Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
- Registration Number
- NCT00124709
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1091
- 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
- Diagnosis of or substantial clinical evidence for food or other allergies at baseline
Other protocol related criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Corticosteroid Corticosteroid 1 Pimecrolimus Pimecrolimus
- Primary Outcome Measures
Name Time Method Atopic Dermatitis (AD) Disease Control Over 36 Months 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 6 years Note: The results for this efficacy variable are not reported due to early termination of the study.
- Secondary Outcome Measures
Name Time Method Long Term Safety in Infants and Young Children 6 years 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 6 years (36 month Double-Blind Phase) 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 48 months 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 36 month Double-Blind Phase 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 From Baseline to Visit 5 , 6, 8, 10, 12, and 14 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.
Trial Locations
- Locations (36)
Children's Medical Group
🇺🇸Hopewell Junction, New York, United States
Central Dermatology
🇺🇸St Louis, Missouri, United States
Rx R & D
🇺🇸Metarie, Louisiana, United States
Dartmouth-Hitchcock Medical Center/Dermatology Section
🇺🇸Lebanon, New Hampshire, United States
Northwest Arkansas Pediatric Clinic, P.A.
🇺🇸Fayetteville, Arkansas, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Capital Allergy Respiratory Disease Center
🇺🇸Sacramento, California, United States
Dermatology Specialists
🇺🇸Louisville, Kentucky, United States
Emerald Coast Clinical Research
🇺🇸Pensacola, Florida, United States
Calcagno Research and Development
🇺🇸Gresham, Oregon, United States
Dermatology Associates of St. Luke's - Roosevelt
🇺🇸New York, New York, United States
Stanford Dermatology Clinic and Clinical Trials Dept
🇺🇸Redwood City, California, United States
The Childrens' Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Children's Hospital San Diego
🇺🇸San Diego, California, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Indiana University Outpatient Clinical Research
🇺🇸Indianapolis, Indiana, United States
Children's Hospital - Boston
🇺🇸Boston, Massachusetts, United States
Asthma Inc
🇺🇸Seattle, Washington, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Alpine Medical Group, LLC
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Alabama Allergy and Asthma Center
🇺🇸Birmingham, Alabama, United States
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
Oregon Health Science University - Dermatology Dept.
🇺🇸Portland, Oregon, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Skin Specialists, P.C.
🇺🇸Omaha, Nebraska, United States
The Children's Clinic of Jonesboro
🇺🇸Jonesboro, Arkansas, United States
Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division
🇺🇸Walnut Creek, California, United States
Central Kentucky Research Associates
🇺🇸Lexington, Kentucky, United States
Texas Children's Hospital, BCM
🇺🇸Houston, Texas, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Clinical Research
🇺🇸Norfolk, Virginia, United States
Granger Medical Clinic
🇺🇸West Valley City, Utah, United States
Dermatology Associates and Research
🇺🇸Coral Gables, Florida, United States
Dermatology, PLLC
🇺🇸Ann Arbor, Michigan, United States