Study design
The safety and efficacy of Wynzora cream were evaluated in a randomized, multicenter, noninferiority, vehicle- and active comparator–controlled clinical trial (NCT03308799) in adult subjects with mild to moderate plaque psoriasis. In the trial, 794 subjects were randomized to 1 of 3 treatment groups: Wynzora cream, vehicle cream, or calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064%. The majority of subjects in the trial (81.7%) had disease of moderate severity at baseline, while 18.3% of subjects had disease of mild severity. Disease severity was determined by a 5-grade Physician’s Global Assessment (PGA) scale.
The primary efficacy endpoint was the proportion of subjects with treatment success at week 8. Treatment success was defined as at least a 2-grade improvement from baseline in the PGA score and a PGA score equating to “clear” or “almost clear.” Other evaluated outcomes included a reduction in itch as defined by at least a 4-point improvement in the 11-point Peak Pruritus Numeric Rating Scale (NRS) from baseline to week 4.1