A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis

This study has been completed.

First Received on April 23, 2008. Last Updated on July 9, 2008 History of Changes

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00666302

Purpose

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

Condition	Intervention	Phase
Dermatitis, Atopic	Drug: tacrolimus ointment Drug: pimecrolimus cream	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis

Resource links provided by NLM:

Drug Information available for: Tacrolimus anhydrous Tacrolimus Pimecrolimus

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change in Eczema Area and Severity Index (EASI) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator's Global Atopic Dermatitis Assessment (IGADA) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Patient's evaluation of itch [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Body surface area affected [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment:	413
Study Start Date:	October 2002
Study Completion Date:	November 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: tacrolimus ointment topical Other Names: Protopic FK506 ointment
Active Comparator: 2	Drug: pimecrolimus cream topical Other Name: Elidel

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
Negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

Skin disorder other than Atopic Dermatitis in the areas to be treated
Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
Clinically infected Atopic Dermatitis at baseline
Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
Known hypersensitivity to macrolides or any excipient of either study medication
Chronic condition which is either not stable or not well controlled
Pregnant or breast feeding an infant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666302

Locations

United States, Alabama

Birmingham, Alabama, United States, 35205
United States, California

San Francisco, California, United States, 94118
United States, Kansas

Kansas City, Kansas, United States, 66160
United States, Michigan

Ann Arbor, Michigan, United States, 48109
United States, Missouri

St Louis, Missouri, United States, 63110
United States, New York

New York, New York, United States, 10029
United States, North Carolina

Winston-Salem, North Carolina, United States, 27157
United States, Ohio

Cincinnati, Ohio, United States, 45219
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19107
United States, Texas

Dallas, Texas, United States, 75230

San Antonio, Texas, United States, 78229
United States, Utah

Salt Lake City, Utah, United States, 84124
United States, Virginia

Norfolk, Virginia, United States, 23507
Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 1Z4

Halifax, Nova Scotia, Canada, B3H 1V7

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use central contact

Astellas Pharma US, Inc.

More Information

No publications provided

Responsible Party:	Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier:	NCT00666302 History of Changes
Other Study ID Numbers:	20-02-004
Study First Received:	April 23, 2008
Last Updated:	July 9, 2008
Health Authority:	United States: Institutional Review Board; Canada: Canadian Institutes of Health Research

Keywords provided by Astellas Pharma Inc:

Atopic Dermatitis
Protopic
Elidel

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Pimecrolimus
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 13, 2012