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

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ClinicalTrials.gov Identifier: NCT00666159
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: tacrolimus ointment Drug: pimecrolimus cream Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2002
Primary Completion Date : May 2003
Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus ointment
topical
Other Names:
  • Protopic
  • FK506 ointment
Active Comparator: 2 Drug: pimecrolimus cream
topical
Other Name: Elidel


Outcome Measures

Primary Outcome Measures :
  1. Change Eczema Area and Severity Index (EASI) [ Time Frame: 6 Weeks ]

Secondary Outcome Measures :
  1. Investigator's Global Atopic Dermatitis Assessment (IGADA) [ Time Frame: 6 Weeks ]
  2. Patient's evaluation of itch [ Time Frame: 6 Weeks ]
  3. Body surface area affected [ Time Frame: 6 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666159


Locations
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
Investigators
Study Director: Use central contact Astellas Pharma US, Inc.
More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00666159     History of Changes
Other Study ID Numbers: 20-02-005
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc:
Atopic Dermatitis
Protopic
Pediatric

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
Tacrolimus
Pimecrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents