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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00666302
First received: April 23, 2008
Last updated: July 9, 2008
Last verified: July 2008
  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 4

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:


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
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: 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 July 24, 2014