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

J. H. Lee, C. J. Park, T. Y. Kim, Y. B. Choe, N. I. Kim, Hae Jun Song, J. I. Youn, S. W. Youn, J. H. Choi, K. J. Kim

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)483-489
Number of pages7
JournalJournal of the European Academy of Dermatology and Venereology
Volume31
Issue number3
DOIs
Publication statusPublished - 2017 Mar 1

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

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