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

Conditions: Palliative treatment of uremic xerosis of moderate to severe intensity.
MedDRA version: 9.1Level: LLTClassification code 10064130Term: Skin xerosis

Registration Number: EUCTR2006-002201-31-CZ

Lead Sponsor: ORFAGE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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