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Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pimecrolimus
Corticosteroid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic, dermatitis, asthma, children, modification, Atopic dermatitis/atopy

Eligibility Criteria

3 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of atopic dermatitis Family history of atopy 3 to 18 months of age at baseline At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2) Clinical evidence of atopic dermatitis for no longer than 3 months Exclusion Criteria: Diagnosis of or substantial clinical evidence for food or other allergies at baseline Other protocol related criteria may apply

Sites / Locations

  • Alabama Allergy and Asthma Center
  • Northwest Arkansas Pediatric Clinic, P.A.
  • The Children's Clinic of Jonesboro
  • Southern California Research
  • Children's Hospital of Orange County
  • Stanford Dermatology Clinic and Clinical Trials Dept
  • Capital Allergy Respiratory Disease Center
  • Children's Hospital San Diego
  • Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division
  • National Jewish Medical and Research Center
  • Dermatology Associates and Research
  • Emerald Coast Clinical Research
  • Children's Memorial Hospital
  • Indiana University Outpatient Clinical Research
  • Central Kentucky Research Associates
  • Dermatology Specialists
  • Rx R & D
  • Johns Hopkins Hospital
  • Children's Hospital - Boston
  • Dermatology, PLLC
  • Mayo Clinic Rochester
  • Central Dermatology
  • Skin Specialists, P.C.
  • Dartmouth-Hitchcock Medical Center/Dermatology Section
  • Children's Medical Group
  • Dermatology Associates of St. Luke's - Roosevelt
  • Calcagno Research and Development
  • Oregon Health Science University - Dermatology Dept.
  • The Childrens' Hospital of Philadelphia
  • Allegheny General Hospital
  • Tennessee Clinical Research Center
  • Texas Children's Hospital, BCM
  • Alpine Medical Group, LLC
  • Granger Medical Clinic
  • Virginia Clinical Research
  • Asthma Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Pimecrolimus

Corticosteroid

Outcomes

Primary Outcome Measures

Atopic Dermatitis (AD) Disease Control Over 36 Months
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
Note: The results for this efficacy variable are not reported due to early termination of the study.

Secondary Outcome Measures

Long Term Safety in Infants and Young Children
Note: The results of this secondary outcome is not reported due to early termination of the study.
Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study. Note: The results at six years are not reported due to early termination of the study.
Corticosteroid and Pimecrolimus Drug Use
Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase. Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.
Atopic Dermatitis (AD) Remission Time
Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".
Patient/Caregiver Quality of Life
Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.

Full Information

First Posted
July 26, 2005
Last Updated
February 25, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00124709
Brief Title
Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
Official Title
An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic, dermatitis, asthma, children, modification, Atopic dermatitis/atopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1091 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus
Arm Title
2
Arm Type
Active Comparator
Arm Description
Corticosteroid
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
conventional corticosteroid-based treatment
Primary Outcome Measure Information:
Title
Atopic Dermatitis (AD) Disease Control Over 36 Months
Description
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Time Frame
36 months
Title
Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
Description
Note: The results for this efficacy variable are not reported due to early termination of the study.
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Long Term Safety in Infants and Young Children
Description
Note: The results of this secondary outcome is not reported due to early termination of the study.
Time Frame
6 years
Title
Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
Description
Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study. Note: The results at six years are not reported due to early termination of the study.
Time Frame
6 years (36 month Double-Blind Phase)
Title
Corticosteroid and Pimecrolimus Drug Use
Description
Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase. Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.
Time Frame
48 months
Title
Atopic Dermatitis (AD) Remission Time
Description
Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".
Time Frame
36 month Double-Blind Phase
Title
Patient/Caregiver Quality of Life
Description
Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.
Time Frame
From Baseline to Visit 5 , 6, 8, 10, 12, and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of atopic dermatitis Family history of atopy 3 to 18 months of age at baseline At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2) Clinical evidence of atopic dermatitis for no longer than 3 months Exclusion Criteria: Diagnosis of or substantial clinical evidence for food or other allergies at baseline Other protocol related criteria may apply
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
Alabama Allergy and Asthma Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Northwest Arkansas Pediatric Clinic, P.A.
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
The Children's Clinic of Jonesboro
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Dermatology Clinic and Clinical Trials Dept
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Capital Allergy Respiratory Disease Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
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
Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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
Emerald Coast Clinical Research
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Indiana University Outpatient Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Central Kentucky Research Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Rx R & D
City
Metarie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Children's Hospital - Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dermatology, PLLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Central Dermatology
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Skin Specialists, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center/Dermatology Section
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Children's Medical Group
City
Hopewell Junction
State/Province
New York
ZIP/Postal Code
12533
Country
United States
Facility Name
Dermatology Associates of St. Luke's - Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Calcagno Research and Development
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Oregon Health Science University - Dermatology Dept.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
The Childrens' Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Texas Children's Hospital, BCM
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alpine Medical Group, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Granger Medical Clinic
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Asthma Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26598458
Citation
Spergel JM, Boguniewicz M, Schneider L, Hanifin JM, Paller AS, Eichenfield LF. Food Allergy in Infants With Atopic Dermatitis: Limitations of Food-Specific IgE Measurements. Pediatrics. 2015 Dec;136(6):e1530-8. doi: 10.1542/peds.2015-1444.
Results Reference
derived

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Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

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