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Clinical Trials/NCT00488241
NCT00488241CompletedPhase 4

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

Bayer1 site in 1 country40 target enrollmentStarted: June 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Bayer
Enrollment
40
Locations
1
Primary Endpoint
Hand eczema severity index (HECSI)at the end of study
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To show efficacy of Zarzenda in the treatment of hand eczema

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: End of study compared to baseline

Secondary Outcomes

  • Clinical signs of hand eczema(End of study compared to baseline)
  • Investigator's Global Assessment(End of study compared to baseline)
  • Patients assessment of itch(End of study compared to baseline)
  • Hand surface area(End of study compared to baseline)

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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