Dermatitis, Atopic Clinical Trial
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 to Severe Atopic Dermatitis.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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