A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis
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
1 other identifier
interventional
410
1 country
24
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2004
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 25, 2005
CompletedFirst Posted
Study publicly available on registry
March 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedSeptember 18, 2014
September 1, 2014
1.7 years
March 25, 2005
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
2 weeks
Secondary Outcomes (1)
Percentage of patients reporting cutaneous adverse events overall
Day 4 through end of study
Study Arms (6)
1A
EXPERIMENTAL1B
ACTIVE COMPARATOR2
EXPERIMENTALOpen label
3A
EXPERIMENTAL3B
PLACEBO COMPARATOR4
EXPERIMENTALOpen label
Interventions
Eligibility Criteria
You may qualify if:
- Patient must have Atopic Dermatitis
- Patient must be at least 2 years of age
You may not qualify if:
- Patient is pregnant or breast feeding an infant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Investigational Site
Birmingham, Alabama, 35205, United States
Investigational Site
Irvine, California, 92697, United States
Investigational Site
Loma Linda, California, 92354, United States
Investigational Site
San Diego, California, 92123, United States
Unknown Facility
New Haven, Connecticut, 06519, United States
Unknown Facility
Miami, Florida, 33136, United States
Investigational Site
Atlanta, Georgia, 30322, United States
Investigational Site
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Investigational Site
Chicago, Illinois, 60614, United States
Unknown Facility
Lexington, Kentucky, 40536, United States
Unknown Facility
Baltimore, Maryland, 21205, United States
Investigational Site
Ann Arbor, Michigan, 48109, United States
Investigational Site
Detroit, Michigan, 48202, United States
Investigational Site
St Louis, Missouri, 63110, United States
Investigational Site
Lebanon, New Hampshire, 03756, United States
Investigational Site
New York, New York, 10029, United States
Investigational Site
Winston-Salem, North Carolina, 27157, United States
Investigational Site
Cincinnati, Ohio, 45219, United States
Investigational Site
Portland, Oregon, 97201, United States
Investigational Site
Philadelphia, Pennsylvania, 19115, United States
Investigational Site
Nashville, Tennessee, 37215, United States
Investigational Site
Dallas, Texas, 75230, United States
Investigational Site
Dallas, Texas, 75390, United States
Related Publications (2)
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.
PMID: 18359127BACKGROUNDPaller 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.
PMID: 19015204BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2005
First Posted
March 28, 2005
Study Start
October 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
September 18, 2014
Record last verified: 2014-09