Skip to main content
OpenTrials
Completed

NCT Number: NCT00351052

Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema 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–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Germany

Who can participate

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

Inclusion criteria

  • Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
  • responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase

Exclusion criteria

  • Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study

Treatment and study plan

pimecrolimus

Drug

Pimecroliums cream 1 % bid.

Other names: Elidel

Placebo

Drug

Vehicle control (placebo) bid.

Primary outcomes

  1. Corticoid-sparing effect of pimecrolimus cream 1%

Secondary outcomes

  1. atopic dermatitis control

  2. safety of pimecrolimus cream 1%

  3. quality of life

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis

Important dates

Study start
2001
Study completion
2004
First posted
Jul 12, 2006
Registry last updated
Jan 17, 2008

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.