H100 PD Treatment Breakthrough

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H100 Peyronie’s Disease Treatment Breakthrough

IRB Clinical Trial – Topical H100™ Peyronie’s Disease Treatment Shows Statistically Significant Improvement in Penile Length, Curvature and Pain. 1

Topically applied (not injected) H100 is most effective when used in the Acute phase of the disease, though it can be utilized in all stages. It is based on Hybrid Medical’s advancement in sub-dermal treatment delivery.  After a decade of research, we developed a Peyronie’s disease treatment that is intended to target inflammation, scar tissue remodeling, and plaque development.

A proprietary and patented combination of plaque-modifying ingredients and an effective transdermal carrier delivers medicine directly into the area of scar tissue. Research shows the ingredients disrupt the inflammatory process and remodel scar tissue which may reduce curvature and pain1. As documented in prior independent studies, Nicardipine and Superoxide dismutase can accomplish this5,6. We combined these ingredients with ultra-purified emu oil which contains the fatty acids necessary to be an effective carrier agent2,3,4.

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Emu oil

  • Oil from the emu bird native to Australia
  • Historically used by Aborigines to treat burns, wounds and scar tissue
  • Shown to be an extremely effective transdermal carrier2
  • May have anti-inflammatory and scar remodeling properties3,4
green health

Nicardipine

  • Shown to be clinically effective when injected into Peyronie’s disease tissue5
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Superoxide Dismutase (SOD)

  • Used to treat inflammatory and other diseases
  • Topically applied SOD has been shown to be effective in Peyronie’s disease studies6

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

 

How to Properly Apply H100

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.

No compounded medication is reviewed by the FDA for safety and efficacy.

Important Note:  H100 gel is only meant to be applied topically as directed for treatment of Peyronie’s disease. It is not intended for any other use. Do NOT take it orally, by injection or through any other method of delivery.  For best results, always follow prescribing directions carefully.

  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. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

Abstract of Our Published H100 Tissue Penetration Study

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

 

JEFFRY TWIDWELL, Minnesota Urology, Minneapolis , MN USA, JOSEPH MAHON, Minnesota Urology, Minneapolis , MN USA, DEAN TORTORELIS, Minnesota Urology, Minneapolis , MN USA, LAURENCE LEVINE, Rush Medical College, Chicago, IL USA

 

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. 

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). 

All 3 patients tolerated H100 gel application without side effects. All 3 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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