NCT00488241

Brief Summary

To show efficacy of Zarzenda in the treatment of hand eczema

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

June 19, 2007

Last Update Submit

October 30, 2023

Conditions

Hand Eczema

Keywords

EczemaMedical device

Outcome Measures

Primary Outcomes (1)

  • Hand eczema severity index (HECSI)at the end of study

    End of study compared to baseline

Secondary Outcomes (4)

  • 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

Study Arms (1)

1

ACTIVE COMPARATOR

Topically applied daily for 2 weeks

Device: Zarzenda

Interventions

ZarzendaDEVICE

Topically applied daily for 2 weeks

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intendis GmbH

Berlin, Germany

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 20, 2007

Study Start

June 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

DE(1)