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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: April 23, 2008
Last updated: September 17, 2014
Last verified: September 2014
Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric 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 Pediatric Patients With Moderate to Severe Atopic Dermatitis

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change 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: 226
Study Start Date: December 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tacrolimus ointment
Other Names:
  • Protopic
  • FK506 ointment
Active Comparator: 2 Drug: pimecrolimus cream
Other Name: Elidel

Detailed Description:
This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's 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
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Please refer to this study by its identifier: NCT00666159

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, 48038
United States, Nebraska
Omaha, Nebraska, United States, 68144
United States, Nevada
Reno, Nevada, United States, 89511
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Wilmington, North Carolina, United States, 28401
Winston Salem, North Carolina, United States, 27157
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use central contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00666159     History of Changes
Other Study ID Numbers: 20-02-005 
Study First Received: April 23, 2008
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on April 27, 2016