Study Completed

Hand Eczema

Bayer Identifier:

1401663

ClinicalTrials.gov Identifier:

NCT00488241

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

To show efficacy of Zarzenda in the treatment of hand eczema

Key Participants Requirements

Sex

Both

Age

18 Years

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

Trial summary

Enrollment Goal

Trial Dates

June 2007 - September 2007

Phase

Phase 4

Could I Receive a placebo

Products

Atopiclair (Zarzenda)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Intendis GmbH	Berlin, Germany

Primary Outcome

Hand eczema severity index (HECSI)at the end of study
Time Frame:
End of study compared to baseline
Safety Issue:
No

Secondary Outcome

Investigator's Global Assessment
Time Frame:
End of study compared to baseline
Safety Issue:
No
Patients assessment of itch
Time Frame:
End of study compared to baseline
Safety Issue:
No
Hand surface area
Time Frame:
End of study compared to baseline
Safety Issue:
No
Clinical signs of hand eczema
Time Frame:
End of study compared to baseline
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Device

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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