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Dermatitis |
Types of dermatitis; Contact Dermatitis; Dermatitis-Atopic Eczema; Dermatitis/Eczema; Rash; Skin Disorders, Dermatitis; Skin Rash; Slide Show: Types of Dermatitis |
Clinical Trial: Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) with Severe Atopic Dermatitis
This study is currently recruiting patients.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Dermatitis, Atopic | Drug: Pimecrolimus cream 1% | Phase IV |
MedlinePlus related topics: Allergy; Dermatitis; Genetic Disorders; Skin Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Further Study Details:
Study start: May 2005
Eligibility
Ages Eligible for Study: 2 Years - 17 Years, Genders Eligible for Study: 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00121381
Novartis Pharmaceuticals 862-778-8300
California
Pediatric Care Medical Group, Inc., Huntington Beach, California, 92647, United States; Recruiting
jenny Alexander 714-842-1441
Paul Qaqundah, Principal Investigator
Paul Qaqundah, Principal Investigator
Children''''s Hospital -San Diego, San Diego, California, 92123, United States; Recruiting
Nicola Borok 858-576-1700 Ext. 4295
Lawrence Eichenfield, Principal Investigator
Lawrence Eichenfield, Principal Investigator
Colorado
National Jewish Medical and Research Center, Denver, Colorado, 80206, United States; Recruiting
Susan Leung 303-398-1549
Mark Boguniewicz, Principal Investigator
Mark Boguniewicz, Principal Investigator
Florida
Dermatology Associates and Research, Coral Gables, Florida, 33134, United States; Recruiting
Isabel Oropesa 305-567-1930
David Rodriguez, Principal Investigator
David Rodriguez, Principal Investigator
Georgia
Medical College of Georgia - Clinical Investigative Services, Augusta, Georgia, 30912, United States; Recruiting
Amy Claus 706-721-4125
Cheryl Barnes, Principal Investigator
Cheryl Barnes, Principal Investigator
New Hampshire
Dartmouth Hitchcock Medical Center Section of Dermatology, Lebanon, New Hampshire, 03756, United States; Recruiting
laura Barrett 603-653-9418
James Dinulos, Principal Investigator
James Dinulos, Principal Investigator
North Carolina
Wake Forest University School of Medicine Dept. of Dermatology, Winston Salem, North Carolina, 27157, United States; Recruiting
Kathy Johnson 336-716-3775
Alan Fleischer, Principal Investigator
Alan Fleischer, Principal Investigator
Oregon
Calcagno Research and Development, Gresham, Oregon, 97030, United States; Recruiting
Susan Stindt 503-491-0714
John Calcagno, Principal Investigator
John Calcagno, Principal Investigator
Pennsylvania
Children''''s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Kathy Pinzone 215-590-9959
Jonathan Spergel, Principal Investigator
Jonathan Spergel, Principal Investigator
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
Elaine St Pierre 401-444-7583
jennie Muglia, Principal Investigator
jennie Muglia, Principal Investigator
Tennessee
520 Trinity Creek Cove, Cordova, Tennessee, 38018, United States; Recruiting
Elaine Rackley 901-755-2511
Thomas Chu, Principal Investigator
Thomas Chu, Principal Investigator
Virginia
Virginia Commonwealth University, Richmond, Virginia, 23298, United States; Recruiting
Tammy Anderson 804-827-1856
Anne Marie Irani, Principal Investigator
Anne Marie Irani, Principal Investigator
Washington
A.S.T.H.M.A., Inc, Seattle, Washington, 98105, United States; Recruiting
grace White 206-525-5520
Ashley Tatum, Principal Investigator
Ashley Tatum, Principal Investigator
Study chairs or principal investigators
Novartis Pharmaceuticals, Study Chair, Novartis
More Information
Study ID Numbers: ASM981C2439
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 20, 2005
ClinicalTrials.gov Identifier: NCT00121381
Health Authority: United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medicinal Devices; Italy: Ministry of Health; South Africa: Medicines Control Council
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 20, 2005
ClinicalTrials.gov Identifier: NCT00121381
Health Authority: United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medicinal Devices; Italy: Ministry of Health; South Africa: Medicines Control Council
ClinicalTrials.gov processed this record on 2005-07-26
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