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

Bayer

Status and phase: Completed; Phase 4

Conditions: Hand Eczema

Treatments: Device: Zarzenda

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488241

1401663

Details and patient eligibility

About

To show efficacy of Zarzenda in the treatment of hand eczema

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

1

Active Comparator group

Description:

Topically applied daily for 2 weeks

Treatment:

Device: Zarzenda