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

February 15, 2015 updated by: Bayer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Zarzenda applied topically twice daily for three weeks
Device: Zarzenda
Topical cream, applied twice daily for three weeks
Active Comparator: 2
Elidel 1% cream, applied topically twice daily for three weeks
Drug: Elidel
1% cream, applied topically twice daily for three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator's Global Assessment
Time Frame: End of study compared to baseline
End of study compared to baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
EASI
Time Frame: End of study compared to baseline
End of study compared to baseline
Affected body surface area
Time Frame: End of study compared to baseline
End of study compared to baseline
Patient's assessment of itch, quality of sleep, and global assessment
Time Frame: End of study compared to baseline
End of study compared to baseline
Children's Dermatological Life Quality Index
Time Frame: End of study compared to baseline
End of study compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 15, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401920

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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