Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis

Orfagen

Status and phase

Completed

Phase 3

Conditions

Uremic Xerosis

Treatments

Drug: V0034 CR

Study type

Interventional

Funder types

Industry

Identifiers

V00034 CR 302 (ORF)

Details and patient eligibility

About

To evaluate the palliative effects of a moisturising emollient, in patients with uremic xerosis of moderate, severe or very severe intensity, associated or not to uremic pruritus.
To assess the local tolerance of the test product and its vehicle, and to evaluate the overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.

Enrollment

100 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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