check_circleStudy Completed

Mild to Moderate Atopic Dermatitis

Bayer Identifier:

1401920

ClinicalTrials.gov Identifier:

NCT00568412

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

2 - 17 Years
  • - 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
  • - known allergy to one of the two treatments
    - known immunodeficiency
    - known hepatic or renal insufficiency
    - acute skin infections

Trial summary

Enrollment Goal
80
Trial Dates
December 2007 - September 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
Atopiclair (Zarzenda)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinik und Poliklinik fuer Dermatologie, UniverstitaetsklinikumBonn, 53105, Germany

Primary Outcome

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

Secondary Outcome

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

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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