Status:
COMPLETED
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Hand Dermatoses
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.
Detailed Description
Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all application...
Eligibility Criteria
Inclusion
- Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
- Lasting for 6 months since initial diagnosis
- Rated severe
- Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
- Refractory to topical steroids
Exclusion
- Female patients who are pregnant or want to become pregnant
- Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
- Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
1035 Patients enrolled
Trial Details
Trial ID
NCT00124475
Start Date
December 1 2004
End Date
September 1 2007
Last Update
May 10 2023
Active Locations (1)
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1
Thomas Ruzicka, MD
Düsseldorf, Germany, 40225