drugset / Trial / NCT00120302

Quality of Life Study in Adults With Facial Eczema

NCT00120302

Phase 4 Completed 76 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

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 Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study.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.

Timeline

Start
2005-03
Primary completion
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimecrolimus Small molecule 1 %

Indications