NCT00301002已完成2 期
A Pilot Open-Label Study to Evaluate the Safety and Observe the Effectiveness of 16 Weeks of Alefacept in Palmar Plantar Pustulosis (IST 92)
The Guenther Dermatology Research Centre2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- percentage change in PPPASI from baseline
研究概览
简要总结
The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis.
详细描述
Palmar plantar pustulosis is a chronic, disabling skin condition which is difficult to treat since it is often recalcitrant to current treatments and associated with high recurrence rates. This condition appears to be a T lymphocyte mediated condition and is thought by some to be a subtype of psoriasis. Alefacept affects T cell activation and induces apoptosis of memory T cells. It has been shown to be efficacious in the treatment of psoriasis vulgaris and may be associated with prolonged remissions. There is extremely limited experience with use of Alefacept in Palmar Plantar Pustulosis. This pilot trial should provide additional information concerning its use for this indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subjects must have stable, moderate, severe or very severe palmar plantar pustulosis.
- •Must have a minimum of at least 3 pustules on 1 sole or palm.
- •Must give written informed consent.
- •Subjects must be 18 years of age or older.
- •Adult Males and non-pregnant, non-lactating females.
- •Female subjects of childbearing potential must state that they are using measures to avoid conception through active means.
- •Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of palmar plantar pustulosis or which would increase their health risk by study participation.
- •Subjects must be willing to receive a 15 mg IM injection of Alefacept weekly for 16 weeks.
排除标准
- •Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- •Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
- •Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- •Any subject whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
- •Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
- •Treatment with psoralen + ultraviolet A (PUVA), systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
- •Ultraviolet B (UVB) phototherapy within 14 days prior to investigational drug administration.
- •Treatment within 7 days with topical agents (e.g. tar, anthralin, calcipotriol, tazarotene, steroids) which might have an effect on palmar plantar pustulosis.
- •Known HIV, Hepatitis B or C seropositivity or tuberculosis infection.
- •Significant abnormal chemistry, i.e. liver function tests greater than 3 times the upper limit of normal.
- •Allergy to Alefacept or any of the components of the formulation.
- •Known malignancy or history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence.)
- •Previous treatment with alefacept.
结局指标
主要结局
percentage change in PPPASI from baseline
次要结局
- number of subjects with PPPASI 75
- number of subjects with PPPASI 50
- number of subjects with very mild/clear PGA
- number of subjects with no pustules
研究者
研究点 (2)
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