E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Palliative treatment of uremic xerosis of moderate to severe intensity. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064130 |
E.1.2 | Term | Skin xerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
-To assess the local tolerance of V0034 CR 01B after long-term use. -To assess the patient benefit and acceptability of V0034 CR 01B. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Periods I and II : randomised, double blind, two-parallel groups; Period III : open-labelled |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |