Clinical Trial: Protopic Ointment in Children Atopic Eczema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


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 modified Eczema Area and Severity Index (mEASI) in comparison to day 1 [ Time Frame: 3 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • mEASI and EASI scores at each visit and percentage change with respect to day 1 [ Time Frame: 1 week and 3 weeks ]
  • Global assessment of clinical response by the physician at each visit after day 1 [ Time Frame: 1 week and 3 weeks ]
  • Global assessment of clinical response by the patient/parents at each visit after day 1 [ Time Frame: 1 week and 3 weeks ]
  • All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit [ Time Frame: 1 week and 3 weeks ]
  • Compliance with the treatment assessed from the patient's diary [ Time Frame: 1 week and 3 weeks ]
  • Patient's quality of life assessed at day 1 and day 21 [ Time Frame: 3 weeks ]
  • Incidence of adverse events during the study [ 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