Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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