Efficacy and safety of the XXXX 0.1% plaster in mild-to-moderate @entity102 : a randomized, parallel-group, active-controlled, phase III study.

@entity1 @entity17834 @entity1899 @entity1569 @entity102 @entity111 @entity288
BACKGROUND: @entity288 are a versatile option for the treatment of mild-to-moderate @entity1569 due to their availability in a wide range of potencies and formulations. Occlusion of the corticosteroid is a widely accepted procedure to enhance the penetration of the medication, thereby improving its effectiveness. @entity17834 ( @entity1899 ) is a moderately potent corticosteroid that is available as a cream, ointment, and lotion. A ready-to-use occlusive dressing, which provides a continuous sustained release of @entity1899 , has been developed for the treatment of @entity1569 . OBJECTIVE: To evaluate the efficacy and safety of a new @entity1899 0.1% plaster compared with a @entity1899 0.1% cream in @entity1 with mild-to-moderate @entity102 . METHODS: This was a prospective, randomized, assessor-blind, parallel-group, active-controlled, multicenter, phase III study. Eligible outpatients (aged >= 18 years) with a diagnosis of stable, chronic @entity1569 with two to four plaques on extensor surfaces of limbs were randomized to receive @entity1899 0.1% plaster or @entity1899 0.1% cream for 3-5 weeks; @entity1 with resolution of target plaques then entered a 3-month, treatment-free, follow-up period. The number of @entity1 showing clearing of plaques (remission) at 3 weeks (primary endpoint) and at 5 weeks was independently evaluated from digitized images of target plaques by two blinded assessors, and also assessed by the investigator and @entity1 . Additional endpoints were (i) change from baseline in target plaque size and in Psoriasis Global Assessment (PGA) score, as evaluated by the blinded assessors, investigator, and @entity1 ; (ii) change from baseline in symptom ( @entity111 , soreness) severity; (iii) treatment satisfaction and ease of use; (iv) clearing and relapse during the follow-up period; and (v) adverse events (AEs). RESULTS: @entity1 (n   =   231) were screened and randomized to treatment with @entity1899 0.1% plaster (n   =   116) and @entity1899 0.1% cream (n   =   115). Significantly more @entity1 achieved clearing after 3 weeks' treatment with @entity1899 plaster than with @entity1899 cream (Cochran-Mantel-Haenszel test, p   <   0.001); this difference was maintained at 5 weeks. The total plaque area decreased to a larger extent for the @entity1899 plaster group compared with the @entity1899 cream group (analysis of covariance [ANCOVA] model, p   =   0.017 at week 5). PGA scores were significantly lower after 3 and 5 weeks' treatment with @entity1899 plaster (ANCOVA model, all p    <=   0.016 vs @entity1899 cream). Both treatments reduced @entity111 and soreness to a similar degree, and the incidences of relapse during the follow-up period were comparable between treatment groups. There were no significant differences in AEs between treatment groups. CONCLUSIONS: @entity1899 0.1% plaster is more efficacious than @entity1899 0.1% cream in the treatment of @entity1 with mild-to-moderate @entity102 in a clinical setting resembling daily clinical practice.
