NCT01745159

Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.

Detailed description

This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.

Conditions

• Moderate/Severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	tacrolimus

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-12-10
• Last updated: 2014-08-05

Locations

4 sites across 1 country: China