Hand Eczema
Conditions
Keywords
Eczema, Medical device
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.
Interventions
DEVICEZarzenda
Topically applied daily for 2 weeks
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hand eczema severity index (HECSI)at the end of study | End of study compared to baseline |
Secondary
| Measure | 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 | End of study compared to baseline |
| Clinical signs of hand eczema | End of study compared to baseline |
Countries
Germany
Outcome results
None listed