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

NCT ID: NCT00488241

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-09-30

Brief Summary

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To show efficacy of Zarzenda in the treatment of hand eczema

Detailed Description

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

Conditions

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Hand Eczema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Topically applied daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Zarzenda

Intervention Type DEVICE

Topically applied daily for 2 weeks

Interventions

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Zarzenda

Topically applied daily for 2 weeks

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Intendis GmbH

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1401663

Identifier Type: -

Identifier Source: org_study_id

NCT01646658

Identifier Type: -

Identifier Source: nct_alias

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