Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
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
1 other identifier
interventional
1,091
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2003
Longer than P75 for phase_4
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
March 23, 2011
CompletedMarch 23, 2011
February 1, 2011
4.3 years
July 26, 2005
December 8, 2010
February 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
36 months
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.
6 years
Secondary Outcomes (5)
Long Term Safety in Infants and Young Children
6 years
Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
6 years (36 month Double-Blind Phase)
Corticosteroid and Pimecrolimus Drug Use
48 months
Atopic Dermatitis (AD) Remission Time
36 month Double-Blind Phase
Patient/Caregiver Quality of Life
From Baseline to Visit 5 , 6, 8, 10, 12, and 14
Study Arms (2)
1
EXPERIMENTALPimecrolimus
2
ACTIVE COMPARATORCorticosteroid
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of atopic dermatitis
- Family history of atopy
- 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
You may not qualify if:
- Diagnosis of or substantial clinical evidence for food or other allergies at baseline
- Other protocol related criteria may apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Alabama Allergy and Asthma Center
Birmingham, Alabama, 35209, United States
Northwest Arkansas Pediatric Clinic, P.A.
Fayetteville, Arkansas, 72703, United States
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, 72401, United States
Southern California Research
Mission Viejo, California, 92691, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Stanford Dermatology Clinic and Clinical Trials Dept
Redwood City, California, 94063, United States
Capital Allergy Respiratory Disease Center
Sacramento, California, 95819, United States
Children's Hospital San Diego
San Diego, California, 92123, United States
Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division
Walnut Creek, California, 94598, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Dermatology Associates and Research
Coral Gables, Florida, 33134, United States
Emerald Coast Clinical Research
Pensacola, Florida, 32503, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, 46202, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
Dermatology Specialists
Louisville, Kentucky, 40202, United States
Rx R & D
Metarie, Louisiana, 70002, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Children's Hospital - Boston
Boston, Massachusetts, 02115, United States
Dermatology, PLLC
Ann Arbor, Michigan, 48103, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Central Dermatology
St Louis, Missouri, 63117, United States
Skin Specialists, P.C.
Omaha, Nebraska, 68144, United States
Dartmouth-Hitchcock Medical Center/Dermatology Section
Lebanon, New Hampshire, 03756, United States
Children's Medical Group
Hopewell Junction, New York, 12533, United States
Dermatology Associates of St. Luke's - Roosevelt
New York, New York, 10025, United States
Calcagno Research and Development
Gresham, Oregon, 97030, United States
Oregon Health Science University - Dermatology Dept.
Portland, Oregon, 97201, United States
The Childrens' Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Texas Children's Hospital, BCM
Houston, Texas, 77030, United States
Alpine Medical Group, LLC
Salt Lake City, Utah, 84102, United States
Granger Medical Clinic
West Valley City, Utah, 84120, United States
Virginia Clinical Research
Norfolk, Virginia, 23507, United States
Asthma Inc
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 26598458DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
July 26, 2005
First Posted
July 28, 2005
Study Start
October 1, 2003
Primary Completion
January 1, 2008
Study Completion
November 1, 2008
Last Updated
March 23, 2011
Results First Posted
March 23, 2011
Record last verified: 2011-02