ong-term efficacy and safety of V0034 CR 01B cream in patients with moderate-to-severe uremic xerosis.

ORFAGE0 个研究点开始时间: 2007年12月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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 hemodialysis or peritoneal dialysis, due to chronic renal failure
•- Patients whose xerosis is related to their renal insufficiency status (uremic xerosis)
•- Patients suffering from xerosis with a severity score of at least 2, on at least one of the 5 tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck)
•- Written informed consent from the patients
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- 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 < 2 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/moisturizing topical preparation within the 7 days prior to study entry
•- Patients who participated in a study within the 3 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
•- Patients who refuse to give written informed consent

发起方

ORFAGE