An alcohol-free aerosol foam that contains a fixed combination of calcipotriene 0.005% plus betamethasone dipropionate 0.064% provided rapid itch relief and was well tolerated in patients with psoriasis vulgaris, according to results from a randomized, phase III study.
In earlier phase II studies, the product, which is being developed by Denmark-based LEO Pharma, was shown to be effective and had a safe tolerability profile, with no clinically relevant impact on the hypothalamic-pituitary-adrenal axis or on calcium metabolism. In an effort to confirm the efficacy and safety profile seen in the phase II trials, researchers led by Dr. Craig Leonardi, a dermatologist at Saint Louis (Mo.) University, performed the phase III study to compare the aerosol foam product with vehicle when applied once daily for up to 4 weeks in patients with psoriasis vulgaris.
Reporting in the December 2015 issue of the Journal of Drugs in Dermatology, Dr. Leonardi and his associates at 27 outpatient sites enrolled 426 patients aged 18 years and older between June and October of 2013 in a trial known as PSO-FAST (Cal/BD Foam in Psoriasis Vulgaris, a Four-Week, Vehicle-Controlled, Efficacy, and Safety Trial). The primary outcome was the proportion of patients who achieved treatment success at week 4, based on the physician’s global assessment, which was defined as clear or almost clear (for patients with at least moderate disease at baseline) or clear (for patients who had mild disease at baseline). Secondary outcomes included a modified (excluding head) Psoriasis Area and Severity Index (mPASI) and patient’s assessment of itch based on a visual analog scale(J. Drugs Dermatol. 2015;14[12]:1468-77).
Of the 426 patients, 323 received the aerosol foam product, while 103 received the vehicle. Their median age was 51 years, 59% were male, and their mean body mass index was 32.3 kg/m2. At week 4, the researchers found that significantly more patients in the aerosol foam group achieved treatment success, compared with those in the vehicle group (53.3% vs. 4.8%, respectively; odds ratio 30.3; P less than .001).
In addition, the mean mPASI score was significantly lower among patients in the aerosol foam group, compared with those in the vehicle group (a score of 2.0 vs. 5.5, for an adjusted difference of –3.3; P less than .001).
Among the 96% of patients who reported any level of itch at baseline, 36.8% in the aerosol foam group reported a 70% reduction in itch at day 3, compared with 24% of those in the vehicle group (OR 1.9; P = .018).
“This trial also demonstrated itch alleviation led to significant reductions in sleep loss, with 70.8% of patients using Cal/BD aerosol foam reporting a 70% reduction in itch-related sleep loss by week 4,” the researchers wrote.
No clinically significant changes in mean albumin-corrected serum calcium or urinary calcium to creatinine ratio was observed in either group. The researchers concluded that the Cal/DB aerosol foam product “may be a beneficial treatment option for those patients who are candidates for therapy with a superpotent steroid, but desire a therapeutic safety profile similar to that of a less potent steroid.”