Back to resultsAlitretinoin in the Treatment of Chronic Hand Eczema
Primary Purpose
Eczema
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
alitretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Eczema focused on measuring Chronic hand eczema, Chronic hand dermatitis, Patients with chronic hand eczema, who are refractory to topical corticosteroids
Eligibility Criteria
Inclusion Criteria:
- Previous participation in therapeutic trials involving chronic hand eczema
- Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score
Exclusion Criteria:
- Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy
Sites / Locations
Outcomes
Primary Outcome Measures
Safety assessments
Secondary Outcome Measures
Efficacy (Physicians Global Assessment)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519675
Brief Title
Alitretinoin in the Treatment of Chronic Hand Eczema
Official Title
Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Basilea Pharmaceutica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.
Detailed Description
Chronic hand eczema is a frequent and distressing disease. The course of the disease is of chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for patients with severe chronic hand eczema refractory to topical treatment. This study investigates the safety and efficacy of alitretinoin who previously have participated in a clinical trial involving alitretinoin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
Keywords
Chronic hand eczema, Chronic hand dermatitis, Patients with chronic hand eczema, who are refractory to topical corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alitretinoin
Primary Outcome Measure Information:
Title
Safety assessments
Secondary Outcome Measure Information:
Title
Efficacy (Physicians Global Assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous participation in therapeutic trials involving chronic hand eczema
Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score
Exclusion Criteria:
Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Maares, MD
Organizational Affiliation
Basilea Pharmaceutica
Official's Role
Study Director
Facility Information:
City
Paris
Country
France
City
Saint Etienne
Country
France
City
Berlin
Country
Germany
City
Dresden
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Alitretinoin in the Treatment of Chronic Hand Eczema
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