The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Histamine response after ethyl-α-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate
研究概览
简要总结
Participants with multiple sclerosis that are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site will be recruited to examine histamine response of three topical treatments to reduce these symptoms.
详细描述
Participants are asked to be in this study because they have multiple sclerosis, are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site.
The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by redness, swelling, and itch response following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple Sclerosis (MS).
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent
- •Between ages 19-65
- •Laboratory supported diagnosis of multiple sclerosis
- •Currently treated with injectable GA, experiencing wheal and flare after injection
排除标准
- •Unable to give informed consent
- •Treated with any other therapy for Multiple Sclerosis
研究组 & 干预措施
placebo
inactive cream
干预措施: topical placebo cream with no active ingredients (Drug)
Steroid Cream
1% steroid cream
干预措施: 1% Steroid Cream (Drug)
AGEE cream
AGEE cream is a creatine ethyl ester based product (an amino acid) that can be purchased over-the-counter without a prescription and is not FDA controlled
干预措施: AGEE cream (Drug)
结局指标
主要结局
Histamine response after ethyl-α-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate
时间窗: Three weeks
To determine if the use of ethyl-α-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by wheal, flare and itch response following subcutaneous injection of glatiramer acetate for the treatment of Multiple Sclerosis
次要结局
未报告次要终点