In addition, a retrospective analysis of data from six phase 3, double-blind studies found that more patients treated with calcipotriol/betamethasone dipropionate ointment achieved PASI 75 than patients treated with individual components, regardless of baseline disease severity. FoamThe foam formulation has been studied in two pivotal, randomized, double-blind trials in patients with mild to severe plaque psoriasis. In the first study (randomized, phase 2) of 302 patients with body and scalp psoriasis, more patients treated with calcipotriol/betamethasone dipropionate (Cal/BD) foam achieved clear or  almost clear disease (45%) according to the IGA by 4 weeks compared with Cal 50 mcg/g or BD 0.5 mg/g (15% and 31%, respectively). In a second study (randomized, phase 3) of patients with psoriasis on the body (N=426), a significantly greater proportion of patients treated with once-daily Cal/BD foam achieved clear or almost clear disease (53.3%) vs. those receiving the vehicle control (4.8%). Mean modified PASI score was also significantly lower for patients treated with Cal/BD foam compared with vehicle (2.0 vs 5.5, respectively, at week 4), and itch relief was significantly greater in patients using the Cal/BD foam beginning at day 3. A recent study compared the Cal/BD foam formulation with the ointment formulation in patients with mild to severe psoriasis. At 4 weeks, significantly more patients achieved treatment success, defined as clear or almost clear disease according to the IGA with Cal/BD foam (54.6%) versus the ointment (43.0%). However, pronounced itch relief occurred quickly and was maintained throughout the 4-week study duration with both formulations.
Effects on calcium metabolism
In patients treated with both calcipotriol/betamethasone dipropionate (Cal/BD) ointment on the body and Cal/BD topical suspension on the scalp (n=35), 1 patient (2.9%) had elevated urinary calcium levels after 4 weeks of treatment.Three studies of Cal/BD topical suspension have evaluated treatment effects on calcium metabolism. In 2 of the 3 trials (n=32 and n=43), elevated urinary calcium levels outside the normal range were observed in 2 patients each. In the third trial (n=109), no clinically relevant changes in urinary calcium were reported.Potential effects on calcium metabolism have been evaluated in three randomized, multicenter, prospective, vehicle- and/or active-controlled trials of the foam formulation enrolling 564 adults with plaque psoriasis. The foam was applied once daily for four weeks. In these trials, three subjects had serum calcium levels elevated above the upper limit of normal. Urinary calcium elevations above normal were reported in 17 subjects.In a published multicenter, open-label, single-arm trial of the foam formulation, 35 adults with plaque psoriasis applied the foam once daily to all lesions on the trunk, limbs, and scalp for four weeks. No elevations of serum calcium, urinary calcium, or the ratio of urinary calcium to creatinine above the upper limit of normal were observed. History
The combination was developed by LEO Pharma. To combine them, new non-aqueous non-alcohol formulations had to be found to avoid mutual degradation of the two active substances while also achieving the desired skin absorption.