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

This study has been completed.
Sponsor:
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00488241
First received: June 19, 2007
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  Purpose

To show efficacy of Zarzenda in the treatment of hand eczema


Condition Intervention Phase
Hand Eczema
 Device: Zarzenda
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Eczema
U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:
  • Hand eczema severity index (HECSI)at the end of study [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's Global Assessment [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Patients assessment of itch [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Hand surface area [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Clinical signs of hand eczema [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: 1 Device: Zarzenda
Topically applied daily for 2 weeks

Detailed Description:

The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488241

Locations
Germany
Intendis GmbH
Berlin, Germany
Sponsors and Collaborators
Intendis GmbH
Investigators
Study Director: Markus Friedrich, Dr. Intendis GmbH
  More Information

Additional Information:
(Click here and search for drug information provided by the FDA)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Markus Friedrich/Head, Global Clinical Development, Intendis GmbH
ClinicalTrials.gov Identifier: NCT00488241     History of Changes
Obsolete Identifiers: NCT01646658
Other Study ID Numbers: 1401663
Study First Received: June 19, 2007
Last Updated: December 3, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Intendis GmbH:
Eczema
Medical device

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

ClinicalTrials.gov processed this record on May 23, 2013