Liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease: a randomized placebo-controlled double-blind prospective clinical study.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
LrhSOD is an easily administrable, safe and effective local therapeutic for the painful phase of Peyronie's Disease.
Riedl
Claus R
CR
Department of Urology, Thermenklinikum Baden, Austria, Wimmergasse 19, 2500 Baden, Austria. claus.riedl@thermenklinikum-baden.at
Sternig
Peter
P
Gallé
Günter
G
Langmann
Florian
F
Vcelar
Brigitta
B
Vorauer
Karola
K
Wagner
Andreas
A
Katinger
Hermann
H
Pflüger
Heinz
H
D018592:Cross-Over Studies; D018450:Disease Progression; D004311:Double-Blind Method; D004387:Dupuytren Contracture / Q000188:drug therapy / Q000201:enzymology / Q000473:pathology; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D006801:Humans; D008081:Liposomes; D008297:Male; D010147:Pain Measurement; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects; D010411:Penile Induration / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D011446:Prospective Studies; D013482:Superoxide Dismutase / Q000008:administration & dosage* / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome
D016166:Free Radical Scavengers; D008081:Liposomes; D013482:Superoxide Dismutase