title: A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus.
abstract: BACKGROUND
  In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE).
  
  
  OBJECTIVE
  To compare the efficacy and safety of R-salbutamol cream 0.5% vs. placebo on DLE lesions in a multicentre, double-blinded, randomized, placebo-controlled phase II trial.
  
  
  METHODS
  Thirty-seven patients with at least one newly developed DLE lesion were randomized - 19 to the R-salbutamol cream 0.5% and 18 to placebo - and treated twice daily for 8 weeks. Efficacy was evaluated through scores of erythema, scaling/hypertrophy and induration as well as pain and itching; general improvement scored by the investigator and global improvement scored by patients' assessment were also evaluated.
  
  
  RESULTS
  The mean area under the curve of improvement for scaling/hypertrophy, pain, itching and global patient assessment was significantly better for the actively treated patients as compared with placebo (scaling/hypertrophy, P = 0.0262; pain, P = 0.0238; itching, P = 0.0135; global patient assessment, P = 0.045). Moreover, the percentage of patients without induration was significantly higher in the active group compared with the placebo group (P = 0.013), and a statistically significantly greater decrease in the size of the lesional area was also seen in the overall analysis of the R-salbutamol-treated patients (P = 0.0197). No serious adverse events were reported.
  
  
  CONCLUSIONS
  Application of R-salbutamol cream 0.5% was safe and well tolerated. Statistically significant effects were seen on scaling/hypertrophy, induration, pain and itching as well as patient global assessment, suggesting that R-salbutamol could be a promising new topical therapy alternative for DLE.
authors.affiliation: Department of Dermatology, Health Sciences Faculty, University of Copenhagen, Roskilde Hospital, Roskilde, Denmark. gbj@regionsjaelland.dk
authors.forename: G B E
authors.initials: GB
authors.lastname: Jemec
authors.forename: S
authors.initials: S
authors.lastname: Ullman
authors.forename: M
authors.initials: M
authors.lastname: Goodfield
authors.forename: A
authors.initials: A
authors.lastname: Bygum
authors.forename: A B
authors.initials: AB
authors.lastname: Olesen
authors.forename: J
authors.initials: J
authors.lastname: Berth-Jones
authors.forename: F
authors.initials: F
authors.lastname: Nyberg
authors.forename: M
authors.initials: M
authors.lastname: Cramers
authors.forename: J
authors.initials: J
authors.lastname: Faergemann
authors.forename: P
authors.initials: P
authors.lastname: Andersen
authors.forename: A
authors.initials: A
authors.lastname: Kuhn
authors.forename: T
authors.initials: T
authors.lastname: Ruzicka
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008179:Lupus Erythematosus, Discoid / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011537:Pruritus / Q000188:drug therapy* / Q000523:psychology; D012869:Skin Absorption; D013237:Stereoisomerism; D016896:Treatment Outcome
chemical_list: D000420:Albuterol