Hand EczemaPhase 4NCT00488241
Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema
A Phase 4 study testing Zarzenda in people with Hand Eczema, run by Bayer at 1 site in Germany.
Trial summary
To show efficacy of Zarzenda in the treatment of hand eczema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Eczema
- What is being tested?
- Zarzenda
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
To show efficacy of Zarzenda in the treatment of hand eczema
Read the detailed description
The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.
- Conditions
- Hand Eczema
- Being tested
- Zarzenda
- Keywords
- Eczema, Medical device
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZarzendaDevice
Topically applied daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Topically applied daily for 2 weeks Receives: Device: Zarzenda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand eczema severity index (HECSI)at the end of study
Measured: End of study compared to baseline
Secondary outcomes (4)
Investigator's Global Assessment
Measured: End of study compared to baseline
Patients assessment of itch
Measured: End of study compared to baseline
Hand surface area
Measured: End of study compared to baseline
Clinical signs of hand eczema
Measured: End of study compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand EczemaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488241
- Sponsor's protocol ID
- 1401663
- Status last verified
- Oct 2023
- First submitted
- 19 Jun 2007
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
- ClinicalTrials.gov ID
- NCT00488241
- Acronym / sponsor ID
- 1401663
- Conditions
- Hand Eczema
- Keywords
- Eczema, Medical device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: ZarzendaTopically applied daily for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZarzendaTopically applied daily for 2 weeks | Device | 1 |
Primary outcome
Hand eczema severity index (HECSI)at the end of study
Time frame: End of study compared to baseline
4 secondary outcomes
Investigator's Global Assessment
Time frame: End of study compared to baseline
Patients assessment of itch
Time frame: End of study compared to baseline
Hand surface area
Time frame: End of study compared to baseline
Clinical signs of hand eczema
Time frame: End of study compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zarzenda in people with Hand Eczema, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand eczema severity index (HECSI)at the end of study (time frame: End of study compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.