Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

Phase 3

Completed

• Conditions: Uremic Xerosis
• Interventions: Drug: V0034CR01B; Drug: V0034CR01B vehicle

• Registration Number: NCT01084148
• Lead Sponsor: Orfagen

Brief Summary

Primary objective:

To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.

Secondary objectives:

1. To assess the local tolerance of V0034 CR 01B after long-term use

2. To assess the patient benefit and acceptability of V0034 CR 01B

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Results First Submitted: 2014-01-31
• Results First Submitted QC: 2014-01-31
• Results First Posted: 2014-03-18
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-24
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

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)

Exclusion Criteria

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V0034CR01B	V0034CR01B	cream
V0034 CR 01B vehicle	V0034CR01B vehicle	cream

Primary Outcome Measures

Name	Time	Method
Treatment Response of Xerosis	28 days	Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale: 0 = smooth skin; 1. = patches of fine, powdery scales; 2. = diffuse ashy appearance with many fine scales; 3. = moderate scaling with beginning cracks; 4. = intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I).

Secondary Outcome Measures

Name	Time	Method
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	133 days	At the end of treatment (day 133), patients assessed their overall agreement on the local tolerance of the test product, using a 4-point scale, as follows : 1. = very satisfactory; 2. = satisfactory; 3. = poorly satisfactory; 4. = not satisfactory at all