Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie's Disease: A Randomized Placebo-Controlled Double-Blind Prospective Clinical Study

• Published in: European urology 2005-10, Vol.48 (4), p.656-661
• Main Authors: Riedl, Claus R., Sternig, Peter, Gallé, Günter, Langmann, Florian, Vcelar, Brigitta, Vorauer, Karola, Wagner, Andreas, Katinger, Hermann, Pflüger, Heinz
• Format: Article
• Language: English
• Subjects: Controlled clinical trial; Cross-Over Studies; Disease Progression; Double-Blind Method; Dupuytren Contracture - drug therapy; Dupuytren Contracture - enzymology; Dupuytren Contracture - pathology; Free Radical Scavengers - administration & dosage; Humans; Liposomes; Local therapy; Male; Medical therapy; Pain Measurement; Patient Satisfaction; Penile Erection - drug effects; Penile Induration - drug therapy; Penile Induration - enzymology; Penile Induration - pathology; Peyronie's disease; Prospective Studies; Superoxide dismutase; Superoxide Dismutase - administration & dosage; Superoxide Dismutase - drug effects; Time Factors; Treatment Outcome
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2005.04.011

To demonstrate the efficacy and safety of a topical gel containing liposomally encapsulated recombinant human Superoxide Dismutase (lrhSOD) in the treatment of painful Peyronie's Disease. The theoretical background is that lrhSOD, by scavenging of free oxygen radicals, might interrupt inflammatory cascades and thereby limit further disease progression. In a placebo-controlled randomized clinical trial, 39 patients with Peyronie's Disease and significant pain symptoms were treated with lrhSOD or placebo for a 4 week period. At this time, statistical evaluation of pain resolution was performed as primary study endpoint. Patients then were continued in a cross-over study design to ensure a total of 8 weeks of lrhSOD therapy for all study participants. Pain, plaque and curvature assessment was performed at study entry and every 4 weeks until week 12. LrhSOD treatment resulted in a statistically significant reduction of pain ( p = 0.017) compared to placebo already after 4 weeks. At week 12 pain was significantly reduced in 89% of patients who all had received 8 weeks of lrhSOD therapy at that time. Response to other disease parameters was assessed at week 12: plaque size was reduced in 47% of patients, as was plaque consistence in 38%. Penile curvature was improved at 5–30 degrees in 23% of patients. The expected spontaneous disease progression rate of up to 40%, as reported by several investigators, was significantly reduced to