NCT00351052

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

First QC Date

July 10, 2006

Last Update Submit

January 15, 2008

Conditions

Atopic Dermatitis

Keywords

Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric

Outcome Measures

Primary Outcomes (1)

  • Corticoid-sparing effect of pimecrolimus cream 1%

Secondary Outcomes (3)

  • atopic dermatitis control

  • safety of pimecrolimus cream 1%

  • quality of life

Study Arms (2)

1

EXPERIMENTAL

Pimecrolimus

Drug: Pimecrolimus

2

PLACEBO COMPARATOR

Vehicle

Drug: Placebo

Interventions

PimecrolimusDRUG

Pimecroliums cream 1 % bid.

Also known as: Elidel
1
PlaceboDRUG

Vehicle control (placebo) bid.

2

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Investigational Site, Germany

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Novartis AG

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 10, 2006

First Posted

July 12, 2006

Study Start

December 1, 2001

Study Completion

September 1, 2004

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

DE(1)