Lamellar Ichthyosis (LI)
Conditions
Interventions
Trade Name: Tazorac®
Product Name: Tazarotene
Product Code: R0002 CR 01A
Pharmaceutical Form: Cream
INN or Proposed INN: TAZAROTENE
CAS Number: 118292403
Other descriptive name: Ethyl 6-[2-(4,4-dimet
Sponsors
Orfagen
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess and compare the short-term efficacy of Tazarotene 0.05% and 0.1% vehicled in an emollient cream in LI patients.;Secondary Objective: -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).;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. | — |
Countries
France, Germany
Outcome results
None listed