PURPOSE: Collagenase Clostridium histolyticum is an investigational nonsurgical treatment for @entity545 . In this phase 2b, double-blind, randomized, placebo controlled study we determined the safety and efficacy of collagenase C. histolyticum and assessed a @entity1 reported outcome questionnaire. MATERIALS AND 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 @entity546 by goniometer measurement, @entity1 reported outcomes and adverse event profiles. RESULTS: After collagenase C. histolyticum treatment significant improvements in @entity546 (29.7% vs 11.0%, p=0.001) and @entity1 reported outcome symptom bother scores (p=0.05) were observed compared to placebo. In modeled subjects 32.4% improvement in @entity546 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 @entity545 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 @entity546 and @entity1 reported outcome symptom bother scores, suggesting that this may be a safe, nonsurgical alternative for @entity545 .

Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in @entity1 with XXXX .

@entity1 :: ('9606', 'Species') :: ['patient'] @entity545 :: ('MESH:D010411', 'Disease') :: ['Peyronie disease'] @entity546 :: ('MESH:D004414', 'Disease') :: ['penile curvature']
@entity545 :: (MESH:D010411,Disease) :: ['Peyronie disease']
