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

Phase 4

Completed

• Conditions: Hand Eczema
• Interventions: Device: Zarzenda

• Registration Number: NCT00488241
• Lead Sponsor: Bayer

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Zarzenda	Topically applied daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Hand eczema severity index (HECSI)at the end of study	End of study compared to baseline

Secondary Outcome Measures

Name	Time	Method
Investigator's Global Assessment	End of study compared to baseline
Clinical signs of hand eczema	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

Trial Locations

Locations (1)

Intendis GmbH; 🇩🇪 Berlin, Germany