A randomized, double-blind, multinational, multicenter, placebo-controlled parallel phase II/III trial to evaluate the efficacy and safety of 2 doses of oral liarozole (75 mg o.d. and 150 mg o.d.) given during 12 weeks in comparison with placebo in the treatment of subjects with lamellar ichthyosis. - Efficacy and safety of two doses of liarozole vs. placebo for the treatment of lamellar ichthyosis.

• Conditions: amellar Ichthyosis; MedDRA version: 8.1Level: LLTClassification code 10023686Term: Lamellar ichthyosis

• Registration Number: EUCTR2005-000842-35-DE
• Lead Sponsor: Barrier Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Subjects of either sex aged 18 years or older

2. Clinical diagnosis of lamellar ichthyosis with at visits 1 and 2 an Investigator’s Global Assessment of at least 3 when defined as follows:
Investigator’s global assessment of the overall severity of subject’s lamellar ichthyosis at a particular time point, taking into consideration the two individual characteristics of ichthyosis (scaling and/or erythema), measured by the following 5-point Likert scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe).

3. Women of childbearing potential are asked to use simultaneously 2 forms of effective contraception during the trial. The first one must be a hormonal contraceptive containing an association of progestin and estrogen and must be taken for at least 1 month (full cycle) before the start of treatment (visit 2). The second one must be a barier method with spermicide and must be used at least from visit 1. Both forms must then be used during treatment and until one month after the end of the treatment period.

4. Women of childbearing potential should have a negative pregnancy test at screening visit (Visit 1), confirmed by another pregnancy test at Visit 2 before randomization.

5. Subjects wearing contact lenses must agree not to wear their lenses and to use glasses when necessary for the entire treatment period.

6. Subjects are, except for their lamellar ichthyosis, in good general health and free of any disease state or physical condition that, in the investigator’s opinion, might impair evaluation of their lamellar ichthyosis.

7. Subjects signed informed consent.
Are the trial subjects under 18? no
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

1. Concurrent inflammatory skin disease unrelated to ichthyosis.

2. Subject is receiving topical (except emollient) or UV treatment for ichthyosis in the 2 weeks prior to the start of treatment (Visit 2).

3. Subject is receiving systemic therapy for ichthyosis in the 4 weeks prior to the start of treatment (Visit 2).

4. Subject is pregnant or breast feeding.

5. History or suspicion of alcohol or drug abuse.

6. Significant co-existing hepatic, renal, immune disease, chronic pancreatitis, osteoporosis or a history indicating adrenal cortex dysfunction.

7. Heart disorder requiring treatment, or a myocardial infarction within the previous 24 weeks or a history of heart-failure or clinically relevant cardiac arrhythmia.

8. Clinically significant abnormal electrocardiogram-intervals or morphology of the electrocardiogram; QT or QTc >470 ms in women or >450 ms in men.

9. Subjects with risk factors for a QT/QTc prolongation (cardiac insufficiency, hypokalemia, a family history of long QT syndrome).

10. History of hypersensitivity to retinoids.

11. History of hypersensitivity to any of the ingredients in the trial medication.

12. Clinically relevant laboratory abnormalities at screening, especially levels of blood triglycerides, cholesterol and liver function parameters.

13. Use of Vitamin A supplements in the 4 weeks prior to the start of treatment or during the trial.

14. Use of disallowed drugs, mainly drugs metabolized by the CYP450 system during the treatment period.

15. Use of immune-suppressive drugs including topical or systemic corticosteroids.

16. Participation in an investigational trial 30 days prior to the start of the trial (Visit 1).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified