A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Efficacy and Safety of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Statistically significant changes in pain level
研究概览
简要总结
The purpose of this study is to find out how safe and effective an investigational drug called alefacept (amevive) is for the treatment of moderate to severe erosive mucosal lichen planus.
Lichen planus is a skin disease that can last a long time and cause significant pain, itching, and scarring. It can affect the mucous membranes (area inside the mouth and vagina) and these areas can become erosive (sores can develop). Currently there is no known cure for this disease.
An investigational drug is one that has not been approved by the United States (US) Food and Drug Administration (FDA) to treat a particular condition or disease. Alefacept has been approved to treat psoriasis (a scaly skin rash). A number of reports suggest that lichen planus develops for some of the same reasons as psoriasis, but alefacept is not yet approved for the treatment of psoriasis.
详细描述
Lichen planus is an inflammatory disorder that affects skin, mucous membranes (the skin in the mouth and vagina), nails, and hair. It is thought that T-cells (cells that help fight infection) become activated and multiply faster than normal and that this contributes to the development of the skin sores.
Alefacept works by slowing the rate at which T-cells become activated and helps to decrease the number of T-cells. By blocking the activity and decreasing the number of T-cells Alefacept may help improve the disease and decrease the sores on the skin.
Participants in this study will be randomly assigned to receive either alefacept or a placebo. A placebo looks just like the study drug but contains no active medication. Placebos help study doctors find out if the effects of the study drug are due to the drug itself or just because of being in the study. This type of study design helps measure the true effectiveness of a treatment. Participants have a 1 out of 2 chance of receiving alefacept and a 1 out of 2 chance of receiving placebo. Neither participants nor the study doctors will know which group participants have been assigned to.
The researchers expect to enroll 26 subjects in this study at research sites in the U.S. About 16 subjects will be enrolled at Brigham and Women's Hospital and Massachusetts General Hospital.
Biogen Idec., Inc. is the maker of alefacept and is the sponsor of this study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent, authorize release and use of protected health information
- •At least 18 years of age
- •Diagnosis of moderate to severe mucosal lichen planus
- •No systemic (oral or injectable) treatment of lichen planus for 4 weeks prior to starting study drug.
- •Willing to forgo changes in topical treatment (creams) for 4 weeks before receiving the study drug and during the course of the study.
- •Off of topical tacrolimus or pimecrolimus for 4 weeks prior to starting the study drug
- •CD4+ T lymphocyte counts must be above the lower limit of normal laboratory value
排除标准
- •Clinically significant abnormal laboratory values
- •Skin lesions currently undiagnosed, but suspicious for malignancy
- •Other skin disease that might interfere with lichen planus status assessments.
- •History of malignancy other than basal cell carcinomas or fewer than 3 squamous cell carcinomas
- •Exposure to systemic therapy for lichen planus within 4 weeks prior to enrollment.
- •Previous exposure to alefacept
研究组 & 干预措施
B
Placebo
干预措施: Placebo (Drug)
A
Amevive
干预措施: Amevive (Alefacept) (Drug)
结局指标
主要结局
Statistically significant changes in pain level
Statistically significant changes in appearance of lesions (sores)
次要结局
- Statistically significant changes in severity of itching
- Statistically significant changes in redness, amount of body surface area involved, number of sores, and or depth of involvement
- Statistically significant changes in quality of life