@entity12742 8% vs @entity3102 2% in the treatment of XXXX : a multicentre, randomized study.

@entity1 @entity2652 @entity3102 @entity5105 @entity12742 @entity1091 @entity1909
BACKGROUND: @entity1091 significantly improved @entity1909 in comparison with placebo. Objectives This randomized controlled trial was designed to show a non-inferiority of 15% (primary end-point) of @entity12742 8% ointment compared with @entity3102 2% emulsion. METHODS: The study population comprised out- @entity1 who had @entity2652 for at least 2 months, with moderate to severe @entity5105 and desquamation at inclusion. The primary end-point was complete remission, defined as the disappearance of both @entity5105 and desquamation. The non-inferiority of @entity1091 was assessed on the 95% confidence interval (CI) of the difference between treatments. RESULTS: The intent-to-treat analysis (ITT) involved 288 @entity1 and the per protocol (PP) analysis 269 @entity1 . Treatment groups were comparable at baseline on age, sex, disease duration and symptoms. For the main criterion, the success rate was 52.0% ( @entity1091 ) vs. 30.1% ( @entity3102 ) in the ITT population and 53.2% ( @entity1091 ) vs. 30.7% ( @entity3102 ) in the PP population. The non-inferiority of @entity1091 was demonstrated with differences of 21.9% (95% CI 10.0-33.7%) and 22.5% (95% CI 10.2-34.8%), respectively, in the ITT and PP population. As the lower limit of the 95% CI was > 0, the superiority of @entity1091 was shown. @entity1091 also showed better results on other symptoms: burning and dryness. Adverse events were reported by 26.3% ( @entity1091 ) and 25% ( @entity3102 ) of @entity1 . CONCLUSIONS: @entity1091 was 22% more effective than @entity3102 in giving complete remission of @entity1909 , with comparable safety.
