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A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis

Journal of the European Academy of Dermatology and Venereology Oct 14, 2021

Pinter A, Green LJ, Selmer J, et al. - Topical treatment of plaque psoriasis with a novel fixed dose combination CAL(calcipotriol)/BDP(betamethasone dipropionate) PAD-cream (based on PAD Technology) provided greater efficacy, superior patient quality of life and equivalent favorable safety, relative to the currently available topical suspension/gel.

  • Pooling and analysis of data from two phase 3, multicenter, randomized, investigator-blind, active, and vehicle-controlled trials of patients with psoriasis was done.

  • A CAL/BDP cream based on PAD Technology (PAD-cream), an active control (marketed CAL/BDP topical suspension/gel: CAL/BDP TS), and cream vehicle, were applied once daily for 8 weeks.

  • Superiority for all efficacy endpoints was shown by the novel CAL/BDP PAD-cream formulation, and it afforded greater PGA treatment success (43.2%) than CAL/BDP TS (31.9%).

  • CAL/BDP PAD-cream provided 64.6% mean percent reduction in mPASI, vs 56.4% for CAL/BDP TS, and DLQI 0/1 was achieved by 43.8% in the CAL/BDP PAD-cream group vs 34.2% in the CAL/BDP TS group.

  • No adverse drug reaction was reported with a frequency of >1%, related to the CAL/BDP PAD-cream.

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