Multicenter Clinical Study to Examine the Efficacy and Sa... | NCT00488241

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

NCT00488241

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 31, 2023Actual

Enrollment

40Actual

Phase

Phase 4

Conditions

Hand Eczema

Interventions

Zarzenda

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Jun 19, 2007

First Submission Date that Met QC Criteria

Jun 19, 2007

First Posted Date

Jun 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2023

Last Update Posted Date

Oct 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Topically applied daily for 2 weeks	Device: Zarzenda

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zarzenda	Device	Topically applied daily for 2 weeks	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Investigator's Global Assessment		End of study compared to baseline
Patients assessment of itch		End of study compared to baseline
Hand surface area

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D004485	Eczema

Ancestor Terms

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous

Browse Leaves

Not provided

Browse Branches

Not provided