Status:
COMPLETED
Efficacy and Safety of Two Doses of Liarozole vs. Placebo for the Treatment of Lamellar Ichthyosis
Lead Sponsor:
Stiefel, a GSK Company
Conditions:
Ichthyosis, Lamellar
Eligibility:
All Genders
14+ years
Phase:
PHASE2
PHASE3
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 retino...
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 consi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00282724
Start Date
January 1 2006
End Date
April 1 2007
Last Update
September 26 2011
Active Locations (16)
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1
Academisch Ziekenhuis Vrije Universiteit Brussel
Brussels, Belgium
2
Geel
Geel, Belgium
3
Hôpital Saint-Justine
Montreal, Canada
4
Newlab Clinical Research Inc.
St. John's, Canada