title: Efficacy and safety of topical WBI-1001 in patients with mild to severe atopic dermatitis: results from a 12-week, multicentre, randomized, placebo-controlled double-blind trial.
abstract: BACKGROUND
  There is a need for the development of novel nonsteroidal topical drugs for the treatment of atopic dermatitis (AD).
  
  
  OBJECTIVE
  The primary objective was to evaluate the efficacy of WBI-1001 over 6 weeks of treatment of mild to severe AD.
  
  
  METHODS
  Patients with AD affecting 3-20% of their body surface area and with an Investigator's Global Assessment (IGA) of 2-4 were randomized (1 : 1 : 1) to receive placebo, WBI-1001 0·5% or WBI-1001 1·0% in a cream formulation applied twice daily for 6 weeks. At the end of this phase, patients receiving WBI-1001 continued the same treatment for an additional 6 weeks. Patients receiving placebo entered into a 6-week double-blind phase with re-randomization (1 : 1) to WBI-1001 0·5% or 1·0% cream. The primary objective was to evaluate the efficacy of WBI-1001 over 6 weeks of treatment of mild to severe AD. The primary endpoint was the mean change from baseline in IGA at day 42 (week 6).
  
  
  RESULTS
  In total, 148 patients were randomized and analysed in the placebo (51), WBI-1001 0·5% (50) and WBI-1001 1·0% (47) groups. There was a decrease of 1·3 [43%; P < 0·001; 95% confidence interval (CI) -1·2 to -0·5] and 1·8 (56·3%; P < 0·001; 95% CI -1·6 to -0·9) in IGA at day 42 in the WBI-1001 0·5% and 1·0% groups, respectively, as compared with a decrease of 0·5 (14·7%) in the placebo group. Adverse drug reactions included a few cases of folliculitis and contact dermatitis.
  
  
  CONCLUSIONS
  WBI-1001 is an efficacious novel topical anti-inflammatory molecule for the treatment of AD.
authors.affiliation: Innovaderm Research Inc., Montreal, QC H2K 4L5, Canada. rbissonnette@innovaderm.ca
authors.forename: R
authors.initials: R
authors.lastname: Bissonnette
authors.forename: Y
authors.initials: Y
authors.lastname: Poulin
authors.forename: Y
authors.initials: Y
authors.lastname: Zhou
authors.forename: J
authors.initials: J
authors.lastname: Tan
authors.forename: H C
authors.initials: HC
authors.lastname: Hong
authors.forename: J
authors.initials: J
authors.lastname: Webster
authors.forename: W
authors.initials: W
authors.lastname: Ip
authors.forename: L
authors.initials: L
authors.lastname: Tang
authors.forename: M
authors.initials: M
authors.lastname: Lyle
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004485:Eczema / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D012118:Resorcinols / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013267:Stilbenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009824:Ointments; D012118:Resorcinols; D013267:Stilbenes; C571829:tapinarof