Non Erythrodermic Autosomic Recessive Lamellar Ichthyosis (NEARLI) Not Applicable Congenital ichthyosis
Conditions
Interventions
Study treatments:
Tazarotene cream 0.1% or 0.05% and vehicle.
Dose:
Period I (4 weeks): Patients will apply one of the two active test products and the vehicle on the lesions (except on face, scal
including face and neck). An adjusted dosage to local tolerance of test products will be performed (no test product application on irritated areas on days when they are observed).
Period II (8 weeks
application of the standard moisturiser only.
Mode of administration:
Topical
Sponsors
Orfagen (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes of at least 8 years of age 2. Patients with a documented diagnosis of LI based on clinical signs and, if possible, pedigree analysis 3. Patients with both scaling and roughness of moderate to severe intensity on each side of the body 4. Patients or patient's parents/guardians able to understand and follow the study procedures 5. Written informed consent from the patients or parents/guardians 6. Patients or patients' parents/guardians affiliated to a healthcare security system
Exclusion criteria
Exclusion criteria: 1. Patients under 8 years of age 2. 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 3. Women of childbearing potential with a positive systemic pregnancy test at baseline 4. Patients with congenital ichthyoses other than LI 5. Patients with an erythrodermic component of LI (EARLI) 6. Patients with LI of mild severity on at least one side of the body 7. Patients with lesional superinfection 8. Patients with skin or systemic disease likely to interfere with the study or the evaluation parameters 9. Patients with a known contact allergy to one of the ingredients contained in the test products 10. Patients with sunburn, or excessive pruritus, burning, skin redness or peeling, not fully recovered 11. Patients treated with topicals (e.g., vitamin A analogues, vitamin D analogues) within 14 days prior to baseline 12. Patients treated with keratolytics (e.g., urea, hydroxy-acids) or moisturizers other than the standard moisturizer within 7 days prior to baseline 13. Patients treated with concomitant dermatological medications and cosmetics that have a strong drying effect within 7 days prior to baseline 14. 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 15. 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 16. Patients treated with UV therapy or patients medically exposed to UV within 4 weeks prior to baseline 17. Patients having significant sun exposure due to their occupation 18. Patients with inherent sensitivity to sunlight 19. Patients who participated in a study within the 3 months prior to study entry 20. Patients living with a family member who is currently under test treatment, i.e. Period I of the study (from baseline to day 28) 21. Patients or patients' parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions 22. Patients or patients' parents/guardians who are unwilling to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of scaling and roughness by the investigator at each of the 10 visits (at screening, baseline, then on days 7, 14, 21, 28 [end of treatment, Period I], 42, 56, 70 and 84 [end of treatment-free follow-up, Period II]). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of the relapse/rebound by the investigator during Period II 2. Time-course severity of each sign (scaling and roughness) during Periods I and II 3. Separate assessment of the overall clinical severity of the lesions on palms and soles for each test side of the body at baseline and end of Period I 4. Assessment of the severity of scaling at baseline and end of Period I 5. Instrumental assessment of scaling on the two forearms using the D-squame technique, at baseline and end of Period I 6. Global local tolerance at end of Period I 7. Overall acceptability by the patients at end of Period I 8. Routine blood laboratory tests (hematology, chemistry) at baseline and at end of Period I 9. Plasma monitoring of tazarotenic acid at baseline and at end of Period I 10. Compliance 11. Physical examination 12. Adverse events | — |
Countries
France, Germany
Outcome results
None listed