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

September 23, 2011 updated by: Stiefel, a GSK Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Academisch Ziekenhuis Vrije Universiteit Brussel
      • Geel, Belgium
        • Geel
  • Canada
      • Montreal, Canada
        • Hôpital Saint-Justine
      • St John, Canada
        • NewLab Clinical Research Inc.
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Instituto Dermatológico
  • France
      • Nantes, France
        • Hôtel Dieu CHU
  • Germany
      • Bad Salzschlirf, Germany
        • Tomesa Fachklinik
      • Dueren, Germany
        • Dueren
      • Magdeburg, Germany
        • Otto-von-Guericke-Universität
      • Muenster, Germany
        • University Hospital Muenster
  • Italy
      • Milano, Italy
        • Fondazione Policlinico Mangiagalli e Regina Elena
      • Rome, Italy
        • Istituto Dermopatico dell'Immacolata
  • Netherlands
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
      • Rotterdam, Netherlands
        • University Hospital Rotterdam
  • Norway
      • Oslo, Norway
        • Rikshospitalet Universitetsklinikk
  • Sweden
      • Uppsala, Sweden
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy: Investigator's Global Assessment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiefel, a GSK Company

Investigators

  • Study Director: Koen van Rossem, MD, PhD, Barrier Therapeutics/ Stiefel, a GSK Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 25, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 26, 2011

Last Update Submitted That Met QC Criteria

September 23, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT0500INT001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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