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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00568412
First received: December 3, 2007
Last updated: February 23, 2014
Last verified: February 2014

December 3, 2007
February 23, 2014
December 2007
September 2008   (final data collection date for primary outcome measure)
Investigator's Global Assessment [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00568412 on ClinicalTrials.gov Archive Site
  • EASI [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Affected body surface area [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Patient's assessment of itch, quality of sleep, and global assessment [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
  • Children's Dermatological Life Quality Index [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Mild to Moderate Atopic Dermatitis
  • Device: Zarzenda
    Topical cream, applied twice daily for three weeks
  • Drug: Elidel
    1% cream, applied topically twice daily for three weeks
  • Active Comparator: 1
    Zarzenda applied topically twice daily for three weeks
    Intervention: Device: Zarzenda
  • Active Comparator: 2
    Elidel 1% cream, applied topically twice daily for three weeks
    Intervention: Drug: Elidel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00568412
1401920
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP