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Background  A ready‐to‐use betamethasone valerate 0.1% ( BMV ) dressing was found to be superior to placebo dressing and a reference 0.1%  BMV  cream in the treatment of patients with chronic plaque psoriasis ( CPP ).    Methods  This multicentre, prospective, randomized, investigator‐blinded, controlled, non‐inferiority trial compared the efficacy and safety of the  BMV  dressing to the calcipotriol–betamethasone dipropionate ( CBD ) ointment during a 4‐week treatment of patients with mild to moderate  CPP . The primary efficacy endpoint was the 4‐item psoriasis total severity score ( TSS ‐4) at week 4, and the associated non‐inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment ( PGA ) score and patients’ quality of life (QoL). Safety was assessed through adverse events ( AE ) reporting in each treatment group.    Results  Of 325 screened patients, 324 were randomized to  BMV  ( N  = 165) or  CBD  ( N  = 159), and were considered evaluable for the safety and intention‐to‐treat ( ITT ) efficacy analyses. Per protocol ( PP ) populations included 133 and 131 patients in the  BMV  and  CBD  groups respectively. The mean adjusted  TSS ‐4 significantly decreased through the study from baseline in both groups. The  PP  (primary) analysis of week 4 data revealed a −0.288 (95%  CI : −0.610 to 0.034) not significant between‐group difference in adjusted means, demonstrating non‐inferiority of  BMV  to  CBD . Non‐inferiority was also demonstrated in the  ITT  analysis. The  PGA  and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the  CBD  group at week 4, but no difference was observed at follow‐up. No safety or tolerability concerns were observed in either group.    Conclusions   BMV  dressing is non‐inferior to  CBD  ointment in patients with mild to moderate  CPP . Both treatments significantly improve patients’ psoriasis and QoL.

journal of the european academy of dermatology and venereology

Betamethasone valerate dressing is non‐inferior to calcipotriol–betamethasone dipropionate ointment in the treatment of patients with mild‐to‐moderate chronic plaque psoriasis: results of a randomized assessor‐blinded multicentre trial