Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00667160
First received: April 23, 2008
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients


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 Pediatric Patients With Mild 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: 426
Study Start Date: December 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:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area
  • If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

  • Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
  • Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
  • Patient has clinically infected Atopic Dermatitis at baseline
  • Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
  • Patient has a known hypersensitivity to macrolides or any excipient of either study medication
  • Patient has a chronic condition which is either not stable or not well controlled
  • Patient is 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: NCT00667160

Locations
United States, California
San Diego, California, United States, 92123
United States, Connecticut
New Haven, Connecticut, United States, 06519
United States, Florida
Miami, Florida, United States, 33136
Miami, Florida, United States, 33155
United States, Illinois
Chicago, Illinois, United States, 60614
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Clinton township, Michigan, United States, 48308
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, Nebraska
Omaha, Nebraska, United States, 68144
United States, Nevada
Reno, Nevada, United States, 89511
United States, North Carolina
Durham, North Carolina, United States, 27705
Wilmington, North Carolina, United States, 28401
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Oregon
Portland, Oregon, United States, 97201
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15218
United States, Texas
Dallas, Texas, United States, 75390
Galveston, Texas, United States, 77555
Houston, Texas, United States, 62016
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: use central contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00667160     History of Changes
Other Study ID Numbers: 20-02-006
Study First Received: April 23, 2008
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Mild Atopic Dermatitis
Protopic
Pediatric

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 September 18, 2014