Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT00121381
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Severe atopic dermatitis
- 5% of total body surface area (TBSA) affected
- Concurrent skin diseases (infections)
- Immunocompromised
- Recently received phototherapy or systemic therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pimecrolimus plus topical corticosteroid (TCS) Pimecrolimus 1 % cream plus topical corticosteroid (TCS) 2 Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
- Primary Outcome Measures
Name Time Method Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (13)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Calcagno Research and Development
🇺🇸Gresham, Oregon, United States
Pediatric Care Medical Group, Inc.
🇺🇸Huntington Beach, California, United States
Children's Hospital -San Diego
🇺🇸San Diego, California, United States
Medical College of Georgia - Clinical Investigative Services
🇺🇸Augusta, Georgia, United States
Wake Forest University School of Medicine Dept. of Dermatology
🇺🇸Winston-Salem, North Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
A.S.T.H.M.A., Inc
🇺🇸Seattle, Washington, United States
Dermatology Associates and Research
🇺🇸Coral Gables, Florida, United States
Dartmouth Hitchcock Medical Center Section of Dermatology
🇺🇸Lebanon, New Hampshire, United States
520 Trinity Creek Cove
🇺🇸Cordova, Tennessee, United States
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States