Optimal maintenance treatment with calcipotriol/betamethasone dipropionate gel in Korean patients with psoriasis vulgaris: a multicentre randomized, controlled clinical trial

Background: There is a lack of response data for topical treatments for psoriasis vulgaris in Asian patients. Objectives: To determine the optimal maintenance regimen for topical treatment with calcipotriol monohydrate/betamethasone dipropionate gel in Korean patients with psoriasis vulgaris, by comparing the efficacy of three 8-week maintenance regimens. Methods: This was a multicentre, prospective, randomized, controlled, parallel-group, open-label, phase 4 clinical trial, conducted in South Korea. Patients with psoriasis vulgaris on the limbs/trunk received once-daily treatment with calcipotriol monohydrate (50 μg/g)/betamethasone dipropionate (500 μg/g) gel for 8 weeks (induction phase). Responders (defined as an Investigator's Global Assessment of Disease Severity (IGA) grade of ‘clear’ or ‘almost clear’) were then randomized to receive 8 weeks’ maintenance treatment with Xamiol^® gel once daily as needed [pro re nata (PRN Group)], once daily every day (Continuous group), or twice weekly – on Saturday and Sunday (Weekend group). The primary endpoint was the percentage of IGA responders at week 16. Results: At the end of the induction phase, 62.18% of patients were IGA responders. At the end of the maintenance phase (week 16), the responder rate was 63.89% for the PRN group, 67.5% for the Continuous group and 31.43% for the Weekend group. The PRN and Continuous groups were statistically superior to the Weekend group (P = 0.0109 and P = 0.0015), but the PRN and Continuous groups did not differ statistically. The incidence of adverse events did not differ significantly between the groups. Conclusion: Among Korean patients with psoriasis vulgaris, maintenance treatment with calcipotriol monohydrate/betamethasone dipropionate using a continuous daily regimen or an ‘as needed’ daily regimen provided similar efficacy, whereas a twice-weekly regimen was significantly less efficacious than either of these regimens.