E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To assess and compare the short-term efficacy of Tazarotene 0.05% and 0.1% vehicled in an emollient cream in LI patients. |
|
E.2.2 | Secondary objectives of the trial |
-To study the duration of lesional remission / relapse or rebound after test treatments. -To compare the global local tolerance of the test product at two different dosages. -To assess the systemic exposure to the active drug during initial treatment. -To compare the overall acceptability of the test products by the patient (efficacy, local tolerance, ease of use). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients of both sexes of at least 8 years of age, - Patients with a documented diagnosis of LI based on clinical signs and, if possible, pedigree analysis, - Patients with both scaling and roughness of moderate to severe intensity (scaling and roughness with a score of at least 2) on each side of the body, - Patients or patient’s parents/guardians able to understand and follow the study procedures, - Written informed consent from the patients or parents/guardians, - Patients or patients’ parents/guardians affiliated to a healthcare security system. |
|
E.4 | Principal exclusion criteria |
- Patients under 8 years of age, - Pregnant women, lactating mothers or women of childbearing potential with no reliable medical contraception (neither oral contraception, nor intra-uterine contraceptive device), - Women of childbearing potential unwilling to have a reliable contraception from the study enrollment to at least 8 weeks after the last test product application, - Women of childbearing potential with a positive systemic pregnancy test at baseline, - Patients with congenital ichthyoses other than LI, - Patients with an erythrodermic component of LI (EARLI), - Patients with LI of mild severity (score < 2 for scaling or roughness) on at least one side of the body, - Patients with lesional superinfection, - Patients with skin or systemic disease likely to interfere with the study or the evaluation parameters, - Patients with a known contact allergy to one of the ingredients contained in the test products, - Patients treated with topicals (e.g. vitamin A analogues, vitamin D analogues) within 14 days prior to baseline, - Patients treated with keratolytics (e.g. urea, hydroxy-acids) or moisturizers other than the standard moisturizer within 7 days prior to baseline, - Patients treated with oral retinoids during the preceding 28 days, or with oral vitamin A supplementation (more than 3000 IU per day) during the preceding 7 days of baseline, - Patients who participated in a study within the 3 months prior to study entry, - Patients living with a family member who is currently under test treatment, i.e. Period I of the study (from baseline to day 28), - Patients or patients’ parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions, - Patients or patients’ parents/guardians who are unwilling to give written informed consent. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Assessment of scaling and roughness by the investigators on two representative test areas of each test side of the body (of symmetrical locations for each patient), according to the following 4-point scale: 0 = Absent 1 = Mild 2 = Moderate 3 = Severe Severity grading of scaling will be illustrated in a photograder. Response will be defined by a score of 0 or 1 for each parameter (scaling and roughness), associated with a decrease from baseline of at least 2 points on scaling, at each time-point. |
|
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Intra-individual (left/right) comparaison |
|
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |