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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014