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Hybrid Medical™ H100™ Peyronie’s Disease Treatment Delivers Hope

IRB Clinical Trial – Topical H100™ Peyronie’s Disease Treatment Shows Statistically Significant Improvement in Penile Length, Curvature and Pain1.

Hybrid Medical is proud to offer H100, a breakthrough Peyronie’s disease treatment option shown to relieve suffering for a majority of patients.   H100, is a patented and proprietary compound that combines an effective carrier agent with two plaque modifying ingredients.  In a randomized, prospective, placebo-controlled, double-blind IRB approved clinical trial with acute phase patients1,  this combination showed statistically significant improvement in penile length, curvature and pain.

 

After nearly a decade of research, Hybrid Medical developed a Peyronie’s disease treatment that should target inflammation, scar tissue remodeling, and plaque development.  As documented in prior independent studies, Nicardipine and Superoxide dismutase can accomplish this2,3.  To make sure these ingredients are delivered deep within the tissue, not just on the surface, we combined these ingredients with ultra-purified emu oil.  It contains the fatty acids necessary to be an effective carrier agent4,5,6. Emu oil also has been used for centuries by the Aborigines for scar tissue remodeling.

To verify that our scientific research was accurate, we performed a proof of concept/safety study that was double blind, randomized, and placebo-controlled.  The results were very positive with statistical improvement in penile curvature, stretched penile length and pain reduction.  Rash was the only side effect in about 10% of patients.

 Hear Dr. Twidwell discuss H100 research, ingredients and intended users.

Our initial study size was relatively small, but its design was done under the guidance of Dr. Larry Levine, a world expert in Peyronie’s disease.  Due to H100’s mechanism of action, the study only included acute phase patients with developing disease.

Abstract of Our Published Clinical Study Results

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

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

Twidwell J, Levine L.

Abstract

Safety and efficacy of topically applied gel H100 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 H100 and 11 patients received placebo for 3 months. All 22 patients then received H100 for the final 3 months. Flaccid-stretched penile length, degree of penile curvature, pain level and side effects were assessed monthly. H100 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 H100 is a safe and possibly effective non-invasive, topically applied treatment for acute phase Peyronie’s Disease.

The study size was relatively small, but its design was done under the guidance of Dr. Larry Levine, a world expert in Peyronie’s Disease.  Due to H100’s mechanism of action, the study only included acute phase patients with developing disease.

Based on our study, maximum benefit was seen after six months of treatment with H100, though many patients noted improvement after three months of treatment. (1)

A skin rash in the area of application is the only known side effect or adverse reaction in about 10% of patients with H100 use.

  1. J Twidwell, L Levine. 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 (2016) 28, 41–45; doi:10.1038/ijir.2015.22.
  2. 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: 3743–3749.
  3. Riedl C, Sternig P, Galle G, Langmann F, Vcelar B, Vorauer K et al. Liposomal recombinant human superoxide dismutase for the treatment of Peyronie’s disease: a randomized placebo-controlled double-blind prospective clinical study. Eur Urol 2005; 48: 656–661.
  4. Zemtsov A, Gaddis M, Montalvo-Lugo V. Moisturizing and Cosmetic Properties of Emu Oil: A Double Blind Study. Australas J Dermatol 1996; 37: 159–161.
  5. Qiu XW, Wang JH, Fang XW, Gong ZY, Li ZQ, Yi ZH. Anti-inflammatory activity and healing-promoting effects of topical application of emu oil on wound in scalded rats. [Article in Chinese]. Di Yi Jun Yi Da Xue Xue Bao 2005; 25: 407–410.
  6. Yoganathan S, Nicolosi R, Wilson T, Handelman G, Scollin P, Tao R et al. Antagonism of croton oil inflammation by topical emu oil in CD-1 mice. Lipids 2003; 38: 603–607.