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

Orfagen (France)0 sites240 target enrollmentStarted: May 4, 2007Last updated: January 13, 2015

Conditions

Trial Snapshot

No summary available.

•1. Patients of both sexes, of at least 18 years of age
•2. Women of childbearing potential having a reliable contraceptive method
•3. Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
•4. Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
•5. 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)

•1. Patients under 18 years of age
•2. Women with childbearing potential having a positive pregnancy test at baseline
•3. Patients undergoing renal dialysis for another reason than chronic renal insufficiency
•4. Patients whose xerosis is due to another reason than their MRD status
•5. Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas)
•6. Patients with a known history of allergy to one of the ingredients contained in the test product
•7. Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
•8. Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry
•9. Patients who participated in a study within the three months prior to study entry
•10. Patients who are not affiliated to health insurance
•11. Patients who are not able or willing to follow the study instructions

Sponsor

Orfagen (France)