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Transdermal application of H100 gel to the penile shaft in patients with Peyronie’s disease infiltrates the tunica albuginea

International Journal of Impotence Research volume 36, pages 107–109 (2024)Cite this article

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Abstract

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. 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. Three 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). All three patients tolerated H100 gel application without side effects. All three tunica albuginea specimens showed detectable nicardipine in the tunical tissue. 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.

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References

  1. Dibenedetti D, Nguyen D, Zografos L, Ziemiecki R, Zhou X. A population-based study of Peyronie’s disease: prevalence and treatment patterns in the United States. Adv Urol. 2011;2011:282503.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Barrett-Harlow B, Wang R. Oral therapy for Peyronie’s disease, does it work? Transl Androl Urol. 2016;5:296–302.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, et al. Outcomes of a novel penile traction device in men with Peyronie’s disease: a randomized, single-blind, controlled trial. J Urol. 2019;202:599–610.

    Article  PubMed  Google Scholar 

  4. Levine L, Newell M, Taylor F. Penile traction therapy for treatment of Peyronie’s disease: a single-center pilot study. J Sex Med. 2008;5:1468–73.

    Article  PubMed  Google Scholar 

  5. Martin D, Badwan K, Parker M, Mulhall J. Transdermal application of verapamil gel to the penile shaft fails to infiltrate the tunica albuginea. J Urol. 2002;168:2483–5.

    Article  CAS  PubMed  Google Scholar 

  6. Levine L, Goldman K, Greenfield J. Experience with intraplaque injection of verapamil for Peyronie’s disease. J Urol. 2002;168:621–6.

    Article  CAS  PubMed  Google Scholar 

  7. Soh J, Kawauchi A, Kanemitsu N, Naya Y, Ochial A, Naltoh Y, et al. Nicardipine vs saline injection as treatment for Peyronie’s disease: a prospective, randomized, single-blind study. J Sex Med. 2010;7:3743–9.

    Article  CAS  PubMed  Google Scholar 

  8. Gelbard M, Goldstein I, Hellstrom W, McMahon C, Smith T, Tursi J, et al. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of Peyronie’s disease in 2 large double-blind, randomized, placebo-controlled phase 3 studies. J Urol. 2013;190:199–207.

    Article  CAS  PubMed  Google Scholar 

  9. Twidwell J, Levine L. 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. 2016;28:41–45.

    Article  CAS  PubMed  Google Scholar 

  10. Fitch W, Easterling W, Talbert R, Bordovsky M, Mosier M. Topical verapamil HCL, topical trifluoperazine, and topical magnesium sulfate for the treatment of Peyronie’s disease- a placebo—controlled pilot study. J Sex Med. 2007;4:477–84.

    Article  CAS  PubMed  Google Scholar 

  11. Zemtsov A, Gaddis M, Montalvo-Lugo V. Moisturizing and cosmetic properties of emu oil: a double-blind study. Aust J Dermatol. 1996;37:159–61.

    Article  CAS  Google Scholar 

  12. Qiu X, Wang J, Fang X, Gong Z, Li Z, Yi Z. Anti-inflammatory activity and healing-promoting effects of topical application of emu oil on wound in scaled rats. Di Yi Jun Yi Da Xue Xue Bao. 2005;25:407–10.

    PubMed  Google Scholar 

  13. Kouoh F, Gressier B, Dine T, Luyckx M, Brunet C, Ballester L, et al. Antioxidant effects and anti-elastase activity of the calcium antagonist nicardipine on activated human and rabbit neutrophils—a potential antiatherosclerotic property of calcium antagonists? Cardiovasc Drugs Ther. 2002;16:515–20.

    Article  CAS  PubMed  Google Scholar 

  14. Kinnula V, Crapo J. Superoxide dismutases in the lung and human lung diseases. Am J Respir Crit Care Med. 2003;167:1600–19.

    Article  PubMed  Google Scholar 

  15. Yamane N, Takami T, Tozuka Z, Sugiyama Y, Yamazaki A, Kumagai Y. Microdose clinical trial: quantitative determination of nicardipine and prediction of metabolites in human plasma. Drug Metab Pharmacokinet. 2009;24:389–403.

    Article  CAS  PubMed  Google Scholar 

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Authors and Affiliations

  1. Minnesota Urology, Minneapolis, MN, USA

    Jeffry Twidwell, Joseph Mahon & Dean Tortorelis

  2. Rush Medical College, Chicago, IL, USA

    Laurence Levine

Authors
  1. Jeffry Twidwell
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  2. Joseph Mahon
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  3. Dean Tortorelis
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  4. Laurence Levine
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Contributions

JT: study design, manuscript creation; JM: patient enrollment; DT: patient enrollment; LL: study design, manuscript review.

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Correspondence to Jeffry Twidwell.

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Competing interests

JT: Chairman Hybrid Medical, JM: compensated for study patient enrollment by Hybrid Medical, DT: compensated for study patient enrollment by Hybrid Medical, LL: compensated Medical Advisor, Hybrid Medical.

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Twidwell, J., Mahon, J., Tortorelis, D. et al. Transdermal application of H100 gel to the penile shaft in patients with Peyronie’s disease infiltrates the tunica albuginea. Int J Impot Res 36, 107–109 (2024). https://doi.org/10.1038/s41443-023-00819-w

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