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

Mild to Moderate Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568412
• Other study ID #: 1401920
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2007
• Last updated: February 15, 2015
• Start date: December 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Mild to Moderate Atopic Dermatitis

Intervention

Device:
• Zarzenda
Topical cream, applied twice daily for three weeks

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

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Assessment		End of study compared to baseline	No
Secondary	EASI		End of study compared to baseline	No
Secondary	Affected body surface area		End of study compared to baseline	No
Secondary	Patient's assessment of itch, quality of sleep, and global assessment		End of study compared to baseline	No
Secondary	Children's Dermatological Life Quality Index		End of study compared to baseline	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for websynopsis information.