Clinical trial NCT00124709: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic, dermatitis, asthma, children, modification
Atopic dermatitis/atopy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 1091
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Atopic Dermatitis (AD) Disease Control Over 36 Months
timeFrame: 36 months
measure: Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
timeFrame: 6 years
Secondary outcomes:
measure: Long Term Safety in Infants and Young Children
timeFrame: 6 years
measure: Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies
timeFrame: 6 years (36 month Double-Blind Phase)
measure: Corticosteroid and Pimecrolimus Drug Use
timeFrame: 48 months
measure: Atopic Dermatitis (AD) Remission Time
timeFrame: 36 month Double-Blind Phase
measure: Patient/Caregiver Quality of Life
timeFrame: From Baseline to Visit 5 , 6, 8, 10, 12, and 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy and Asthma Center
state: Alabama
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic, P.A.
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro
state: Arkansas
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Redwood City
country: United States
facility: Stanford Dermatology Clinic and Clinical Trials Dept
state: California
city: Sacramento
country: United States
facility: Capital Allergy Respiratory Disease Center
state: California
city: San Diego
country: United States
facility: Children's Hospital San Diego
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division
state: California
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Clinical Research
state: Florida
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Outpatient Clinical Research
state: Indiana
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Metarie
country: United States
facility: Rx R & D
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Children's Hospital - Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: Dermatology, PLLC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: St Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center/Dermatology Section
state: New Hampshire
city: Hopewell Junction
country: United States
facility: Children's Medical Group
state: New York
city: New York
country: United States
facility: Dermatology Associates of St. Luke's - Roosevelt
state: New York
city: Gresham
country: United States
facility: Calcagno Research and Development
state: Oregon
city: Portland
country: United States
facility: Oregon Health Science University - Dermatology Dept.
state: Oregon
city: Philadelphia
country: United States
facility: The Childrens' Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital, BCM
state: Texas
city: Salt Lake City
country: United States
facility: Alpine Medical Group, LLC
state: Utah
city: West Valley City
country: United States
facility: Granger Medical Clinic
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Asthma Inc
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
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.