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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dermatitis, Atopic

Intervention: tacrolimus ointment (Drug); pimecrolimus cream (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
use central contact, Study Director, Affiliation: Astellas Pharma US, Inc.

Summary

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

Clinical Details

Official title: A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change in Eczema Area and Severity Index (EASI)

Secondary outcome:

Investigator's Global Atopic Dermatitis Assessment (IGADA)

Patient's evaluation of itch

Body surface area affected

Eligibility

Minimum age: 2 Years. Maximum age: 16 Years. Gender(s): Both.

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

Locations and Contacts

San Diego, California 92123, United States

New Haven, Connecticut 06519, United States

Miami, Florida 33136, United States

Miami, Florida 33155, United States

Chicago, Illinois 60614, United States

Boston, Massachusetts 02115, United States

Clinton township, Michigan 48308, United States

Fridley, Minnesota 55432, United States

Omaha, Nebraska 68144, United States

Reno, Nevada 89511, United States

Durham, North Carolina 27705, United States

Wilmington, North Carolina 28401, United States

Winston Salem, North Carolina 27157, United States

Cleveland, Ohio 44106, United States

Portland, Oregon 97201, United States

Pittsburgh, Pennsylvania 15218, United States

Dallas, Texas 75390, United States

Galveston, Texas 77555, United States

Houston, Texas 62016, United States

Additional Information

Link to Results on JAPIC - enter 140579 in the JapicCTI-RNo. field

Related publications:

Paller AS, Lebwohl M, Fleischer AB Jr, Antaya R, Langley RG, Kirsner RS, Blum RR, Rico MJ, Jaracz E, Crowe A, Linowski GJ; US/Canada Tacrolimus Ointment Study Group. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol. 2005 May;52(5):810-22.

Kirsner RS, Heffernan MP, Antaya R. Safety and efficacy of tacrolimus ointment versus pimecrolimus cream in the treatment of patients with atopic dermatitis previously treated with corticosteroids. Acta Derm Venereol. 2010;90(1):58-64. doi: 10.2340/00015555-0748.

Starting date: December 2002
Last updated: September 17, 2014

Page last updated: August 23, 2015

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