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Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema

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ClinicalTrials.gov Identifier: NCT00488241
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To show efficacy of Zarzenda in the treatment of hand eczema

Condition or disease Intervention/treatment Phase
Hand Eczema Device: Zarzenda Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
Study Start Date : June 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Topically applied daily for 2 weeks
Device: Zarzenda
Topically applied daily for 2 weeks



Primary Outcome Measures :
  1. Hand eczema severity index (HECSI)at the end of study [ Time Frame: End of study compared to baseline ]

Secondary Outcome Measures :
  1. Investigator's Global Assessment [ Time Frame: End of study compared to baseline ]
  2. Patients assessment of itch [ Time Frame: End of study compared to baseline ]
  3. Hand surface area [ Time Frame: End of study compared to baseline ]
  4. Clinical signs of hand eczema [ Time Frame: End of study compared to baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488241


Locations
Germany
Intendis GmbH
Berlin, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00488241     History of Changes
Obsolete Identifiers: NCT01646658
Other Study ID Numbers: 1401663
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

Keywords provided by Bayer:
Eczema
Medical device

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous