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NCT Number: NCT00488241

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

To show efficacy of Zarzenda in the treatment of hand eczema

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Key information

Conditions

Hand Eczema Dermatitis Eczema Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intendis GmbH

Berlin, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zarzenda

Device

Topically applied daily for 2 weeks

Primary outcomes

  1. Hand eczema severity index (HECSI)at the end of study

    Time frame: End of study compared to baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 20, 2007
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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