title: Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease.
abstract: OBJECTIVE
  Collagenase Clostridium histolyticum is an investigational nonsurgical treatment for Peyronie disease. In this phase 2b, double-blind, randomized, placebo controlled study we determined the safety and efficacy of collagenase C. histolyticum and assessed a patient reported outcome questionnaire.
  
  
  METHODS
  A total of 147 subjects were randomized into 4 groups to receive collagenase C. histolyticum or placebo (3:1) with or without penile plaque modeling (1:1). Per treatment cycle 2 injections of collagenase C. histolyticum (0.58 mg) were given 24 to 72 hours apart. Subjects received up to 3 cycles at 6-week intervals. When designated, investigator modeling was done 24 to 72 hours after the second injection of each cycle. We evaluated penile curvature by goniometer measurement, patient reported outcomes and adverse event profiles.
  
  
  RESULTS
  After collagenase C. histolyticum treatment significant improvements in penile curvature (29.7% vs 11.0%, p=0.001) and patient reported outcome symptom bother scores (p=0.05) were observed compared to placebo. In modeled subjects 32.4% improvement in penile curvature was observed in those on collagenase C. histolyticum compared to 2.5% worsening of curvature in those on placebo (p<0.001). Those treated with collagenase C. histolyticum who underwent modeling also showed improved Peyronie disease symptom bother scores (p=0.004). In subjects without modeling there were minimal differences between the active and placebo cohorts. Most adverse events in the collagenase C. histolyticum group occurred at the injection site and were mild or moderate in severity. No treatment related serious adverse events were reported.
  
  
  CONCLUSIONS
  Collagenase C. histolyticum treatment was well tolerated. We noted significant improvement in penile curvature and patient reported outcome symptom bother scores, suggesting that this may be a safe, nonsurgical alternative for Peyronie disease.
authors.affiliation: Urology Associates Medical Group, Burbank, California 91505, USA. mgelbard@ucla.edu
authors.forename: Martin
authors.initials: M
authors.lastname: Gelbard
authors.forename: Larry I
authors.initials: LI
authors.lastname: Lipshultz
authors.forename: James
authors.initials: J
authors.lastname: Tursi
authors.forename: Ted
authors.initials: T
authors.lastname: Smith
authors.forename: Greg
authors.initials: G
authors.lastname: Kaufman
authors.forename: Laurence A
authors.initials: LA
authors.lastname: Levine
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D006801:Humans; D007267:Injections; D008297:Male; D003012:Microbial Collagenase / Q000008:administration & dosage*; D008875:Middle Aged; D010411:Penile Induration / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D003012:Microbial Collagenase