NCT00120302

Quality of Life Study in Adults With Facial Eczema

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is not being conducted in the US. The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study. Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Pimecrolimus	Pimecrolimus cream 1 %
DRUG	Placebo	Matching vehicle cream

Timeline

• Start date: 2005-03-01
• Completion: 2006-01-01
• First posted: 2005-07-15
• Last updated: 2008-01-17

Locations

1 site across 1 country: United Kingdom