Skip to main content
OpenTrials
Completed

NCT Number: NCT00568412

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild to Moderate Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum

Bonn, 53105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zarzenda

Device

Topical cream, applied twice daily for three weeks

Elidel

Drug

1% cream, applied topically twice daily for three weeks

Primary outcomes

  1. Investigator's Global Assessment

    Time frame: End of study compared to baseline

Secondary outcomes

  1. EASI

    Time frame: End of study compared to baseline

  2. Affected body surface area

    Time frame: End of study compared to baseline

  3. Patient's assessment of itch, quality of sleep, and global assessment

    Time frame: End of study compared to baseline

  4. Children's Dermatological Life Quality Index

    Time frame: End of study compared to baseline

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 6, 2007
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.