Clinical trial NCT00106496: A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis
Official title: A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Treatment Effectiveness
Treatment Efficacy
Immunomodulator, Topical
Tacrolimus, Topical
Dermatitis, Atopic
Eczema, Atopic
Atopic Dermatitis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-03-28
Enrollment: 410
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis

Detailed description: Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.

Eligibility criteria: Inclusion Criteria:

* Patient must have Atopic Dermatitis
* Patient must be at least 2 years of age

Exclusion Criteria:

* Patient is pregnant or breast feeding an infant

Primary outcomes:
measure: percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Percentage of patients reporting cutaneous adverse events overall
timeFrame: Day 4 through end of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Irvine
country: United States
facility: Investigational Site
state: California
city: Loma Linda
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: New Haven
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
facility: Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
facility: Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: Investigational Site
state: Missouri
city: Lebanon
country: United States
facility: Investigational Site
state: New Hampshire
city: New York
country: United States
facility: Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Investigational Site
state: Texas
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Breneman D, Fleischer AB Jr, Abramovits W, Zeichner J, Gold MH, Kirsner RS, Shull TF, Crowe AW, Jaracz E, Hanifin JM; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008 Jun;58(6):990-9. doi: 10.1016/j.jaad.2008.02.008. Epub 2008 Mar 21.
citation: Paller AS, Eichenfield LF, Kirsner RS, Shull T, Jaracz E, Simpson EL; US Tacrolimus Ointment Study Group. Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics. 2008 Dec;122(6):e1210-8. doi: 10.1542/peds.2008-1343. Epub 2008 Nov 17.