Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Orfagen
- 入组人数
- 237
- 主要终点
- Treatment Response of Xerosis
研究概览
简要总结
Primary objective:
To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.
Secondary objectives:
- To assess the local tolerance of V0034 CR 01B after long-term use
- To assess the patient benefit and acceptability of V0034 CR 01B
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 —（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 18 years of age
- •Women of childbearing potential having a reliable contraceptive method
- •Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
- •Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
- •Patients suffering from xerosis with a severity score of at least two, on at least one of the five tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck)
排除标准
- •Patients under 18 years of age
- •Women with childbearing potential having a positive pregnancy test at baseline
- •Patients undergoing renal dialysis for another reason than chronic renal insufficiency
- •Patients whose xerosis is due to another reason than their MRD status
- •Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas)
- •Patients with a known history of allergy to one of the ingredients contained in the test product
- •Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
- •Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry
- •Patients who participated in a study within the three months prior to study entry
- •Patients who are not affiliated to health insurance
- •Patients who are not able or willing to follow the study instructions -
研究组 & 干预措施
V0034CR01B
cream
干预措施: V0034CR01B (Drug)
V0034 CR 01B vehicle
cream
干预措施: V0034CR01B vehicle (Drug)
结局指标
主要结局
Treatment Response of Xerosis
时间窗: 28 days
Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale: 0 = smooth skin 1. = patches of fine, powdery scales 2. = diffuse ashy appearance with many fine scales 3. = moderate scaling with beginning cracks 4. = intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I).
次要结局
- Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B(133 days)