Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema

• ClinicalTrials.gov Identifier: NCT00442091
• Recruitment Status: Completed
• First Posted: March 1, 2007
• Last Update Posted: March 4, 2020
• Sponsor: Odense University Hospital
• Information provided by (Responsible Party): Evy Paulsen, Odense University Hospital

Tracking Information

• First Submitted Date: February 28, 2007
• First Posted Date: March 1, 2007
• Last Update Posted Date: March 4, 2020
• Study Start Date: December 2010
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 21, 2011): Improvement in dyshidrotic hand eczema in the study period assessed by HECSI score. [ Time Frame: 3-4 weeks ]
• Original Primary Outcome Measures (submitted: February 28, 2007): Improvement of dyshidrotic hand eczema in the study period.
• Current Secondary Outcome Measures (submitted: July 21, 2011): Improvement in dyshidrotic eczema in the study period assessed by the patient (Visual Analog Scale). [ Time Frame: 3-4 weeks ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema
• Official Title: Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema
• Brief 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. 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Vesicular Palmoplantar Eczema
• Pompholyx

Intervention

Drug: dandelion juice

10 ml bid for 20-30 days

Study Arms

10 ml of dandelion juice twice daily

Intervention: Drug: dandelion juice

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2007): 4
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2019
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00442091
• Other Study ID Numbers: 20070010
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Evy Paulsen, Odense University Hospital
• Original Responsible Party: Not Provided
• Current Study Sponsor: Odense University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Evy Paulsen, Dr.; Department of Dermatology, Odense University Hospital, DK-5000 Odense C

• PRS Account: Odense University Hospital
• Verification Date: March 2020