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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 parents/guardians able to understand and follow the study procedures,
-Written informed consent from the patients or parents/guardians,
-Patients or 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 (combined oral contraceptive, intra-uterine contraceptive device) and unwilling to use condoms, up to 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 with sunburn, or excessive pruritus, burning, skin redness or peeling, not fully recovered,
-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 concomitant dermatologic medications and cosmetics that have a strong drying effect 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 treated with drugs known to be photosensitizers (e.g. thiazides, tetracyclines, quinolones, phenothiazines, sulfonamides, hydrochlorates, chlorpromazine, psoralen, amiodarone, tar) within 2 weeks prior to baseline,
-Patients treated with UV therapy or patients medically exposed to UV within 4 weeks prior to baseline,
-Patients having significant sun exposure due to their occupation
-Patients with inherent sensitivity to sunlight,
-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 parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions,
-Patients or 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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