Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Number of Participants with PASI score improvement as a Measure of effective treatment
研究概览
简要总结
Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission.
The investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe psoriasis: At least 30% of body involved) according to the rule of nine.
- •Resistance to conventional therapy (PUVA, methotrexate, retinoids):
- •(Maximum PASI 50% improvement while on treatment for a duration not less than 6 months).
- •Immunologically competent individuals with
- •Seropositive for the varicella antibodies
排除标准
- •Any contraindication to live attenuated varicella vaccine
- •Any contraindication to cyclosporine
研究组 & 干预措施
chicken pox vaccine, efficacy
干预措施: live attenuated chicken pox vaccine (Drug)
saline, efficacy
干预措施: saline, efficacy (Drug)
结局指标
主要结局
Number of Participants with PASI score improvement as a Measure of effective treatment
时间窗: 12 weeks
the clinical evaluation of our patients through the Psoriasis Area Severity Index (PASI) score calculation at each visit. The final patient's response was rated according to the physician global assessment (PGA) based on the final improvement of the PASI score as worse, poor (0-24% improvement in PASI), fair (25-50% improvement in PASI), good (50-74% improvement in PASI), excellent (75-99% improvement in PASI), or cleared (100% improvement in PASI).
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(12 weeks)