NCT00690105

Protopic Ointment in Adult Atopic Eczema of the Face

Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment.

Detailed description

Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	tacrolimus 0.1%	ointment
DRUG	fluticasone 0.005 %	ointment

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2008-06-04
• Last updated: 2014-09-01

Locations

1 site across 1 country: France