Ichthyosis, Lamellar Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00074685 -
National Registry for Ichthyosis and Related Disorders
|