check_circleStudy Completed

Hand Eczema

Bayer Identifier:

1401663

ClinicalTrials.gov Identifier:

NCT00488241

EudraCT Number:

Not Available

EU CT Number:

Not Available
Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema

Trial purpose

To show efficacy of Zarzenda in the treatment of hand eczema

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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 summary

Enrollment Goal
40
Trial Dates
June 2007 - September 2007
Phase
Phase 4
Could I Receive a placebo
No
Products
Atopiclair (Zarzenda)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Intendis GmbHBerlin, Germany

Primary Outcome

  • Hand eczema severity index (HECSI)at the end of study
    date_rangeTime Frame:
    End of study compared to baseline
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Investigator's Global Assessment
    date_rangeTime Frame:
    End of study compared to baseline
    enhanced_encryption
    Safety Issue:
    No
  • Patients assessment of itch
    date_rangeTime Frame:
    End of study compared to baseline
    enhanced_encryption
    Safety Issue:
    No
  • Hand surface area
    date_rangeTime Frame:
    End of study compared to baseline
    enhanced_encryption
    Safety Issue:
    No
  • Clinical signs of hand eczema
    date_rangeTime Frame:
    End of study compared to baseline
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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