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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00488241
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

To show efficacy of Zarzenda in the treatment of hand eczema

Condition or Disease	Intervention/Treatment	Phase
Hand Eczema	Device: Zarzenda	Phase 4

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
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Topically applied daily for 2 weeks	Device: Zarzenda; Topically applied daily for 2 weeks

Outcome Measures

Primary Outcome Measures

1. Hand eczema severity index (HECSI)at the end of study [End of study compared to baseline]

Secondary Outcome Measures

1. Investigator's Global Assessment [End of study compared to baseline]

2. Patients assessment of itch [End of study compared to baseline]

3. Hand surface area [End of study compared to baseline]

4. Clinical signs of hand eczema [End of study compared to baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intendis GmbH	Berlin		Germany

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00488241
• Other Study ID Numbers: 1401663; NCT01646658
• First Posted: Jun 20, 2007
• Last Update Posted: Feb 26, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Bayer: Eczema; Medical device
• Additional relevant MeSH terms: Eczema

Study Results

No Results Posted as of Feb 26, 2014