Back to resultsMulticenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema
Primary Purpose
Hand Eczema
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Zarzenda
Sponsored by
About this trial
This is an interventional treatment trial for Hand Eczema focused on measuring Eczema, Medical device
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate hand eczema for at least 3 months
- At least 4 weeks have passed since use of systemic treatment for eczema
- At least 4 weeks have passed since any vaccination
- At least 1 week has passed since last topic treatment on hands with corticosteroids
- Agree to use adequate contraceptive method if of childbearing potential
- Willingness to avoid excessive exposure to sunlight and avoid skin irritants
Exclusion Criteria:
- Pregnancy, breast feeding
- Severe excoriations on the hands
- Need for systemic treatment for atopic dermatitis
- Known sensitivity to Zarzenda and/or to extract of nut butyrospermum parkii (shea)
- Known immune deficiency
- Concomitant infection on hands
Sites / Locations
- Intendis GmbH
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Topically applied daily for 2 weeks
Outcomes
Primary Outcome Measures
Hand eczema severity index (HECSI)at the end of study
Secondary Outcome Measures
Investigator's Global Assessment
Patients assessment of itch
Hand surface area
Clinical signs of hand eczema
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00488241
Brief Title
Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema
Official Title
A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To show efficacy of Zarzenda in the treatment of hand eczema
Detailed Description
The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Eczema
Keywords
Eczema, Medical device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Topically applied daily for 2 weeks
Intervention Type
Device
Intervention Name(s)
Zarzenda
Intervention Description
Topically applied daily for 2 weeks
Primary Outcome Measure Information:
Title
Hand eczema severity index (HECSI)at the end of study
Time Frame
End of study compared to baseline
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment
Time Frame
End of study compared to baseline
Title
Patients assessment of itch
Time Frame
End of study compared to baseline
Title
Hand surface area
Time Frame
End of study compared to baseline
Title
Clinical signs of hand eczema
Time Frame
End of study compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate hand eczema for at least 3 months
At least 4 weeks have passed since use of systemic treatment for eczema
At least 4 weeks have passed since any vaccination
At least 1 week has passed since last topic treatment on hands with corticosteroids
Agree to use adequate contraceptive method if of childbearing potential
Willingness to avoid excessive exposure to sunlight and avoid skin irritants
Exclusion Criteria:
Pregnancy, breast feeding
Severe excoriations on the hands
Need for systemic treatment for atopic dermatitis
Known sensitivity to Zarzenda and/or to extract of nut butyrospermum parkii (shea)
Known immune deficiency
Concomitant infection on hands
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Intendis GmbH
City
Berlin
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema
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