title: Double-blind, vehicle-controlled, multicenter comparison of two 0.025% tretinoin creams in patients with acne vulgaris.
abstract: BACKGROUND
  Preclinical study and human patch tests indicate polyolprepolymer-2 may reduce cutaneous tretinoin-induced irritation.
  
  
  OBJECTIVE
  This study compared the clinical efficacy and safety of a 0.025% tretinoin cream containing polyolprepolymer-2 and its vehicle to a commercially-available 0.025% tretinoin cream.
  
  
  METHODS
  In this 12-week multicenter, double-blind, parallel group study in patients with mild to moderate acne, objective lesion counts and the investigators' global evaluations evaluated efficacy. Subjective evaluations of skin irritation were used to study safety.
  
  
  RESULTS
  A total of 271 patients were enrolled. The active treatments demonstrated comparable efficacy that was statistically significantly greater than that of the vehicle. Safety evaluations of cutaneous and noncutaneous adverse events also indicated comparable results of the active treatments.
  
  
  CONCLUSIONS
  The commercially-available 0.025% tretinoin cream and the 0.025% tretinoin cream containing polyolprepolymer-2 demonstrated comparable efficacy and safety.
authors.affiliation: Dermatology Research Associates, Cincinnati, Ohio 45230, USA.
authors.forename: A W
authors.initials: AW
authors.lastname: Lucky
authors.forename: S I
authors.initials: SI
authors.lastname: Cullen
authors.forename: T
authors.initials: T
authors.lastname: Funicella
authors.forename: M T
authors.initials: MT
authors.lastname: Jarratt
authors.forename: T
authors.initials: T
authors.lastname: Jones
authors.forename: M E
authors.initials: ME
authors.lastname: Reddick
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D008297:Male; D009824:Ointments; D011126:Polypropylenes / Q000008:administration & dosage; D011140:Polyurethanes / Q000008:administration & dosage; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry
chemical_list: D007641:Keratolytic Agents; D009824:Ointments; D011126:Polypropylenes; D011140:Polyurethanes; C109905:polyolprepolymer-2; D014212:Tretinoin