Clinical trial NCT00666302: A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
Official title: A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis
Protopic
Elidel
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 413
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
* Negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

* Skin disorder other than Atopic Dermatitis in the areas to be treated
* Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
* Clinically infected Atopic Dermatitis at baseline
* Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
* Known hypersensitivity to macrolides or any excipient of either study medication
* Chronic condition which is either not stable or not well controlled
* 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: Birmingham
country: United States
state: Alabama
city: San Francisco
country: United States
state: California
city: Kansas City
country: United States
state: Kansas
city: Ann Arbor
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Halifax
country: Canada
state: Nova Scotia
city: Halifax
country: Canada
state: Nova Scotia
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use central contact
role: STUDY_DIRECTOR
References:
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.
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: Fleischer AB Jr, Abramovits W, Breneman D, Jaracz E; US/Canada tacrolimus ointment study group. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat. 2007;18(3):151-7. doi: 10.1080/09546630701287332.