CAL/BDP cream more efficacious, convenient than gel formulation

Psoriasis patients treated with a cream formulation of calcipotriene and betamethasone dipropionate developed with PAD technology showed significant improvement over those treated with a suspension gel formulation, study results showed.

“A trusted and well-known topical treatment of plaque psoriasis is the fixed-dose combination of calcipotriene (CAL; vitamin D analogue) and betamethasone dipropionate (BDP; corticosteroid),” April W. Armstrong, MD, of the University of Southern California, and colleagues wrote. “In an aqueous environment, CAL and BDP are incompatible because CAL requires basic conditions to maintain stability, whereas betamethasone requires acidic conditions. Therefore, the already marketed CAL/BDP fixed-dose combination products are nonaqueous paraffin or liquid oil-based formulations, which can be sticky, greasy and inconvenient to use for many patients.”

CAL/BDP PAD cream (Wynzora, MC2 Therapeutics) is a nongreasy, aqueous formula created with PAD technology to protect the drugs from degradation during storage.

Two phase three, randomized, investigator-blinded, multicenter, vehicle and comparator-controlled trials enrolled 796 and 490 patients, respectively.

Both trials randomly assigned patients 3:1:3 to receive CAL/BDP PAD, vehicle or CAL/BDP suspension/gel. Application was once a day for 8 weeks.

Of those patients, 526 in the CAL/BDP PAD, 513 of the CAL/BDP gel group and 149 of the vehicle group completed the trial.

Subject Global Assessment (SGA) success was defined as a decrease from baseline of at least 2 points to 0 or 1 (clear or very mild) on the SGA 5-point scale.

At week 4, 24.4% of the CAL/BDP PAD group achieved success, compared with 16.8% of the CAL/BDP gel group. At week 6, 35.6% and 25.1% achieved success and at week 8 it was 44.2% and 27.9%, respectively.

Dermatology Life Quality Index scores were also significantly improved in the treatment group with a mean improvement of –5.8 in the CAL/BDP PAD group compared with –5 in the CAL/BDP gel group at week 4, and a mean improvement of –6.5 in the CAL/BDP PAD group and –5.6 in the CAL/BDP gel group at week 8.

Impact and convenience of the treatment, as measured by the Psoriasis Treatment Convenience Scale questionnaire, found significantly greater satisfaction with the CAL/BDP PAD group compared with the CAL/BDP gel group (40.4 vs. 37).

“Patient-reported outcomes from these trials demonstrate that the CAL/BDP PAD-cream generally offers greater patient satisfaction when compared to the CAL/BDP suspension/gel,” the authors wrote. “These data provide hope that treatment with CAL/BDP PAD-cream may ultimately lead to better treatment outcomes than alternative products with lower patient acceptability.”