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

Phase 3

Completed

• Conditions: Uremic Xerosis

• Registration Number: NCT01084720
• Lead Sponsor: Orfagen

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2003-12
• Status Verified: 2010-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Last Update Submitted: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Posted: 2010-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Severity of uremic xerosis on the lower legs on day 7	7 days	Severity of uremic xerosis on the lower legs on day 7 by the investigator, using a defined 5-point severity scale. A therapeutic response was defined as a decrease of at least 2 grades of the xerosis after 7 days (end of phase I).

Secondary Outcome Measures

Name	Time	Method
Local tolerance of the test product and its vehicle and overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.	56 days