- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124475
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
Study Overview
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 applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.
Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Düsseldorf, Germany, 40225
- Thomas Ruzicka, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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at week 12 or 24
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Physicians global assessment
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Secondary Outcome Measures
Outcome Measure |
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Time to relapse
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Modified total lesion symptom score
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at week 12 or 24
|
Response rate per treatment group
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Patients global assessment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Ruzicka, MD, University of Düsseldorf, Dermatological Hospital, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAP00089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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