Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema - NCT00817063-33409 (Clinical Trial 262377)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy262377.aspx
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| City: |
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West Palm Beach |
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State:
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FL |
| Zip Code: |
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33409 |
| Conditions: |
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Chronic Hand Eczema - Chronic Hand Dermatitis |
| Purpose: |
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The purpose of this study is to investigate the safety and efficacy of alitretinoin in the
treatment of severe chronic hand eczema that does not respond to treatment with potent
topical steroids.
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| Study summary: |
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Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for
dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from
labour market. Conventional treatments, including highly potent topical steroids, yield
often unsatisfactory results. This study investigates the efficacy and safety of oral
alitretinoin, a retinoid, in patients who have not responded to avoidance of causative
factors, such as contact allergens and skin irritants, non-medicated skin care and highly
potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or
a placebo. |
| Criteria: |
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Inclusion Criteria:
- all types of chronic hand eczema, lasting for at least 6 months since initial
diagnosis
- rated as severe by the physician
- unresponsive to highly potent topical corticosteroids, such as clobetasol
Exclusion Criteria:
- patients whose disease is adequately controlled by standard non-medicated therapy,
including potent topical steroids, skin moisturizers, and avoidance of allergens and
irritants
- patients with known allergens and irritants, who have not made a reasonable effort to
avoid the substances
- patients with psoriasis lesions
- active fungal, bacterial or viral infections of the hands
- female patients who are pregnant or breastfeeding
- female patients of childbearing potential who cannot use or will not commit to use
two effective methods of contraception |
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| Study is available at: |
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Palm Beach Research Center
West Palm Beach, FL 33409
United States
Primary Contact:
Abe Marcadis, MD
Phone: 561-689-0606
Secondary Contact:
Jürgen Maares, MD
Email: juergen.maares@basilea.com
Phone: +41 616061 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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