Vesicular Palmoplantar EczemaNCT00442091
Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema
A study testing dandelion juice in people with Vesicular Palmoplantar Eczema and Pompholyx, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that ingestion of dandelion juice could induce a beneficial effect on this type of eczema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vesicular Palmoplantar Eczema, Pompholyx
- What is being tested?
- dandelion juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to Dec 2019
- Phase
- Interventional
- 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
- Adult patients with dyshidrotic eczema for at least 1 year and negative patch test reactions to Compositae (tested within the last 3 years) and normal renal and hepatic blood tests.
Who cannot join
- Treatment with systemic steroids or other immunosuppressive/-modulating drugs, including UV therapy, within the last 3 months.
- Pregnancy, lactation.
- Compositae contact allergy.
- Liver or gall bladder disease.
- Abnormal renal or hepatic blood tests.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology, Odense University Hospital
Odense, DK-5000
About this study
Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that ingestion of dandelion juice could induce a beneficial effect on this type of eczema. The purpose of this study is to test whether this effect can be retrieved in other patients.
Read the detailed description
Dandelion juice has been used in herbal medicine for at least 1000 years. One case report has shown a beneficial effect of this herbal remedy on dyshidrotic hand eczema, and the purpose of this pilot study is to test whether this effect can be retrieved in other patients.
The patients are recruited from our out-patient clinic. Only patients with negative patch tests to Compositae are offered treatment with dandelion juice for 20-30 days.
- Conditions
- Vesicular Palmoplantar Eczema, Pompholyx
- Being tested
- dandelion juice
- Keywords
- Dandelion, herbal remedy, hand eczema, Compositae
- Medical subject headings
- Eczema, Dyshidrotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dandelion juiceDrug
10 ml bid for 20-30 days
| Study group | Role | What they receive |
|---|---|---|
| 10 ml of dandelion juice twice daily | Other | Not described Receives: Drug: dandelion juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in dyshidrotic hand eczema in the study period assessed by HECSI score.
Measured: 3-4 weeks
Secondary outcomes (1)
Improvement in dyshidrotic eczema in the study period assessed by the patient (Visual Analog Scale).
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startDec 2010
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicular Palmoplantar EczemaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evy Paulsen, Odense University Hospital
- Investigators
- Evy Paulsen, Dr., Principal investigator, Department of Dermatology, Odense University Hospital, DK-5000 Odense C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442091
- Sponsor's protocol ID
- 20070010
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2007
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema
- ClinicalTrials.gov ID
- NCT00442091
- Acronym / sponsor ID
- 20070010
- Conditions
- Vesicular Palmoplantar Eczema, Pompholyx
- Keywords
- Dandelion, herbal remedy, hand eczema, Compositae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Mar 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.
Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that ingestion of dandelion juice could induce a beneficial effect on this type of eczema. The purpose of this study is to test whether this effect can be retrieved in other patients.
Detailed description
Dandelion juice has been used in herbal medicine for at least 1000 years. One case report has shown a beneficial effect of this herbal remedy on dyshidrotic hand eczema, and the purpose of this pilot study is to test whether this effect can be retrieved in other patients.
The patients are recruited from our out-patient clinic. Only patients with negative patch tests to Compositae are offered treatment with dandelion juice for 20-30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10 ml of dandelion juice twice daily | Other | Drug: dandelion juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with dyshidrotic eczema for at least 1 year and negative patch test reactions to Compositae (tested within the last 3 years) and normal renal and hepatic blood tests.
Key exclusion criteria (5 listed)
- Treatment with systemic steroids or other immunosuppressive/-modulating drugs, including UV therapy, within the last 3 months.
- Pregnancy, lactation.
- Compositae contact allergy.
- Liver or gall bladder disease.
- Abnormal renal or hepatic blood tests.
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 |
|---|---|---|
| dandelion juice10 ml bid for 20-30 days | Drug | 10 ml of dandelion juice twice daily |
Primary outcome
Improvement in dyshidrotic hand eczema in the study period assessed by HECSI score.
Time frame: 3-4 weeks
1 secondary outcome
Improvement in dyshidrotic eczema in the study period assessed by the patient (Visual Analog Scale).
Time frame: 3-4 weeks
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 4 Mar 2020.
- Individual participant dataSharing planned: No
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.
Evy Paulsen, Dr. principal investigator
Department of Dermatology, Odense University Hospital, DK-5000 Odense C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dandelion juice in people with Vesicular Palmoplantar Eczema and Pompholyx, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 5 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 4 Mar 2020. 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 Denmark. 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.
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?
Improvement in dyshidrotic hand eczema in the study period assessed by HECSI score. (time frame: 3-4 weeks). 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 4 Mar 2020.