A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis

Phase 4

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: Protopic; Drug: Corticosteroid; Drug: placebo

• Registration Number: NCT00106496
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-03-25
• Study First Submitted QC: 2005-03-25
• Study First Posted: 2005-03-28
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3A	Protopic	-
1B	Corticosteroid	-
1A	Protopic	-
2	Protopic	Open label
3B	placebo	-
4	Protopic	Open label

Primary Outcome Measures

Name	Time	Method
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment	2 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients reporting cutaneous adverse events overall	Day 4 through end of study

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Dallas, Texas, United States