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
Overview
- Phase
- Phase 4
- Intervention
- Protopic
- Conditions
- Dermatitis, Atopic
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 410
- Locations
- 1
- Primary Endpoint
- percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Arms & Interventions
4
Open label
Intervention: Protopic
3B
Intervention: placebo
1A
Intervention: Protopic
1B
Intervention: Corticosteroid
2
Open label
Intervention: Protopic
3A
Intervention: Protopic
Outcomes
Primary Outcomes
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
Time Frame: 2 weeks
Secondary Outcomes
- Percentage of patients reporting cutaneous adverse events overall(Day 4 through end of study)