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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
237
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 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).
Time frame: 28 days
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 : 1. = very satisfactory 2. = satisfactory 3. = poorly satisfactory 4. = not satisfactory at all
Time frame: 133 days
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