title: Calcipotriol plus betamethasone dipropionate gel compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized, controlled trial investigating efficacy and safety in a Chinese population.
abstract: BACKGROUND
  Calcipotriol/betamethasone dipropionate combination in a non-alcoholic, lipophilic gel formulation (two-compound gel) has previously been demonstrated as a safe and effective treatment for scalp psoriasis in Caucasian, Hispanic/Latino, and Black/African American populations. The purpose of this randomized, investigator-blinded, active-controlled, 4-week study was to evaluate the efficacy and safety of the two-compound gel in Chinese subjects with scalp psoriasis.
  
  
  METHODS
  Subjects were randomized in a 1 : 1 ratio to four weeks of treatment with either the two-compound gel once daily or calcipotriol scalp solution twice daily. Subjects were evaluated after one, two, and four weeks of treatment. The primary efficacy endpoint was the proportion of subjects who achieved "controlled disease" defined as "clear" or "minimal" disease according to investigator's global assessment of disease severity at week 4.
  
  
  RESULTS
  The proportion of subjects who achieved "controlled disease" at week 4 was statistically significantly higher in the two-compound gel group (87.5%) than in the calcipotriol solution group (50.8%), (P < 0.0001). Greater and more rapid improvements with the two-compound gel were also observed in clinical signs (redness, thickness, and scaliness) and itching. The two-compound gel was associated with fewer adverse drug reactions than calcipotriol scalp solution (18.6% vs. 33.1%) (P = 0.011).
  
  
  CONCLUSIONS
  The calcipotriol/betamethasone dipropionate gel applied once daily was significantly more effective and better tolerated than calcipotriol scalp solution applied twice daily in the treatment of scalp psoriasis over four weeks in Chinese subjects.
authors.affiliation: Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Li
authors.initials: L
authors.lastname: Ma
authors.affiliation: Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Qinping
authors.initials: Q
authors.lastname: Yang
authors.affiliation: Peking University First Hospital, Beijing, China.
authors.forename: Haizhen
authors.initials: H
authors.lastname: Yang
authors.affiliation: Xijing Hospital of The Fourth Military Medical University, Xian, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Second Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China.
authors.forename: Min
authors.initials: M
authors.lastname: Zheng
authors.affiliation: Southwest Hospital of Third Military Medical University, Chongqing, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Hao
authors.affiliation: Changhai Hospital of the Second Military Medical College, Shanghai, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Gu
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Qiuning
authors.initials: Q
authors.lastname: Sun
authors.affiliation: Chinese Academy of Medical Sciences, Nanjing Institute of Dermatology, Nanjing, China.
authors.forename: Pangen
authors.initials: P
authors.lastname: Cui
authors.affiliation: Beijing Hospital of the Ministry of Health, Beijing, China.
authors.forename: Mengliang
authors.initials: M
authors.lastname: Ge
authors.affiliation: Peking University First Hospital, Beijing, China.
authors.forename: Ruoyu
authors.initials: R
authors.lastname: Li
authors.affiliation: Xijing Hospital of The Fourth Military Medical University, Xian, China.
authors.forename: Tianwen
authors.initials: T
authors.lastname: Gao
authors.affiliation: LEO Pharma, Voisin-le-Bretonneux, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Facy
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Merle
authors.initials: M
authors.lastname: Kurvits
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xu
authors.affiliation: Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Jinhua
authors.initials: J
authors.lastname: Xu
mesh_terms: D000287:Administration, Topical; D000328:Adult; D044466:Asian People / Q000706:statistics & numerical data; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002681:China; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy* / Q000208:ethnology; D012536:Scalp Dermatoses / Q000175:diagnosis* / Q000188:drug therapy* / Q000208:ethnology; D012720:Severity of Illness Index; D012996:Solutions; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D012996:Solutions; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol