An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Psoriasis Severity
研究概览
简要总结
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks
详细描述
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks.
Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients will receive Topicort® BID for 4 weeks.
After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 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.
- •Malignancy or history of malignancy, except for:
- •treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- •treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
- •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 Topicort Spray® as stated in the label.
研究组 & 干预措施
open label
Topicort topical spray
干预措施: Topicort Topical Spray (Drug)
结局指标
主要结局
Psoriasis Severity
时间窗: 16 weeks
Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.
次要结局
- Dermatology Life Quality Index(16 weeks)
- Psoriasis Severity(16 weeks)