title: Olumacostat glasaretil, a novel topical sebum inhibitor, in the treatment of acne vulgaris: A phase IIa, multicenter, randomized, vehicle-controlled study.
abstract: BACKGROUND
  Olumacostat glasaretil (OG) inhibits acetyl-coenzyme A carboxylase, the enzyme responsible for the first, rate-limiting step in de novo fatty acid synthesis. OG inhibited in vitro human sebocyte lipid production and reduced in vivo sebaceous gland size in hamster ears.
  
  
  OBJECTIVE
  Safety and efficacy of OG 7.5% gel were evaluated in patients with moderate to severe facial acne vulgaris.
  
  
  METHODS
  Patients were randomized (1:1) to twice-daily application of OG or vehicle for 12 weeks. Efficacy was measured through changes in lesion counts and improvement in acne severity scores.
  
  
  RESULTS
  A total of 108 patients received OG (n = 53) or vehicle (n = 55); these groups had mean baseline counts of 29.7 and 28.6 inflammatory and 40.9 and 38.8 noninflammatory lesions, respectively. At week 12, OG treatment showed greater reductions from baseline in inflammatory lesions (-63.9% vs -45.9%; P = .0006) and noninflammatory lesions (-48.1% vs -28.8%; P = .0025), and more patients with greater than or equal to 2-grade improvement in investigator global assessment score (24.5% vs 7.3%; P = .0070) than vehicle. Application-site adverse events (typically mild or moderate intensity) were more common with OG.
  
  
  CONCLUSIONS
  Larger trials are needed to optimize OG dosing and confirm the current results.
  
  
  CONCLUSIONS
  OG was well tolerated and showed evidence of efficacy, suggesting further development is warranted.
authors.affiliation: Innovaderm Research Inc, Montreal, Quebec, Canada. Electronic address: rbissonnette@innovaderm.ca.
authors.forename: Robert
authors.initials: R
authors.lastname: Bissonnette
authors.affiliation: Centre de Recherche Dermatologique du Quebec Metropolitain, Québec City, Quebec, Canada.
authors.forename: Yves
authors.initials: Y
authors.lastname: Poulin
authors.affiliation: Dermira Inc, Menlo Park, California.
authors.forename: Janice
authors.initials: J
authors.lastname: Drew
authors.affiliation: Dermira Inc, Menlo Park, California.
authors.forename: Hans
authors.initials: H
authors.lastname: Hofland
authors.affiliation: Windsor Clinical Research Inc, Windsor, Ontario, Canada.
authors.forename: Jerry
authors.initials: J
authors.lastname: Tan
mesh_terms: D000152:Acne Vulgaris / Q000175:diagnosis* / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D018579:Patient Selection; D011446:Prospective Studies; D012016:Reference Values; D012629:Sebum / Q000187:drug effects*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014212:Tretinoin
keywords: acetyl-coenzyme A carboxylase inhibitor; acne vulgaris; inflammatory lesions; investigator global assessment; local skin reactions; noninflammatory lesions; olumacostat glasaretil