NCT03080545已完成4 期
An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy
研究概览
简要总结
Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.
详细描述
A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ≥ 18 years of age.
- •Diagnosis of chronic plaque-type psoriasis.
- •Able to give written informed consent prior to performance of any study related procedures.
- •Treated with a biologic agent for a minimum of 24 weeks at baseline.
- •Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
- •Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- •Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
排除标准
- •>5% Body Surface Area
- •Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
- •Pregnant or breast feeding, or considering becoming pregnant during the study.
- •Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- •Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
- •Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
- •Patient received UVB phototherapy within 2 weeks of Baseline.
- •Patient received PUVA phototherapy within 4 weeks of Baseline.
- •Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
研究组 & 干预措施
Open Label Enstilar
Experimental
open label
干预措施: Enstilar 0.005%-0.064% Topical Foam (Drug)
结局指标
主要结局
Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy
时间窗: 16 weeks
pga x bsa
次要结局
- dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire(16 weeks)
- Physician Global Assessment(16 weeks)
- Body Surface area(16 weeks)
研究者
研究点 (1)
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