title: Optimal maintenance treatment with calcipotriol/betamethasone dipropionate gel in Korean patients with psoriasis vulgaris: a multicentre randomized, controlled clinical trial.
abstract: BACKGROUND
  There is a lack of response data for topical treatments for psoriasis vulgaris in Asian patients.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: J-H
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Dermatology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
authors.forename: C-J
authors.initials: CJ
authors.lastname: Park
authors.affiliation: Department of Dermatology, St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
authors.forename: T-Y
authors.initials: TY
authors.lastname: Kim
authors.affiliation: Department of Dermatology, Konkuk University School of Medicine, Seoul, South Korea.
authors.forename: Y-B
authors.initials: YB
authors.lastname: Choe
authors.affiliation: Department of Dermatology, College of Medicine, Kyung Hee University, Seoul, South Korea.
authors.forename: N-I
authors.initials: NI
authors.lastname: Kim
authors.affiliation: Department of Dermatology, Guro Hospital, College of Medicine, Korea University, Seoul, South Korea.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Song
authors.affiliation: Department of Dermatology, National Medical Center, Seoul, South Korea.
authors.forename: J-I
authors.initials: JI
authors.lastname: Youn
authors.affiliation: Department of Dermatology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
authors.forename: S-W
authors.initials: SW
authors.lastname: Youn
authors.affiliation: Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: J-H
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Department of Dermatology, Hallym University Sacred Heart Hospital, Anyang, South Korea.
authors.forename: K-J
authors.initials: KJ
authors.lastname: Kim
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D060828:Induction Chemotherapy; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011537:Pruritus / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy*; D012074:Remission Induction; D056910:Republic of Korea; D012720:Severity of Illness Index
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; C517164:betamethasone dipropionate, calcipotriol drug combination; D001623:Betamethasone; D002117:Calcitriol