Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dermatitis, Atopic
Intervention: Pimecrolimus plus topical corticosteroid (TCS) (Drug); Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis
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.
Clinical Details
Official title: Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Secondary outcome: Incidence of all other adverse eventsTime 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
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Severe atopic dermatitis
- 5% of total body surface area (TBSA) affected
Exclusion Criteria:
- Concurrent skin diseases (infections)
- Immunocompromised
- Recently received phototherapy or systemic therapy
Locations and Contacts
Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States
Children's Hospital -San Diego, San Diego, California 92123, United States
National Jewish Medical and Research Center, Denver, Colorado 80206, United States
Dermatology Associates and Research, Coral Gables, Florida 33134, United States
Medical College of Georgia - Clinical Investigative Services, Augusta, Georgia 30912, United States
Dartmouth Hitchcock Medical Center Section of Dermatology, Lebanon, New Hampshire 03756, United States
Wake Forest University School of Medicine Dept. of Dermatology, Winston-Salem, North Carolina 27157, United States
Calcagno Research and Development, Gresham, Oregon 97030, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
520 Trinity Creek Cove, Cordova, Tennessee 38018, United States
Virginia Commonwealth University, Richmond, Virginia 23298, United States
A.S.T.H.M.A., Inc, Seattle, Washington 98105, United States
Additional Information
Starting date: May 2005
Ending date: January 2007
Last updated: January 10, 2008
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