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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 3, 2007

Last Updated Date

September 29, 2008

Start Date ^†

December 2007

Current Primary Outcome Measures ^†

Investigator's Global Assessment [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00568412 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Mild to Moderate Atopic Dermatitis

Intervention ^†

Device: Zarzenda
Drug: Elidel

Study Arms / Comparison Groups

Active Comparator: Zarzenda applied topically twice daily for three weeks
Active Comparator: Elidel 1% cream, applied topically twice daily for three weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00568412

Responsible Party

Dr Ulrike Ebert/Medical Advisor, Intendis GmbH

Secondary IDs ^††

Study Sponsor ^†

Intendis GmbH

Collaborators ^††

Investigators ^†

Principal Investigator:

Thomas Bieber, Prof

Klinik und Poliklinik fuer Dermatologie, Universitaetsklinikum Bonn, Germany

Information Provided By

Intendis GmbH

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.