Back to resultsEfficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Primary Purpose
Hand Dermatoses
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
alitretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Hand Dermatoses focused on measuring Chronic Hand Dermatitis
Eligibility Criteria
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
Sites / Locations
- Thomas Ruzicka, MD
Outcomes
Primary Outcome Measures
Physicians global assessment
at week 12 or 24
Secondary Outcome Measures
Response rate per treatment group
Modified total lesion symptom score
Patients global assessment
at week 12 or 24
Time to relapse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00124475
Brief Title
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Official Title
Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Basilea Pharmaceutica
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Dermatoses
Keywords
Chronic Hand Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1035 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alitretinoin
Primary Outcome Measure Information:
Title
Physicians global assessment
Title
at week 12 or 24
Secondary Outcome Measure Information:
Title
Response rate per treatment group
Title
Modified total lesion symptom score
Title
Patients global assessment
Title
at week 12 or 24
Title
Time to relapse
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ruzicka, MD
Organizational Affiliation
University of Düsseldorf, Dermatological Hospital, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Ruzicka, MD
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15611422
Citation
Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.
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Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
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