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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

June 19, 2007
December 3, 2007
June 2007
Not Provided
Hand eczema severity index (HECSI)at the end of study [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
Hand eczema severity index (HECSI)at the end of study [ Time Frame: End of study compared to baseline ]
Complete list of historical versions of study NCT00488241 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Investigator's Global Assessment [ Time Frame: End of study compared to baseline ]
  • Patients assessment of itch [ Time Frame: End of study compared to baseline ]
  • Hand surface area [ Time Frame: End of study compared to baseline ]
  • Clinical signs of hand eczema [ Time Frame: End of study compared to baseline ]
Not Provided
Not Provided
 
Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema
A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema

To show efficacy of Zarzenda in the treatment of hand eczema

The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hand Eczema
Device: Zarzenda
Topically applied daily for 2 weeks
Active Comparator: 1
Intervention: Device: Zarzenda
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00488241
1401663
No
Dr Markus Friedrich/Head, Global Clinical Development, Intendis GmbH
Intendis GmbH
Not Provided
Study Director: Markus Friedrich, Dr. Intendis GmbH
Intendis GmbH
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP