Clinical trial NCT00667160: Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis
Official title: A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Mild Atopic Dermatitis
Protopic
Pediatric
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 426
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Eczema Area and Severity Index (EASI)
timeFrame: 6 Weeks
Secondary outcomes:
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA)
timeFrame: 6 Weeks
measure: Patient's evaluation of itch
timeFrame: 6 Weeks
measure: Body surface area affected
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Clinton township
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Durham
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma US, Inc.
name: use central contact
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.jaad.2004.12.038.
citation: 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.