Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Barrier Therapeutics |
---|---|
Information provided by: | Barrier Therapeutics |
ClinicalTrials.gov Identifier: | NCT00282724 |
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.
Condition | Intervention | Phase |
---|---|---|
Ichthyosis, Lamellar |
Drug: Liarozole |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 98 |
Study Start Date: | January 2006 |
Study Completion Date: | April 2007 |
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.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Academisch Ziekenhuis Vrije Universiteit Brussel | |
Brussels, Belgium | |
Geel | |
Geel, Belgium | |
Canada | |
Hôpital Saint-Justine | |
Montreal, Canada | |
Newlab Clinical Research Inc. | |
St John, Canada | |
Dominican Republic | |
Instituto Dermatologico | |
Santo Domingo, Dominican Republic | |
France | |
Hôtel Dieu CHU | |
Nantes, France | |
Germany | |
Dueren | |
Dueren, Germany | |
Otto-von-Guericke-Universität | |
Magdeburg, Germany | |
Tomesa Fachklinik | |
Bad Salzschlirf, Germany | |
University Hospital Muenster | |
Muenster, Germany | |
Italy | |
Istituto Dermopatico dell'Immacolata | |
Rome, Italy | |
Fondazione Policlinico Mangiagalli e Regina Elena | |
Milano, Italy | |
Netherlands | |
University Hospital Rotterdam | |
Rotterdam, Netherlands | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands | |
Norway | |
Rikshospitalet Universitetsklinikk | |
Oslo, Norway | |
Sweden | |
Uppsala University Hospital | |
Uppsala, Sweden |
Study Director: | Koen van Rossem, MD, PhD | Barrier Therapeutics |
Study ID Numbers: | BT0500INT001 |
Study First Received: | January 20, 2006 |
Last Updated: | September 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00282724 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Italy: The Italian Medicines Agency; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Canada: Health Canada |
Lamellar ichthyosis Liarozole Investigator's Global Assessment Scaling |
Keratosis Liarozole Skin Diseases Keratosis follicularis spinulosa decalvans Skin Abnormalities Dermatitis, Exfoliative Lamellar ichthyosis Ichthyosis |
Exfoliative dermatitis Genetic Diseases, Inborn Infant, Newborn, Diseases Ichthyosis, Lamellar Congenital Abnormalities Skin Diseases, Genetic Tylosis Ichthyosiform erythroderma, nonbullous congenital |
Androgen Antagonists Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Hormone Antagonists |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Dermatologic Agents Pharmacologic Actions Ichthyosiform Erythroderma, Congenital |