NCT00689832

Protopic Ointment in Children Atopic Eczema

Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 487 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

Children with 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.

Detailed description

Treatments were to be applied twice daily 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. Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Tacrolimus 0.03%	ointment
DRUG	Fluticasone 0.005%	ointment

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2008-06-04
• Last updated: 2014-09-01

Locations

1 site across 1 country: France