NCT00282724

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
9 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

1.2 years

First QC Date

January 20, 2006

Last Update Submit

September 23, 2011

Conditions

Ichthyosis, Lamellar

Keywords

Lamellar ichthyosisLiarozoleInvestigator's Global AssessmentScaling

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Investigator's Global Assessment

Secondary Outcomes (5)

  • Overall Scaling Score

  • Severity scores of other symptoms

  • Quality of Life

  • Safety and tolerability

  • Pharmacokinetics

Interventions

LiarozoleDRUG

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Academisch Ziekenhuis Vrije Universiteit Brussel

Brussels, Belgium

Location

Geel

Geel, Belgium

Location

Hôpital Saint-Justine

Montreal, Canada

Location

Newlab Clinical Research Inc.

St. John's, Canada

Location

Instituto Dermatologico

Santo Domingo, Dominican Republic

Location

Hôtel Dieu CHU

Nantes, France

Location

Tomesa Fachklinik

Bad Salzschlirf, Germany

Location

Dueren

Düren, Germany

Location

Otto-von-Guericke-Universität

Magdeburg, Germany

Location

University Hospital Muenster

Münster, Germany

Location

Fondazione Policlinico Mangiagalli e Regina Elena

Milan, Italy

Location

Istituto Dermopatico dell'Immacolata

Rome, Italy

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

University Hospital Rotterdam

Rotterdam, Netherlands

Location

Rikshospitalet Universitetsklinikk

Oslo, Norway

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (9)

  • 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.

    PMID: 2299598BACKGROUND

  • 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.

    PMID: 1374473BACKGROUND

  • 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.

    PMID: 8129749BACKGROUND

  • 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.

    PMID: 8757760BACKGROUND

  • 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.

    PMID: 8546999BACKGROUND

  • 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.

    PMID: 11122017BACKGROUND

  • 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.

    PMID: 11703279BACKGROUND

  • 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.

    PMID: 9039298BACKGROUND

  • 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.

    PMID: 24102348DERIVED

MeSH Terms

Conditions

Ichthyosis, Lamellar

Interventions

liarozole

Condition Hierarchy (Ancestors)

Ichthyosiform Erythroderma, CongenitalIchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Koen van Rossem, MD, PhD

    Barrier Therapeutics/ Stiefel, a GSK Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 27, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations

DO(1)BE(2)SE(1)IT(2)NL(2)FR(1)DE(4)NO(1)CA(2)