NCT00106496

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Protopic	topical
DRUG	Corticosteroid	topical
DRUG	placebo	topical

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-03-28
• Last updated: 2014-09-18

Locations

24 sites across 1 country: United States