Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in fluid retention at day 30
研究概览
简要总结
Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.
详细描述
The main objective of the study is to evaluate whether there is fluid retention after introduction of clobetasol propionate treatment from 10 g/day dosage to 40 g / day in patients with bullous pemphigoid. Bio-impedance is a noninvasive device for measuring with an electric current of low intensity the different volumes of the human body. A preliminary experiment of impedance measurements in some patients with bullous pemphigoid (examination requested as part of a nutritional assessment) showed that these patients had mostly a total water loss without dehydration, corresponding to a significant undernutrition during 1 month of treatment, possibly related to muscle wasting and protein loss by skin erosions without obvious argument for fluid retention, justifying reproduce these measures on a larger number of patients and the other to accurately assess the evolution of nutritional parameters during the first month of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patient with age higher than 18
- •Patient with bullous pemphigoid,
- •Patient treated by local corticosteroid therapy (clobetasol propionate cream) but not yet processed or for less than 48 hours,
- •Signed informed consent.
- •Patient affiliated to Social Security Regimen
- •Effective contraception in women of childbearing age (for postmenopausal women, confirmatory diagnosis of menopause will be collected)
排除标准
- •Concomitant treatment with corticosteroids
- •Recent introduction or recent (<6 weeks) treatment with diuretics, angiotensin-converting enzyme, receptor antagonist or anti-angiotensin renin (aliskiren)
- •contraindication to the use of Clobetasol propionate (DERMOVAL and CLARELUX)
- •Patient on salt diet (<or = to 5 g / d)
- •Patients carry a defibrillator or a pace maker
- •Amputated Patient
- •Pregnant and lactating
- •Patient with Urinary Incontinency
- •Recent heart decompensation in the last 6 weeks
- •known Nephrotic Syndrome
- •known or Severe hepatic impairment
- •Hypoalbuminaemia less than 20 g / l
研究组 & 干预措施
Bullous pemphigoid patient treated with clobetasol propionate
Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.
干预措施: Impedance analysis (Procedure)
Bullous pemphigoid patient treated with clobetasol propionate
Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.
干预措施: Clobetasol Propionate cream treatment (Drug)
结局指标
主要结局
Change from Baseline in fluid retention at day 30
时间窗: Day 30
Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis
次要结局
- Urinary Sodium level variation between day 1 and day 30(Day 30)
- Brain Natriuretic Peptide level variation between day 1 and day 30(Day 30)
- Urinary creatinin level variation between day 1 and day 30(Day 30)
- Change from Baseline in fluid retention at day 7(Day 7)
- Weight variation between day 1 and day 30(Day 30)
- Change from Baseline in nutritional parameters at day 30(Day 30)
- Change from Baseline in bullous pemphigoid disease severity index at day 30(Day 30)
- Change from Baseline in bullous pemphigoid disease severity index at day 7(Day 7)
- Change from Baseline in corticoid administration dosage at days 30(Day 30)