Topical treatment for acute phase Peyronie's disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study

Int J Impot Res. Mar-Apr 2016;28(2):41-5. doi: 10.1038/ijir.2015.22. Epub 2015 Dec 24.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Calcium Channel Blockers / administration & dosage*
  • Free Radical Scavengers / administration & dosage*
  • Gels
  • Humans
  • Male
  • Nicardipine / administration & dosage*
  • Oils
  • Penile Induration / drug therapy*
  • Pilot Projects
  • Prospective Studies
  • Superoxide Dismutase / administration & dosage*

Substances

  • Calcium Channel Blockers
  • Free Radical Scavengers
  • Gels
  • Oils
  • emu Oil
  • Nicardipine
  • Superoxide Dismutase