Topical treatment for acute phase Peyronie’s disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study
Authors: J Twidwell
L Levine
Journal: International Journal of Impotence Research (2016)
Discipline: CLINICAL MEDICINE
Keywords: Peyronie's disease; H-100; Nicardipine; superoxide dismutase; emu oil
Affiliations: Urology Associates, Robbinsdale, MN, USA., Rush Medical College, Chicago, IL, USA.

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 &lt;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. 

Retracted: No

PubPeer comments:
 Conflict of interest. The authors present a small RCT showing impressive improvements when treating Peyronieu2019s disease with a topical gel on emu oil basis. The authors declare no conflict of interest. The article has two main authors, J Twidwell and L Levine, and an acknowledgment author H Homium (u201ccontributions to study design, IRB compliance, ClinicalTrials.gov registration, coordination of drug development, database development, statistical analysis and statistics write-upu201d). u2022tH Homium and J Widwell are listed as inventors on a patent filed in 2012 on the ointment described in the article [1]. The patent is assigned to Hybrid Medical LCC. u2022tH Homium is the owner and CEO of Hybrid Medical. J Twidwell is chairmain of its board. L Levine is chief medical advisor [2] u2022tHybrid Medical owns a websites [3] that since at least since 2013 u201coffer hope for sufferers of Peyronieu2019s diseaseu201d [4]. u2022tHybrid Medical owns a website [5] that advertises and sells the H100 gell in 50 states. J Twidwell features on its home page in a video advertising the u201cpatented and proprietaryu201d gel by refering to the study in IJIR. The study is references on the same page (u201cIRB Clinical Trial - Topical H100 Peyronieu2019s Disease Treatment Shows Statistically Significant Improvement in Penile Length, Curvature and Painu201d). u2022tHybrid Medical is listed on the Gust funding platform touting a u201cstrong financial return potential in very large market ($37b-$113b) with very little competitionu201d, u201cThere is no dominant treatment and no dominant company in this market (one small competitor)u201d, and  Hybrid Medical profitable with only 0.1% capture of only the US market at the lowest prevalence (3%). u201c [2]. With patent and business pre-dating the publication of the trial by several years and clear economic activity the u2018no conflict of interestu2019 statement does not hold. All three authors had a vested financial interest in a positive outcome of the trial at the time of publication. [1] https: patents.google.com patent US9333242B2 en [2] https: gust.com companies hybrid_medical [3] http: hybridmedicalmn.com, see http: whois.domaintools.com hybridmedicalmn.com for registrant [4] https: web.archive.org web 20130415102438 http: www.hybridmedicalmn.com [5] https: hybridmedical.org , 
 Correction: https: www.nature.com articles s41443-020-0303-z ,