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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00351052

Enrollment

184

Registered

2006-07-12

Start date

2001-12-31

Completion date

2004-09-30

Last updated

2008-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric

Brief summary

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

Interventions

DRUGPimecrolimus

Pimecroliums cream 1 % bid.

DRUGPlacebo

Vehicle control (placebo) bid.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Corticoid-sparing effect of pimecrolimus cream 1%	—

Secondary

Measure	Time frame
atopic dermatitis control	—
safety of pimecrolimus cream 1%	—
quality of life	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026