Efficacy and tolerance of Tazarotene cream in lamellar ichthyosis (LI): a dose-finding study.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 32

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

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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