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