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Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic dermatitis, T-cell, pimecrolimus, children, topical corticosteroids

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Severe atopic dermatitis 5% of total body surface area (TBSA) affected Exclusion Criteria: Concurrent skin diseases (infections) Immunocompromised Recently received phototherapy or systemic therapy

Sites / Locations

  • Pediatric Care Medical Group, Inc.
  • Children's Hospital -San Diego
  • National Jewish Medical and Research Center
  • Dermatology Associates and Research
  • Medical College of Georgia - Clinical Investigative Services
  • Dartmouth Hitchcock Medical Center Section of Dermatology
  • Wake Forest University School of Medicine Dept. of Dermatology
  • Calcagno Research and Development
  • Children's Hospital of Philadelphia
  • Rhode Island Hospital
  • 520 Trinity Creek Cove
  • Virginia Commonwealth University
  • A.S.T.H.M.A., Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Pimecrolimus 1 % cream plus topical corticosteroid (TCS)

Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Outcomes

Primary Outcome Measures

Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)

Secondary Outcome Measures

Incidence of all other adverse events
Time to relapse of atopic dermatitis
Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
Efficacy measured by IGA (treatment success and improvement)
Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent

Full Information

First Posted
July 14, 2005
Last Updated
January 10, 2008
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00121381
Brief Title
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Official Title
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Atopic dermatitis, T-cell, pimecrolimus, children, topical corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus plus topical corticosteroid (TCS)
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Intervention Description
twice daily administration
Primary Outcome Measure Information:
Title
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Secondary Outcome Measure Information:
Title
Incidence of all other adverse events
Title
Time to relapse of atopic dermatitis
Title
Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
Title
Efficacy measured by IGA (treatment success and improvement)
Title
Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe atopic dermatitis 5% of total body surface area (TBSA) affected Exclusion Criteria: Concurrent skin diseases (infections) Immunocompromised Recently received phototherapy or systemic therapy
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
Pediatric Care Medical Group, Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Children's Hospital -San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Dermatology Associates and Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Medical College of Georgia - Clinical Investigative Services
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center Section of Dermatology
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Wake Forest University School of Medicine Dept. of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Calcagno Research and Development
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
520 Trinity Creek Cove
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
A.S.T.H.M.A., Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

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