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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pimecrolimus

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, T-cell, pimecrolimus, children, facial, Facial atopic dermatitis

Eligibility Criteria

2 Years - 11 Years (Child)All Sexes

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

Sites / Locations

This study is not being conducted in the United States

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Pimecrolimus

Pimecrolimus vehicle cream

Outcomes

Primary Outcome Measures

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

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)

Full Information

NCT ID

NCT00130364

First Posted

August 12, 2005

Last Updated

January 10, 2008

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00130364

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic dermatitis, T-cell, pimecrolimus, children, facial, Facial atopic dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Pimecrolimus

Arm Title

Arm Type

Placebo Comparator

Arm Description

Pimecrolimus vehicle cream

Intervention Type

Drug

Intervention Name(s)

Pimecrolimus

Other Intervention Name(s)

Elidel

Intervention Description

Pimecrolimus 1 % cream

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pimecrolimus vehicle cream (placebo)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

This study is not being conducted in the United States

City

Novartis Pharmaceuticals

State/Province

New Jersey

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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