Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

January 10, 2008 updated by: Novartis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Novartis Pharmaceuticals, New Jersey, United States
        • This study is not being conducted in the United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus 1 % cream
Other Names:
  • Elidel
Placebo Comparator: 2
Pimecrolimus vehicle cream
Drug: Placebo
Pimecrolimus vehicle cream (placebo)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 12, 2005

First Submitted That Met QC Criteria

August 12, 2005

First Posted (Estimate)

August 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981C2440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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