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Completed

NCT Number: NCT00282724

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.

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Key information

Conditions

Ichthyosis, Lamellar Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Ichthyosiform Erythroderma, Congenital Ichthyosis Infant, Newborn, Diseases Keratosis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Academisch Ziekenhuis Vrije Universiteit Brussel, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects of either sex aged 14 years or older.
  • Clinical diagnosis of lamellar ichthyosis
  • Women of childbearing potential should use appropriate contraception
  • Women of childbearing potential should have a negative pregnancy test at screening visit.
  • Subjects are, except for their lamellar ichthyosis, in good general health.
  • Subjects and legal representative(s), if applicable, signed informed consent.

Exclusion criteria

  • Subject is receiving topical (except emollient), UV treatment or systemic treatment for ichthyosis.
  • Subject is pregnant or breast feeding.
  • History or suspicion of alcohol or drug abuse.
  • Significant co-existing diseases.
  • Clinically significant abnormal ECG
  • History of hypersensitivity to retinoids or any of the ingredients in the trial medication.
  • Clinically relevant laboratory abnormalities at screening.
  • Use of immune-suppressive drugs including topical or systemic corticosteroids.
  • Participation in an investigational trial 30 days prior to the start of the trial.

Treatment and study plan

Liarozole

Drug

Primary outcomes

  1. Efficacy: Investigator's Global Assessment

Secondary outcomes

  1. Overall Scaling Score

  2. Severity scores of other symptoms

  3. Quality of Life

  4. Safety and tolerability

  5. Pharmacokinetics

Sponsors and collaborators

Lead sponsor

Stiefel, a GSK Company

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 27, 2006
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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