A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis

Verified by: Intendis GmbH, September 2008
First Received: December 3, 2007 | Last Updated: September 29, 2008 | Phase: Phase 4 | Start Date: December 2007
Overall Status: Completed | Estimated Enrollment: 80
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To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic...

Brief Summary

Official Title: “A Multicenter, Randomized, Double-Blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents”

To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

  • Device: Zarzenda
    • Topical cream, applied twice daily for three weeks
  • Drug: Elidel
    • 1% cream, applied topically twice daily for three weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Zarzenda applied topically twice daily for three weeks
  • Active Comparator: 2
    • Elidel 1% cream, applied topically twice daily for three weeks

Outcome Measures for this Clinical Trial

Primary Measures

  • Investigator's Global Assessment
    • Time Frame: End of study compared to baseline
      Safety Issue?: No

Secondary Measures

  • EASI
    • Time Frame: End of study compared to baseline
      Safety Issue?: No
  • Affected body surface area
    • Time Frame: End of study compared to baseline
      Safety Issue?: No
  • Patient's assessment of itch, quality of sleep, and global assessment
    • Time Frame: End of study compared to baseline
      Safety Issue?: No
  • Children's Dermatological Life Quality Index
    • Time Frame: End of study compared to baseline
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • male and female children and adolescents (aged 2 - 17)
  • mild to moderate atopic dermatitis
  • patients in whom a treatment with topical corticosteroids in not recommended or possible
  • wash out periods to be observed

Exclusion Criteria:

  • known allergy to one of the two treatments
  • known immunodeficiency
  • known hepatic or renal insufficiency
  • acute skin infections

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Intendis GmbH Industry

Overall Clinical Trial Officials and Contacts

Thomas Bieber, Prof Principal Investigator Klinik und Poliklinik fuer Dermatologie, Universitaetsklinikum Bonn, Germany  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568412

Study ID Number: 1401920

ClinicalTrials.gov Identifier: NCT00568412

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00568412