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 <10 % under lrhSOD therapy, and patients satisfaction was high, also consequent to the lack of therapy-related side effects observed in the present study.
LrhSOD is an easily administrable, safe and effective local therapeutic for the painful phase of Peyronie's Disease.