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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
577
ointment
ointment
Unnamed facility
Nice, France
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
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
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Time frame: 3 weeks
Incidences of adverse events during the study period
Time frame: 6 weeks