Efficacy and Safety of Two Doses of Liarozole vs. Placebo for the Treatment of Lamellar Ichthyosis

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Lamellar ichthyosis is a congenital disease of the skin with a generalized scaling. The primary activity of liarozole is considered to be the inhibition of the degradation of a substance called retinoic acid, which is the principal endogenous regulator of growth and differentiation of epithelial tissues in mammals. The current study intends to evaluate the efficacy and safety in patients with lamellar ichthyosis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Treatments: Liarozole

Criteria

Inclusion Criteria:

• Subjects of either sex aged 14 years or older.

• Clinical diagnosis of lamellar ichthyosis

• Women of childbearing potential should use appropriate contraception

• Women of childbearing potential should have a negative pregnancy test at screening visit.

• Subjects are, except for their lamellar ichthyosis, in good general health.

• Subjects and legal representative(s), if applicable, signed informed consent.

Exclusion Criteria:

• Subject is receiving topical (except emollient), UV treatment or systemic treatment for ichthyosis.

• Subject is pregnant or breast feeding.

• History or suspicion of alcohol or drug abuse.

• Significant co-existing diseases.

• Clinically significant abnormal ECG

• History of hypersensitivity to retinoids or any of the ingredients in the trial medication.

• Clinically relevant laboratory abnormalities at screening.

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

• Participation in an investigational trial 30 days prior to the start of the trial.