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

NCT ID: NCT00568412

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-09-30

Brief Summary

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

Detailed Description

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Conditions

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Mild to Moderate Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Zarzenda applied topically twice daily for three weeks

Group Type ACTIVE_COMPARATOR

Zarzenda

Intervention Type DEVICE

Topical cream, applied twice daily for three weeks

2

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

Group Type ACTIVE_COMPARATOR

Elidel

Intervention Type DRUG

1% cream, applied topically twice daily for three weeks

Interventions

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Zarzenda

Topical cream, applied twice daily for three weeks

Intervention Type DEVICE

Elidel

1% cream, applied topically twice daily for three weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1401920

Identifier Type: -

Identifier Source: org_study_id

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