of the investigator might interfere with the performance or interpretation of the study
- •Laboratory tests changed (serum AST and ALT, alkaline phosphatase, urea and creatinine, total bilirubin and fractions)
- •Patients with demonstrated hypercalcemia or evidence of toxicity of vitamin D
- •Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation
研究组 & 干预措施
Tazarotene 0.1%
干预措施: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%). (Drug)
Calcipotriol 0.005%
干预措施: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%). (Drug)
研究者
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