Study 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

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

Trial summary

Enrollment Goal

Trial Dates

December 2007 - September 2008

Phase

Phase 4

Could I Receive a placebo

Products

Atopiclair (Zarzenda)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum	Bonn, 53105, Germany

Primary Outcome

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

Secondary Outcome

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

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

Additional Information

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