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

NCT ID: NCT00351052

Last Updated: 2008-01-17

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

PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-09-30

Brief Summary

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

Detailed Description

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Conditions

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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

Pimecrolimus

Group Type EXPERIMENTAL

Pimecrolimus

Intervention Type DRUG

Pimecroliums cream 1 % bid.

2

Vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle control (placebo) bid.

Interventions

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Pimecrolimus

Pimecroliums cream 1 % bid.

Intervention Type DRUG

Placebo

Vehicle control (placebo) bid.

Intervention Type DRUG

Other Intervention Names

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Elidel

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis AG

Role: STUDY_CHAIR

Novartis

Locations

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Investigational Site, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CASM981CDE10

Identifier Type: -

Identifier Source: org_study_id

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