Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis - Full Text View

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 plus topical corticosteroid (TCS) Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Steroids

Drug Information available for: Pimecrolimus

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)

Secondary Outcome Measures:

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


Estimated Enrollment:	400
Study Start Date:	May 2005
Study Completion Date:	January 2007

Arms	Assigned Interventions
Experimental: 1 Pimecrolimus 1 % cream plus topical corticosteroid (TCS)	Drug: Pimecrolimus plus topical corticosteroid (TCS) Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily Other Name: Elidel
Placebo Comparator: 2 Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)	Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) twice daily administration

Eligibility


Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121381

Locations


United States, California
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
Children's Hospital -San Diego
San Diego, California, United States, 92123
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
Dermatology Associates and Research
Coral Gables, Florida, United States, 33134
United States, Georgia
Medical College of Georgia - Clinical Investigative Services
Augusta, Georgia, United States, 30912
United States, New Hampshire
Dartmouth Hitchcock Medical Center Section of Dermatology
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Wake Forest University School of Medicine Dept. of Dermatology
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Calcagno Research and Development
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
520 Trinity Creek Cove
Cordova, Tennessee, United States, 38018
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
A.S.T.H.M.A., Inc
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

No publications provided


Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00121381 History of Changes
Other Study ID Numbers:	CASM981C2439
Study First Received:	July 14, 2005
Last Updated:	January 10, 2008
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health South Africa: Medicines Control Council

Keywords provided by Novartis:


Atopic dermatitis T-cell pimecrolimus children topical corticosteroids

Additional relevant MeSH terms:


Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Pimecrolimus Tacrolimus Analgesics Analgesics, Non-Narcotic	Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Central Nervous System Agents Dermatologic Agents Immunologic Factors Immunosuppressive Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015