Clinical Trial: Protopic Ointment in Adult Atopic Eczema of the Face
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary: 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.
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their local mEASI score (mLEASI) compared to Baseline (day 1). [ Time Frame: 3 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
- Assessment of facial pruritus at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
- Global assessment of clinical response on the 'face' by the physician at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
- Global assessment of clinical response on the 'face' by the patient at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
- Patient's quality of life at day 1 and day 21 [ Time Frame: 1 week and 3 weeks ]
- mLEASI score values at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
- Physician's assessment of individual signs [ Time Frame: 1 week and 3 weeks ]
- Quality of sleep at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
- Affected surface area assessment at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
- Number of patients using the ointment from the other group to treat facial lesions after day 21 [ Time Frame: 3 weeks ]
- Incidences of adverse events during the study period [ Time Frame: 6 weeks ]
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: June 2, 2008
Date Started: February 2004
Date Completion:
Last Updated: August 28, 2014
Last Verified: August 2014