NCT00130364

Brief Summary

This study is not being conducted in the United States of America (USA). Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

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

August 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

First QC Date

August 12, 2005

Last Update Submit

January 10, 2008

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisT-cellpimecrolimuschildrenfacialFacial atopic dermatitis

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)

Secondary Outcomes (4)

  • Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score

  • The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score

  • The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)

  • Time to clearance of facial IGA (score of 0 or 1)

Study Arms (2)

1

EXPERIMENTAL

Pimecrolimus

Drug: Pimecrolimus

2

PLACEBO COMPARATOR

Pimecrolimus vehicle cream

Drug: Placebo

Interventions

PimecrolimusDRUG

Pimecrolimus 1 % cream

Also known as: Elidel
1
PlaceboDRUG

Pimecrolimus vehicle cream (placebo)

2

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Mild to moderate facial atopic dermatitis
  • Patients intolerant of, or dependent on, topical corticosteroids

You may not qualify if:

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

This study is not being conducted in the United States

Novartis Pharmaceuticals, New Jersey, United States

Location

MeSH Terms

Conditions

Dermatitis, AtopicFacies

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 DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

August 1, 2005

Study Completion

August 1, 2006

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(1)