Back to resultsFollow-up Efficacy and Safety of Alitretinoin in 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 other trial for Hand Dermatoses focused on measuring Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed
Eligibility Criteria
Inclusion Criteria: Previous participation in protocol BAP089 Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease Exclusion Criteria: Female patients who are pregnant or who want to become pregnant Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception
Sites / Locations
- Thomas Ruzicka
Outcomes
Primary Outcome Measures
Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24
Secondary Outcome Measures
Patient's global assessment
Extent of disease
Time to respond
Modified total lesion symptom score
at week 12 or 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00124436
Brief Title
Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis
Official Title
Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Basilea Pharmaceutica
4. Oversight
5. Study Description
Brief Summary
Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to >75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Dermatoses
Keywords
Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alitretinoin
Primary Outcome Measure Information:
Title
Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24
Secondary Outcome Measure Information:
Title
Patient's global assessment
Title
Extent of disease
Title
Time to respond
Title
Modified total lesion symptom score
Title
at week 12 or 24
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:
Previous participation in protocol BAP089
Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease
Exclusion Criteria:
Female patients who are pregnant or who want to become pregnant
Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception
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
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.
Results Reference
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Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis
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