(145) TRANSDERMAL APPLICATION OF H100™ GEL TO THE PENILE SHAFT IN PATIENTS WITH PEYRONIE’S DISEASE INFILTRATES THE TUNICA ALBUGINEA

Introduction

Noninvasive treatment options for Peyronie’s disease (PD) remain limited. Topical H100™ gel (Hybrid Medical, Edina, USA) which contains nicardipine, super oxide dismutase and emu oil showed safety and efficacy in a previous small double-blind, placebo- controlled pilot study.

Objective

The present study evaluates if topically applied H100™ gel applied to the penile shaft infiltrates the tunica albuginea. Nicardipine is a key active ingredient in H100™ and serves as a surrogate marker.

Methods

3 men already scheduled to undergo a planned surgical procedure for PD applied commercially available H100™ gel twice daily to the penile shaft for up to 30 days prior to the procedure. Tunica albuginea samples were obtained at surgery. Nicardipine evaluation was performed using isotope dilution technique via liquid- chromatograph-mass spectrometry (LCMS).

Results

All 3 patients tolerated H100™ gel application without side effects. All 3 tunica albuginea specimens showed detectable nicardipine in the tunica tissue.

Conclusions

Transdermal application of commercially available H100™ gel is able to penetrate the tunica albuginea tissue and is detectable in men with acute and chronic PD. This finding may support the encouraging results found in the prior H100™ pilot study.

Disclosure

Yes, this is sponsored by industry/sponsor: Hybrid Medical.

Clarification: Industry initiated, executed and funded study.

Any of the authors act as a consultant, employee or shareholder of an industry for: Hybrid Medical.