title: Pilot study on liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease.
abstract: OBJECTIVE
  To assess the efficacy and safety of liposomally encapsulated recombinant human superoxide dismutase (lrhSOD) for the treatment of Peyronie's disease.
  
  
  METHODS
  In an uncontrolled phase-2 study, 20 patients with Peyronie's disease were treated with a gel containing lrhSOD (1.5 mg/g). Patients with penile deviation of >45 degrees or plaque calcifications of >5 mm were regarded as candidates for surgical correction and excluded from this study.
  
  
  RESULTS
  Elimination of pain was observed in 7/13 patients (in 2 patients after only 3 days of therapy), and an almost complete resolution of pain was reported by the remaining 6/13 patients. Plaque size was reduced in 8/14 patients. Minimal improvement of penile deviation was observed in 3/12 patients. Post-therapeutic improvement of sexual function, mainly due to cessation of pain, was reported by 12/15 patients. No systemic or local side effects were observed.
  
  
  CONCLUSIONS
  In the present study, 100% pain relief as well as a plaque size reduction in 56% of Peyronie's disease patients were observed after a maximum of 6 weeks of lrhSOD therapy. The convenience and safety of lrhSOD gel therapy were superior compared to other current regimens. The present results suggest that lrhSOD gel is a promising treatment for patients with early stage Peyronie's disease. Early institution of lrhSOD therapy may prevent disease progression to penile deviation. The present preliminary results are the basis of a placebo-controlled randomized study.
authors.affiliation: Department of Urology and Ludwig Boltzmann Institute of Andrology, Municipal Hospital Lainz, Vienna, Austria. ric@uro.khl.magwien.gv
authors.forename: C R
authors.initials: CR
authors.lastname: Riedl
authors.forename: E
authors.initials: E
authors.lastname: Plas
authors.forename: K
authors.initials: K
authors.lastname: Vorauer
authors.forename: B
authors.initials: B
authors.lastname: Vcelar
authors.forename: A
authors.initials: A
authors.lastname: Wagner
authors.forename: H
authors.initials: H
authors.lastname: Pflüger
mesh_terms: D000328:Adult; D000368:Aged; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D010411:Penile Induration / Q000188:drug therapy*; D010865:Pilot Projects; D011994:Recombinant Proteins; D013482:Superoxide Dismutase / Q000008:administration & dosage*
chemical_list: D016166:Free Radical Scavengers; D008081:Liposomes; D011994:Recombinant Proteins; D013482:Superoxide Dismutase