Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Test IGA
研究概览
简要总结
Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach.
The Main objective is to assess the efficacy of interferential current for treating palmoplantar psoriasis.
Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects.
详细描述
Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach.
Main objective To assess the efficacy of interferential current for treating palmoplantar psoriasis.
Secondary objectives To assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects.
Patients Patients from 18 to 90 year-old with psoriasis on the hands and/or feet. Length of the study: 12 months Methods Monocentric randomized comparative study versus placebo.Intervention V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria.
V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 18 to 90 year-old with psoriasis on the hands and/or feet diagnosed clinically
排除标准
- •Pregnant women,
- •implantable electronic device (such as pace maker), betabloquer.
- •Concomitant use of a treatment potentially active on psoriasis (steroids, vitamin D analogues, immunosuppressive drug, acitretin, cyclosporine, methotrexate, anti-TNF, anti-IL12/IL23).
结局指标
主要结局
Test IGA
时间窗: 12 weeks
IGA (investigator Global assessment) score from 0 (healed) to 4 (worst) at 12 and 24 weeks. The criteria of success will be IGA 0 or 1 at W12.
次要结局
- PGA (Patient global assessment)(12 weeks)
- PASI (Psoriasis Activity Severity Index)(12 weeks)
- NAPSI (Nail Activity Psoriasis Severity Index)(12 weeks)
研究者
Pr PASSERON
Professor
Association Niçoise Pour la Recherche En Dermatologie