NCT01084720已完成3 期
Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Orfagen
- 入组人数
- 100
- 主要终点
- Severity of uremic xerosis on the lower legs on day 7
研究概览
简要总结
- To evaluate the palliative effects of a moisturising emollient, in patients with uremic xerosis of moderate, severe or very severe intensity, associated or not to uremic pruritus.
- To assess the local tolerance of the test product and its vehicle, and to evaluate the overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, of at least 10 years of age
- •Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure
- •Patients whose xerosis is related to their renal insufficiency status
- •Patients suffering from moderate to severe xerosis, i.e. with a severity score of at least 2, on two symmetric areas of the lower legs (Phase I test areas)
- •Patients who have not experienced phototherapy within 8 weeks prior to study entry
- •Patients with no antipruritic treatment, or with stable antipruritic treatments (e.g. antihistamines, cholestyramine, opioid inhibitors, charcoal) at least 4 weeks before study entry
- •Written informed consent (Appendix II) from the patients or parents
排除标准
- •Patients under 10 years of age
- •Patients undergoing renal dialysis for another reason than MRD
- •Patients whose xerosis or pruritus is due to another reason than their MRD status
- •Patients suffering from mild xerosis (score £ 1) on the lower legs
- •Patients with xerosis of non comparable severity between the lower legs
- •Patients with a known history of allergy to one of the ingredients contained in the test product
- •Patient with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
- •Patients treated with any other emollient/moisturizing topical preparation within the 7 days prior to study entry
- •Patients with phototherapy within 8 weeks prior to study entry
- •Patients who started an antipruritic treatment other than phototherapy, or who experienced unstable dosage schedule of antipruritic treatments (e.g. antihistamines, cholestyramin, opiod inhibitors, charcoal) within 4 weeks prior to study entry
- •Patients who participated in a study within the 3 months prior to study entry
- •Patients who are not able or willing to follow the study instructions
- •Patients or parents who refuse to give written informed consent
结局指标
主要结局
Severity of uremic xerosis on the lower legs on day 7
时间窗: 7 days
Severity of uremic xerosis on the lower legs on day 7 by the investigator, using a defined 5-point severity scale. A therapeutic response was defined as a decrease of at least 2 grades of the xerosis after 7 days (end of phase I).
次要结局
- Local tolerance of the test product and its vehicle and overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.(56 days)
研究者
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