Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282724
Status:
COMPLETED
Last Update Posted:
2011-09-26
First Post:
2006-01-20
Brief Title:
Efficacy and Safety of Two Doses of Liarozole vs Placebo for the Treatment of Lamellar Ichthyosis
Sponsor:
Stiefel a GSK Company
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase IIIII 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
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 300000 individuals Treatment is mainly symptomatic ie 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 IIIII study intends to evaluate the efficacy of liarozole compared with placebo in patients with lamellar ichthyosis
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 IIIII study intends to evaluate the efficacy of liarozole compared with placebo in patients with lamellar ichthyosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None