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

International Journal of Impotence Research volume 28, pages 41–45 (2016)Cite this article

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A Correction to this article was published on 02 June 2020

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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.

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Acknowledgements

We thank Harold Hoium, MBA, for contributions to study design, IRB compliance, ClinicalTrials.gov registration, coordination of drug development, database development, statistical analysis and statistics write-up. Statistical analysis was completed using standard features in Microsoft Excel.

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  1. Urology Associates, Robbinsdale, MN, USA

    J Twidwell

  2. Rush Medical College, Chicago, IL, USA

    L Levine

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  1. J Twidwell
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Correspondence to J Twidwell.

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Supplementary Information accompanies the paper on International Journal of Impotence Research website

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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 28, 41–45 (2016). https://doi.org/10.1038/ijir.2015.22

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