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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: December 3, 2007
Last updated: February 15, 2015
Last verified: February 2015
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis

Condition Intervention Phase
Mild to Moderate Atopic Dermatitis
Device: Zarzenda
Drug: Elidel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Investigator's Global Assessment [ Time Frame: End of study compared to baseline ]

Secondary Outcome Measures:
  • EASI [ Time Frame: End of study compared to baseline ]
  • Affected body surface area [ Time Frame: End of study compared to baseline ]
  • Patient's assessment of itch, quality of sleep, and global assessment [ Time Frame: End of study compared to baseline ]
  • Children's Dermatological Life Quality Index [ Time Frame: End of study compared to baseline ]

Enrollment: 80
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Zarzenda applied topically twice daily for three weeks
Device: Zarzenda
Topical cream, applied twice daily for three weeks
Active Comparator: 2
Elidel 1% cream, applied topically twice daily for three weeks
Drug: Elidel
1% cream, applied topically twice daily for three weeks


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00568412

Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
Bonn, Germany, 53105
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00568412     History of Changes
Other Study ID Numbers: 1401920
Study First Received: December 3, 2007
Last Updated: February 15, 2015

Keywords provided by Bayer:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017