NCT02665221终止4 期
Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient Erythema Self-Assessment (PSA) Score 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline PSA Score of Injection Site Erythema at Least 2 Hours After PLEGRIDY Injection.
研究概览
简要总结
The primary purpose of this single center, randomized, open label study in relapsing Multiple Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect of Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of injection site erythema after PLEGRIDY injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A confirmed diagnosis of relapsing multiple sclerosis, as defined by McDonald criteria.
- •Age 18 to 70 years old, inclusive, at the time of informed consent.
- •Naïve to PLEGRIDY or less than or equal to 12 months on PLEGRIDY therapy.
排除标准
- •Primary progressive, secondary progressive or progressive relapsing MS.
- •Concurrent enrollment in any clinical trial of an investigational product.
- •Known allergy to any interferon or any component of PLEGRIDY (peginterferon beta-1a).
- •Known allergy to phenylephrine, pramoxane or any component of Preparation H.
- •History of hypersensitivity or intolerance to naproxen or acetaminophen (Tylenol) that would preclude the use of at least 1 of these during the study.
- •History of inadequate response to subcutaneous interferon beta therapy.
- •History of human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection.
- •History of premalignant and malignant disease including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- •History of seizure disorder or unexplained blackouts.
- •History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day
- •Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia), at the discretion of the Investigator, within 3 months prior to Day
- •History of drug or alcohol abuse (as defined by the Investigator) within 6 months prior to Day.
- •Active bacterial or viral infection.
- •Inability to comply with study requirements.
研究组 & 干预措施
Control group
Placebo Comparator
干预措施: No Treatment Arm (Other)
Treatment group
Experimental
干预措施: Topical Preparation H arm (Drug)
结局指标
主要结局
Patient Erythema Self-Assessment (PSA) Score 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline PSA Score of Injection Site Erythema at Least 2 Hours After PLEGRIDY Injection.
时间窗: 6 Hours
次要结局
- Width of Injection Site Erythema in Millimeters 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline Width of Injection Site Erythema at Least 2 Hours After Injection.(6 Hours)
- Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.(6 Hours)
研究者
研究点 (1)
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