Efficacy of betamethasone valerate mousse in comparison with standard therapies on @entity11885 : an open, multicentre, randomized, controlled, cross-over study on 241 XXXX .

@entity1 @entity1569 @entity28583 @entity5935 @entity288 @entity9090 @entity2116 @entity18668 @entity10438 @entity560 @entity11885
BACKGROUND: The scalp is a common area for @entity1569 . Corticosteroid-based lotions are the most widely used therapy in this clinical setting. A new formulation of @entity5935 valerate 0.12% in a thermophobic, low-residue foam vehicle (Bettamousse trade mark, Mipharm, Italy; @entity18668 ) is available for the treatment of @entity28583 . OBJECTIVES: In an open, investigator-blinded, multicentre (28 dermatology clinics), randomized, cross-over study, the efficacy, safety and @entity1 acceptability of @entity18668 in @entity11885 were evaluated in comparison with standard therapies (ST, i.e. @entity288 or @entity560 analogues). ST were chosen by each centre according to its usual therapeutic protocols. METHODS: In total, 241 @entity1 with moderate to severe @entity11885 participated in the trial. After a 2-week run-in period, each active treatment ( @entity18668 or ST) was applied for 4 weeks, with a wash-out period between the two active treatment phases of at least 4 weeks. Efficacy was evaluated by investigators unaware of treatment sequence analysing a 'target' lesion for erythema, scaling, itching and burning using a five-point grading score. @entity1 treatment acceptability and assessment of the influence on Psoriasis Disability Index were evaluated using an eight-item modified Finlay-Khan questionnaire at baseline and at the end of each treatment period. Safety was evaluated by recording any adverse event occurring during the study duration. @entity18668 was applied twice daily, and ST were applied once or twice daily, according to the approved scheduled regimens. RESULTS: Analyses were by intention-to-treat. Two hundred and ten @entity1 concluded the study. Fifteen @entity1 withdrew from the study during @entity18668 treatment, and 16 during ST (not significantly different). Both treatments were well tolerated. At baseline, the mean +/- SD clinical global score (the 'Sum' score = erythema + scaling + itching + burning) was 7.6 +/- 2.6. The ST chosen were topical corticosteroids (55% of cases; mainly @entity10438 and @entity9090 ) or @entity2116 lotion (45% of cases). At the end of active treatments, @entity18668 was significantly superior to ST (P < 0.001) in reducing, as compared with baseline, the mean +/- SD Sum score (1.5 +/- 1.9 with @entity18668 and 3.1 +/- 2.7 with ST). During @entity18668 treatment, 88% (95% confidence interval, CI 82-94%) of @entity1 had a complete or nearly complete resolution of scaling in comparison with 66% (95% CI 58-74%) during ST therapy (P < 0.001). @entity18668 was also considered an easier and more convenient formulation to use in comparison with ST (P < 0.01). CONCLUSIONS: @entity18668 is more effective than lotion-based ST commonly used in the treatment of @entity11885 , and has higher @entity1 acceptability.
