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 IV

MedlinePlus related topics:

Eczema

ChemIDplus related topics:

Corticosteroids Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

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
1: Experimental Pimecrolimus 1 % cream plus topical corticosteroid (TCS)	Drug: Pimecrolimus plus topical corticosteroid (TCS) Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
2: Placebo Comparator 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

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

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981C2439
First Received:	July 14, 2005
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00121381
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

Study placed in the following topic categories:

Hypersensitivity

Dermatitis, Atopic

Genetic Diseases, Inborn

Skin Diseases

Hypersensitivity, Immediate

Skin Diseases, Eczematous

Pimecrolimus

Tacrolimus

Skin Diseases, Genetic

Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00121381