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

Study Overview
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Brief Summary
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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: To assess the local tolerance of V0034 CR 01B after long-term use To assess the patient benefit and acceptability of V0034 CR 01B

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

Conditions
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Uremic Xerosis

Intervention / Treatment
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* Drug: V0034CR01B
* Drug: V0034CR01B vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes, of at least 18 years of age Women of childbearing potential having a reliable contraceptive method Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis) 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: Patients under 18 years of age Women with childbearing potential having a positive pregnancy test at baseline Patients undergoing renal dialysis for another reason than chronic renal insufficiency Patients whose xerosis is due to another reason than their MRD status Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas) Patients with a known history of allergy to one of the ingredients contained in the test product Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry Patients who participated in a study within the three months prior to study entry Patients who are not affiliated to health insurance Patients who are not able or willing to follow the study instructions -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V0034CR01B<br>cream | Drug: V0034CR01B<br> <br> |
| Placebo Comparator: V0034 CR 01B vehicle<br>cream | Drug: V0034CR01B vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response of Xerosis | 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 = patches of fine, powdery scales = diffuse ashy appearance with many fine scales = moderate scaling with beginning cracks = 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). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B | 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 : = very satisfactory = satisfactory = poorly satisfactory = not satisfactory at all | 133 days |