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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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.


Sponsor: Stiefel, a GSK Company

Current Primary Outcome: Efficacy: Investigator's Global Assessment

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Scaling Score
  • Severity scores of other symptoms
  • Quality of Life
  • Safety and tolerability
  • Pharmacokinetics


Original Secondary Outcome:

  • Efficacy:
  • • Overall Scaling Score
  • • Severity scores of other symptoms
  • • Quality of Life
  • Safety and tolerability
  • Pharmacokinetics


Information By: GlaxoSmithKline

Dates:
Date Received: January 20, 2006
Date Started: January 2006
Date Completion:
Last Updated: September 23, 2011
Last Verified: September 2011