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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Dermatitis, Atopic	Drug: Pimecrolimus plus topical corticosteroid (TCS); Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Study Start Date :	May 2005
Actual Study Completion Date :	January 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Incidence of all other adverse events
2. Time to relapse of atopic dermatitis
3. Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
4. Efficacy measured by IGA (treatment success and improvement)
5. Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 17 Years (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00121381 History of Changes
Other Study ID Numbers:	CASM981C2439
First Posted:	July 21, 2005
Last Update Posted:	January 15, 2008
Last Verified:	January 2008

Keywords provided by Novartis:

Atopic dermatitis; T-cell; pimecrolimus; children; topical corticosteroids

Additional relevant MeSH terms:

Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pimecrolimus; Tacrolimus; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action