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

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ClinicalTrials.gov Identifier: NCT00667160
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 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 Mild Atopic Dermatitis
Study Start Date : December 2002
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in 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 ]


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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:

  • 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

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): 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.

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00667160     History of Changes
Other Study ID Numbers: 20-02-006
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc:
Mild 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