Status:
COMPLETED
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
Basilea Pharmaceutica
Conditions:
Eczema
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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. Conventiona...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2012
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00817063
Start Date
January 8 2009
End Date
April 26 2012
Last Update
April 27 2020
Active Locations (70)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
2
Radiant Research Inc.
Tucson, Arizona, United States, 85710
3
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
4
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205