NCT00150059

Brief Summary

To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients \> 3 months of age with mild to moderate atopic dermatitis) This study is not enrolling patients in the United States.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

First QC Date

September 7, 2005

Last Update Submit

February 14, 2008

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, eczema, mild to moderate, children, IGA

Outcome Measures

Primary Outcomes (3)

  • Investigator Global Assessment (IGA) score for the whole body and for the face only.

  • Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation.

  • Safety assessed by adverse events.

Interventions

Pimecrolimus Cream 1%DRUG
Also known as: Elidel

Eligibility Criteria

Age3 Months+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

This study is not being conducted in the United States

Investigative Site, Philippines

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 Healthcare Philippines

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

December 1, 2004

Study Completion

December 1, 2005

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

PH(1)