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 (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00488241
First received: June 19, 2007
Last updated: February 25, 2014
Last verified: February 2014
  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: 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:


Further study details as provided by Bayer:

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
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Topically applied daily for 2 weeks
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00488241     History of Changes
Obsolete Identifiers: NCT01646658
Other Study ID Numbers: 1401663
Study First Received: June 19, 2007
Last Updated: February 25, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Eczema
Medical device

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

ClinicalTrials.gov processed this record on April 21, 2014