NCT02985736已完成4 期
An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月最近更新:
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
- 20
- 试验地点
- 1
- 主要终点
- Investigator Global Assessment (Scalp Only)
研究概览
简要总结
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis
详细描述
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)
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 scalp psoriasis.
- •IGA of mild or greater (scalp only) determined at screening
- •Scalp surface area of 30% or greater determined at screening
- •Able to give written informed consent prior to performance of any study related procedures.
- •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
- •<30% scalp surface area
- •Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
- •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).
- •Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- •Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
- •Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
- •Patient received psoralen and Ultraviolet A, 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
Experimental
干预措施: Topicort Topical Spray (Drug)
结局指标
主要结局
Investigator Global Assessment (Scalp Only)
时间窗: 16 weeks
Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Topical Psoriasis Study for Patients Receiving Biologic TherapyPsoriasisNCT02983981Psoriasis Treatment Center of Central New Jersey20
已完成
3 期
Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic DermatitisAtopic DermatitisNCT05142774Organon and Co728
已完成
1 期
Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal CandidiasisCandidiasis, OralNCT06120816Sanotize Research and Development corp.6
已完成
3 期
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)Plaque PsoriasisNCT04053387Organon and Co763
进行中（未招募）
4 期
A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic DermatitisDermatitis AtopicNCT05983068Sanofi48