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

Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients Undergoing Maintenance Renal Dialysis With Uremic Xerosis (MRD)

• 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.

Study Overview

• Status: Completed
• Conditions: Uremic Xerosis
• Intervention / Treatment: Drug: V0034 CR

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of uremic xerosis on the lower legs on day 7	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).	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Orfagen
• Investigators: Principal Investigator: Jacek Szepietowski, Professor, DEPT. OF DERMATOLOGY, UNIVERSITY OF MEDICINE, UL. CHALUBINSKIEGO, POLAND

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Study Completion (Actual): December 1, 2003

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 10, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2010
• Last Update Submitted That Met QC Criteria: March 9, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Emollients; V0034CR
• Other Study ID Numbers: V00034 CR 302 (ORF)