Palliative treatment of uremic xerosis of moderate to severe intensity.
Conditions
Interventions
Trade Name: DEXERYL, crème en tube
Product Code: V0034 CR 01B
Pharmaceutical Form: Cream
INN or Proposed INN: Glycerol
CAS Number: 56-81-5
Concentration unit: % (W/W) percent weight/weight
Concentrati
Sponsors
ORFAGEN
Eligibility
Sex/Gender
All
Inclusion criteria
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 hemodialysis or peritoneal dialysis, due to chronic renal failure - Patients whose xerosis is related to their renal insufficiency status (uremic xerosis) - Patients suffering from xerosis with a severity score of at least 2, on at least one of the 5 tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck) - Written informed consent from the patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 < 2 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/moisturizing topical preparation within the 7 days prior to study entry - Patients who participated in a study within the 3 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 - Patients who refuse to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 uremic xerosis in the real-life setting.;Secondary Objective: -To assess the local tolerance of V0034 CR 01B after long-term use. -To assess the patient benefit and acceptability of V0034 CR 01B.;Primary end point(s): - Treatment response of 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 physician’s 5-point severity scale (Gammal et al., 1996). Treatment response will be 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 to relapse, as defined as the time up to which patients have at least one test area with a severity score of at least 2 during the treatment-free follow-up (Period II). Only patients with no persisting lesions on day 28 will be evaluated for this parameter. | — |
Countries
Germany, Greece, Hungary, Latvia
Outcome results
None listed