MedDataX Logo

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

NCT ID: NCT00282724

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ichthyosis, Lamellar

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liarozole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stiefel, a GSK Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Koen van Rossem, MD, PhD

Role: STUDY_DIRECTOR

Barrier Therapeutics/ Stiefel, a GSK Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Academisch Ziekenhuis Vrije Universiteit Brussel

Brussels, , Belgium

Site Status

Geel

Geel, , Belgium

Site Status

Hôpital Saint-Justine

Montreal, , Canada

Site Status

Newlab Clinical Research Inc.

St. John's, , Canada

Site Status

Instituto Dermatologico

Santo Domingo, , Dominican Republic

Site Status

Hôtel Dieu CHU

Nantes, , France

Site Status

Tomesa Fachklinik

Bad Salzschlirf, , Germany

Site Status

Dueren

Düren, , Germany

Site Status

Otto-von-Guericke-Universität

Magdeburg, , Germany

Site Status

University Hospital Muenster

Münster, , Germany

Site Status

Fondazione Policlinico Mangiagalli e Regina Elena

Milan, , Italy

Site Status

Istituto Dermopatico dell'Immacolata

Rome, , Italy

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

University Hospital Rotterdam

Rotterdam, , Netherlands

Site Status

Rikshospitalet Universitetsklinikk

Oslo, , Norway

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Canada Dominican Republic France Germany Italy Netherlands Norway Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Van Wauwe JP, Coene MC, Goossens J, Cools W, Monbaliu J. Effects of cytochrome P-450 inhibitors on the in vivo metabolism of all-trans-retinoic acid in rats. J Pharmacol Exp Ther. 1990 Jan;252(1):365-9.

Reference Type BACKGROUND
PMID: 2299598 (View on PubMed)

Van Wauwe J, Van Nyen G, Coene MC, Stoppie P, Cools W, Goossens J, Borghgraef P, Janssen PA. Liarozole, an inhibitor of retinoic acid metabolism, exerts retinoid-mimetic effects in vivo. J Pharmacol Exp Ther. 1992 May;261(2):773-9.

Reference Type BACKGROUND
PMID: 1374473 (View on PubMed)

Van Wauwe J, Coene MC, Cools W, Goossens J, Lauwers W, Le Jeune L, Van Hove C, Van Nyen G. Liarozole fumarate inhibits the metabolism of 4-keto-all-trans-retinoic acid. Biochem Pharmacol. 1994 Feb 11;47(4):737-41. doi: 10.1016/0006-2952(94)90137-6.

Reference Type BACKGROUND
PMID: 8129749 (View on PubMed)

Kang S, Duell EA, Kim KJ, Voorhees JJ. Liarozole inhibits human epidermal retinoic acid 4-hydroxylase activity and differentially augments human skin responses to retinoic acid and retinol in vivo. J Invest Dermatol. 1996 Aug;107(2):183-7. doi: 10.1111/1523-1747.ep12329579.

Reference Type BACKGROUND
PMID: 8757760 (View on PubMed)

Dockx P, Decree J, Degreef H. Inhibition of the metabolism of endogenous retinoic acid as treatment for severe psoriasis: an open study with oral liarozole. Br J Dermatol. 1995 Sep;133(3):426-32. doi: 10.1111/j.1365-2133.1995.tb02672.x.

Reference Type BACKGROUND
PMID: 8546999 (View on PubMed)

Berth-Jones J, Todd G, Hutchinson PE, Thestrup-Pedersen K, Vanhoutte FP. Treatment of psoriasis with oral liarozole: a dose-ranging study. Br J Dermatol. 2000 Dec;143(6):1170-6. doi: 10.1046/j.1365-2133.2000.03884.x.

Reference Type BACKGROUND
PMID: 11122017 (View on PubMed)

Bhushan M, Burden AD, McElhone K, James R, Vanhoutte FP, Griffiths CE. Oral liarozole in the treatment of palmoplantar pustular psoriasis: a randomized, double-blind, placebo-controlled study. Br J Dermatol. 2001 Oct;145(4):546-53. doi: 10.1046/j.1365-2133.2001.04411.x.

Reference Type BACKGROUND
PMID: 11703279 (View on PubMed)

Lucker GP, Heremans AM, Boegheim PJ, van de Kerkhof PC, Steijlen PM. Oral treatment of ichthyosis by the cytochrome P-450 inhibitor liarozole. Br J Dermatol. 1997 Jan;136(1):71-5.

Reference Type BACKGROUND
PMID: 9039298 (View on PubMed)

Vahlquist A, Blockhuys S, Steijlen P, van Rossem K, Didona B, Blanco D, Traupe H. Oral liarozole in the treatment of patients with moderate/severe lamellar ichthyosis: results of a randomized, double-blind, multinational, placebo-controlled phase II/III trial. Br J Dermatol. 2014 Jan;170(1):173-81. doi: 10.1111/bjd.12626.

Reference Type DERIVED
PMID: 24102348 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BT0500INT001

Identifier Type: -

Identifier Source: org_study_id