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

October 30, 2023 updated by: Bayer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Intendis GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Topically applied daily for 2 weeks
Device: Zarzenda
Topically applied daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hand eczema severity index (HECSI)at the end of study
Time Frame: End of study compared to baseline
End of study compared to baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator's Global Assessment
Time Frame: End of study compared to baseline
End of study compared to baseline
Patients assessment of itch
Time Frame: End of study compared to baseline
End of study compared to baseline
Hand surface area
Time Frame: End of study compared to baseline
End of study compared to baseline
Clinical signs of hand eczema
Time Frame: End of study compared to baseline
End of study compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimated)

June 20, 2007

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401663

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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