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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00282724
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : September 26, 2011
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

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.

Condition or disease Intervention/treatment Phase
Ichthyosis, Lamellar Drug: Liarozole Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Efficacy: Investigator's Global Assessment

Secondary Outcome Measures :
  1. Overall Scaling Score
  2. Severity scores of other symptoms
  3. Quality of Life
  4. Safety and tolerability
  5. Pharmacokinetics

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00282724

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Academisch Ziekenhuis Vrije Universiteit Brussel
Brussels, Belgium
Geel, Belgium
Hôpital Saint-Justine
Montreal, Canada
Newlab Clinical Research Inc.
St John, Canada
Dominican Republic
Instituto Dermatologico
Santo Domingo, Dominican Republic
Hôtel Dieu CHU
Nantes, France
Tomesa Fachklinik
Bad Salzschlirf, Germany
Dueren, Germany
Magdeburg, Germany
University Hospital Muenster
Muenster, Germany
Fondazione Policlinico Mangiagalli e Regina Elena
Milano, Italy
Istituto Dermopatico dell'Immacolata
Rome, Italy
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
University Hospital Rotterdam
Rotterdam, Netherlands
Rikshospitalet Universitetsklinikk
Oslo, Norway
Uppsala University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Stiefel, a GSK Company
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Study Director: Koen van Rossem, MD, PhD Barrier Therapeutics/ Stiefel, a GSK Company

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stiefel, a GSK Company Identifier: NCT00282724    
Other Study ID Numbers: BT0500INT001
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011
Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
Lamellar ichthyosis
Investigator's Global Assessment
Additional relevant MeSH terms:
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Ichthyosis, Lamellar
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Skin Diseases
Ichthyosiform Erythroderma, Congenital
Skin Diseases, Genetic
Genetic Diseases, Inborn
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents