title: Topical treatment for acute phase Peyronie's disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study.
abstract: Safety and efficacy of topically applied gel H-100 composed of Nicardipine, superoxide dismutase and emu oil for treatment of acute phase Peyronie's disease (PD) was evaluated. Twenty-two patients (PD <12 months duration) were studied in a prospective, randomized, double-blind, placebo-controlled study. Eleven patients received H-100 and 11 patients received placebo for 3 months. All 22 patients then received H-100 for the final 3 months. Flaccid-stretched penile length, degree of penile curvature, pain level and side effects were assessed monthly. H-100 showed significant improvement in all PD parameters at 6 months: mean stretched penile length increase (22.6%, P=0.0002), mean curvature reduction (40.8%, P=0.0014), and mean pain level reduction (85.7%, P=0.004). Placebo group showed no significant improvement except for mean stretched penile length increase (6.8%, P=0.009). Crossover patients from placebo to H-100 showed significant improvement in all parameters: mean stretched penile length increase (17.5%, P=0.000007), mean curvature reduction (37.1%, P=0.006), and mean pain level reduction (40%, P=0.17). Treatment was well tolerated. A self-limited rash was the only side effect in three patients. Statistically significant improvements in flaccid-stretched penile length, curvature and pain suggest that H-100 is a safe and possibly effective non-invasive, topically applied treatment for acute phase Peyronie's Disease.
authors.affiliation: Urology Associates, Robbinsdale, MN, USA.
authors.forename: J
authors.initials: J
authors.lastname: Twidwell
authors.affiliation: Rush Medical College, Chicago, IL, USA.
authors.forename: L
authors.initials: L
authors.lastname: Levine
mesh_terms: D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D005782:Gels; D006801:Humans; D008297:Male; D009529:Nicardipine / Q000008:administration & dosage*; D009821:Oils; D010411:Penile Induration / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D013482:Superoxide Dismutase / Q000008:administration & dosage*
chemical_list: D002121:Calcium Channel Blockers; D016166:Free Radical Scavengers; D005782:Gels; D009821:Oils; C575034:emu Oil; D009529:Nicardipine; D013482:Superoxide Dismutase