Efficacy and Safety of Two Doses of Liarozole vs. Placebo for the Treatment of Lamellar Ichthyosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of 2 Doses of Oral Liarozole (75 mg od and 150 mg od) Given During 12 Weeks in Lamellar Ichthyosis|
- Efficacy: Investigator's Global Assessment
- Overall Scaling Score
- Severity scores of other symptoms
- Quality of Life
- Safety and tolerability
|Study Start Date:||January 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Lamellar ichthyosis is an autosomal recessive disorder that is apparent at birth and is present throughout life. Although the disorder is not life threatening, it is quite disfiguring and causes considerable psychological stress to affected patients. Prevalence is less than 1 case per 300,000 individuals. Treatment is mainly symptomatic i.e. emollients with or without keratolytic agents. Treatment with systemic retinoids is reserved for those patients, refractory to conventional therapy, because of the long-term adverse effects and teratogenicity of systemic retinoids.
Liarozole may provide a new concept for the treatment of this condition. Because of its mechanism of action, retinoic acid (RA) levels will only be increased in tissues that are targets for RA production.
The proposed Phase II/III study intends to evaluate the efficacy of liarozole compared with placebo, in patients with lamellar ichthyosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282724
|Academisch Ziekenhuis Vrije Universiteit Brussel|
|Newlab Clinical Research Inc.|
|St John, Canada|
|Santo Domingo, Dominican Republic|
|Hôtel Dieu CHU|
|Bad Salzschlirf, Germany|
|University Hospital Muenster|
|Fondazione Policlinico Mangiagalli e Regina Elena|
|Istituto Dermopatico dell'Immacolata|
|Academisch Ziekenhuis Maastricht|
|University Hospital Rotterdam|
|Uppsala University Hospital|
|Study Director:||Koen van Rossem, MD, PhD||Barrier Therapeutics/ Stiefel, a GSK Company|