A Phase 4 interventional study of Protopic and Corticosteroid in Dermatitis, Atopic, sponsored by Astellas Pharma Inc. Completed at 24 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2014-09-18.
Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment
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
Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 410 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Protopic
Drug: Corticosteroid
Open label
Drug: Protopic
Drug: Protopic
Drug: placebo
Open label
Drug: Protopic
topical
Also known as: tacrolimus ointment, FK506 ointment
topical
topical
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
Time frame: 2 weeks
Percentage of patients reporting cutaneous adverse events overall
Time frame: Day 4 through end of study
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc