Italian Hair Loss Lotion To Hit The Market In 2016

d3nt3dsh0v3l

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Hey guys, long time lurker and first time poster reporting in. I'm just gonna leave this here. Can anyone tell me if this is normal or bad news?
 

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MomoGee

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Hey guys, long time lurker and first time poster reporting in. I'm just gonna leave this here. Can anyone tell me if this is normal or bad news?
Don't worry I am in Europe and can definitely open an Ebay store if you guys need it to be sent to the US. I won't even add a profit margin.
 

MrJolly16

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Ok, so if they have hired someone to translate news into German what can we guess from that? At least we know they care about the lotion, because they are trying to reach more attention. Sounds crazy, but I think they will publish more news sooner than we think.
 

MrJolly16

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Sorry guys, but was that the original Italian news?

10/01/2017
Studio inerente l'alopecia
Aggiornamento da Fidia Farmaceutici
A seguito della nostra precedente comunicazione, relativa alla sperimentazione condotta da Fidia Farmaceutici a partire dalla scorsa primavera, ci preme comunicare che non sono ancora stati completati gli studi ed ottenuti i relativi risultati, in grado di consentire la commercializzazione del prodotto.

Come sempre sottolineato e ribadito, essendo Fidia un’azienda farmaceutica, tutto ciò che facciamo e sviluppiamo, deve essere testato e deve anche assicurare un’adesione a parametri di qualità.

Questo a dimostrazione della serietà dell’azienda, pur cosciente dell’entità del problema, tuttora irrisolto, che affligge un numero elevato di persone di varia età, non solo in Italia ma anche all’estero come testimoniato dalle migliaia di mail e telefonate ricevute nel corso dell’anno.

Riconoscendo che si tratta di una patologia invalidante e psicologicamente impattante, a tutela dei pazienti che ne sono affetti, Fidia si impegnerà a perseguire tutte le strade possibili per rendere disponibile un prodotto efficace, sicuro e stabile, al termine dei necessari studi richiesti.

Al fine di soddisfare quanto sopra, stimiamo che lo sviluppo durerà fino al 2018.

http://www.fidiapharma.com/it/news-eventi/studio-inerente-l-alopecia,3,116
 

Afro_Vacancy

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Sorry guys, but was that the original Italian news?

10/01/2017
Studio inerente l'alopecia
Aggiornamento da Fidia Farmaceutici
A seguito della nostra precedente comunicazione, relativa alla sperimentazione condotta da Fidia Farmaceutici a partire dalla scorsa primavera, ci preme comunicare che non sono ancora stati completati gli studi ed ottenuti i relativi risultati, in grado di consentire la commercializzazione del prodotto.

Come sempre sottolineato e ribadito, essendo Fidia un’azienda farmaceutica, tutto ciò che facciamo e sviluppiamo, deve essere testato e deve anche assicurare un’adesione a parametri di qualità.

Questo a dimostrazione della serietà dell’azienda, pur cosciente dell’entità del problema, tuttora irrisolto, che affligge un numero elevato di persone di varia età, non solo in Italia ma anche all’estero come testimoniato dalle migliaia di mail e telefonate ricevute nel corso dell’anno.

Riconoscendo che si tratta di una patologia invalidante e psicologicamente impattante, a tutela dei pazienti che ne sono affetti, Fidia si impegnerà a perseguire tutte le strade possibili per rendere disponibile un prodotto efficace, sicuro e stabile, al termine dei necessari studi richiesti.

Al fine di soddisfare quanto sopra, stimiamo che lo sviluppo durerà fino al 2018.

http://www.fidiapharma.com/it/news-eventi/studio-inerente-l-alopecia,3,116

@Dante92 @Guzam is this a good translation?

Following our previous report on the experiment conducted by Fidia Farmaceutici since last spring, we want to communicate that are not yet completed his studies and obtained the results, able to allow the marketing of the product.

As always he underlined and reiterated, being a pharmaceutical company Fidia, everything we do and develop, must be tested and must also ensure adherence to quality parameters.

This demonstrates the seriousness of the company, although aware the extent of the problem, as yet unresolved, affecting a large number of people of various ages, not only in Italy but also abroad, as evidenced by the thousands of emails and phone calls received in year.

Recognizing that it is a debilitating disease and psychologically impactful in the protection of patients who are affected, Fidia is committed to pursue all possible avenues to make available an efficient, safe and stable, once the necessary studies required.

In order to meet the above, we estimate that growth will last until 2018.
 

d3nt3dsh0v3l

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I wonder if this has anything to do with why Fidia has no plans to release the lotion in the U.S.
Compositions and products containing S-equol, and methods for their making
My account is too young and annoyingly, I can't seem to post links yet. Sorry guys. It's this one:
US7396855B2

And also US20060122262A1 goes into a lot more detail about DHT-related uses.

 
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Pacey123

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livinginfear93

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Does anyone have a link to anything that provides any hope this actually works on male hairloss or is it just speculation on Dr. Brotzu's part? Not antagonizing, it's just that I'm having trouble between the 400 pages to sift through and the foreign languages haha
 

Afro_Vacancy

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Does anyone have a link to anything that provides any hope this actually works on male hairloss or is it just speculation on Dr. Brotzu's part? Not antagonizing, it's just that I'm having trouble between the 400 pages to sift through and the foreign languages haha

Fidia is following standard legal protocol. They say that they're investigating the issue with trials. They make no promises as to efficacy.

So equol however has a strong theoretical basis.
 
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Trouse

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I'll wire money and have one of you euros ship it to me in the states. I trust you guys.



(...I think)
 

champpy

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I can't imagine that if this product actually works they won't try everything in their power to get this to be sold in one of the biggest markets in the world.
 

d3nt3dsh0v3l

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Does anyone have a link to anything that provides any hope this actually works on male hairloss or is it just speculation on Dr. Brotzu's part? Not antagonizing, it's just that I'm having trouble between the 400 pages to sift through and the foreign languages haha

It’s speculation in that no data have been released for the use of the lotion or really any of the lotion’s components for the treatment of androgenetic alopecia. All we have is the good professor’s word that he did in fact try it on balding men and that it worked.


The lotion makes a fair amount of sense based on what we know.

Brief history from [Male Alopecia: Guide to successful management; Ralph M. Trüeb, Won-Soo Lee]

~400 B.C.: Hippocrates noted that Eunuchs do not go bald.

~350 B.C.: Aristotle noted that male sexual maturation was a prerequisite for male pattern baldness.

It was suspected that whatever makes a man “male” is implicated in hairloss.

1942: Dr. James B. Hamilton shows that Androgenetic Alopecia can be triggered in men castrated prior to puberty if they were injected with testosterone.

Androgens were implicated in hairloss.

1974: Imperato-McGinley et. Al. observed intersex children in the Carribean who appeared sexually ambiguous at birth, but then grew external male genitalia and other masculine characteristics after the onset of puberty. These patients had a genetic mutation that made them deficient in 5-α reductase, which is responsible for the conversion of testosterone to dihydrotestosterone. As adults, these patients had underdeveloped prostates and also no incidence of male pattern baldness.

DHT was implicated in hairloss.

1990: Merck develops finasteride, a potent, competitive suicide inhibitor of 5-α reductase isoenzymes type II and III.

1998: 1mg finasteride tablets became the second FDA-approved prescription drug for the treatment of male pattern baldness.

· The inhibition of DHT’s actions on the hair follicle, or perhaps that of a step further downstream of this hormonal process, is a necessary step to halt hairloss.

2003: Propecia Help was formed. Many men reported transient, temporary (while on the drug) as well as permanent side effects from finasteride. Side effects included loss of libido, inability to concentrate, anxiety, suicidal thoughts/depression, poor sperm quality, erectile dysfunction, etc.


Large scale studies do not report a significant incidence of sexual side effects in finasteride users, both for hairloss as well as for BPH.

[Risk of erectile dysfunction associated with use of 5-α reductase inhibitors for benign prostatic hyperplasia or alopecia: population based studies using the Clinical Practice Research Datalink; Katrina Wilcox Hagberg,1 Hozefa A Divan,2 Rebecca Persson,1 J Curtis Nickel,3 Susan S Jick ]


It is also speculated that erection difficulty and depression could stem from the accidental inhibition of neurosteroids also synthesized via 5-α reductase, the most often cited of which is allo-pregnanolone.

[Finasteride, a 5a-Reductase Inhibitor, Blocks the Anticonvulsant Activity of Progesterone in Mice; TUSHAR G. KOKATE, MELISSA K. BANKS, TAMIKA MAGEE, SHUN-ICHI YAMAGUCHI and MICHAEL A. ROGAWSKI]

~2007: There is growing interest in being able to deliver finasteride topically in order to avoid possible systemic side effects due to prolonged androgen/5-αR deprivation.

[Development of Liposomal Systems of Finasteride for Topical Applications: Design, Characterization, and In Vitro EvaluationDevelopment of Liposomal Systems of Finasteride for Topical Applications; Rajiv Kumar, Bhupinder Singh, Gautam Bakshi, and Om Prakash Katare]

[A novel finasteride 0.25% topical solution for androgenetic alopecia: pharmacokinetics and effects on plasma androgen levels in healthy male volunteers; Maurizio Caserini1, Milko Radicioni2, Chiara Leuratti2, Ottavia Annoni2, and Renata Palmieri]

[Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia; Maurizio Caserini1, Milko Radicioni2, Chiara Leuratti2, Emanuela Terragni2, Matilde Iorizzo3, and Renata Palmieri]

[Topical Formulations Containing Finasteride. Part I:In VitroPermeation/Penetration Study and In Vivo Pharmacokinetics in Hairless Rats; DANIELA MONTI,1SILVIA TAMPUCCI,1SUSI BURGALASSI,1PATRIZIA CHETONI,1CARLA LENZI,2ANDREA PIRONE,2FEDERICO MAILLAND]


[Topical Formulations Containing Finasteride. Part II: Determination of Finasteride Penetration into Hair Follicles using the Differential Stripping Technique; SILVIA TAMPUCCI,1SUSI BURGALASSI,1PATRIZIA CHETONI,1CARLA LENZI,2ANDREA PIRONE,2FEDERICO MAILLAND,3MAURIZIO CASERINI,3DANIELA MONTI]


To date, nobody has demonstrated a liposomal topical finasteride solution that maintains efficacy while allowing serum DHT to remain high. Some low-dose liposomal formulations resulted in an amount of finasteride in serum below the detection limit, but nevertheless, serum DHT inhibition was still ~70%. Finasteride is known to have a very steep dose-response and a tendency to accumulate in tissues.

· Nominally, DHT should be reduced locally in order to avoid interfering with the function of other organs, such as the prostate.



1988: Originally developed for hypertension, 2% Minoxidil is FDA approved for treating hairloss. Minoxidil is now thought to function as a potassium-channel opener. This is believe to result in opening of the blood vessels, improving circulation to the follicles and prolonging the duration of anagen.

· Improvement of microcirculation to the hair follicle can result in a significant increase in hair size and growth.


So we know that any good next-generation preventative regimen must address all three of the bullet points. Brotzu’s lotion appears to have a fantastic shot at doing all three.


· s-equol is known to selectively bind to 5-αDHT

but NOT to testosterone, dehydroepiandrosterone or estrogen with high affinity. S-equol also does not bind to the androgen receptor or 5-α reductase. Dr. Brotzu claims that adding s-equol to his formula improved its effectiveness by 80% (Don’t take that as a real number, it’s probably just a casual estimate).

[Equol: Pharmacokinetics and Biological Actions; 1,2KennethD.R.Setchell3*andCarloClerici4]

[Equol Is a Novel Anti-Androgen that Inhibits Prostate Growth and Hormone Feedback1; Trent D. Lund,2,3 Daniel J. Munson,3 Megan E. Haldy,3 Kenneth D.R. Setchell,4 Edwin D. Lephart,5 and Robert J. Handa3]

[Use of equol for treating androgen mediated diseases; Edwin Lephart Trent Lund Kenneth David Setchell Robert Handa US20060122262A1]



· Prostaglandin E1 is a very potent vasodilator.

but it has not been thoroughly investigated for the improvement of alopecia. Dr. Brotzu claims that a topical he made containing it grew hair as a side effect. Additionally, he claims that the precursor to PGE1, dihomo-γ-linoleic acid, works just as well.

[Prostaglandin-Induced Hair Growth; Murray A. Johnstone, MD,1and Daniel M. Albert, MD, MS]

[Prostaglandin E2: igniting the fire; Carlo Chizzolini and Nicolo`C Brembilla]



Sucks that the formulation is a bit of a leap of faith on several fronts. On the other hand, it is the culmination of several things that others are investigating also for the effects we desire in treatment and the idea behind the formulation is still consistent with what would be required for halting hairloss. Even if the lotion goes systemic despite the liposomes, it might be alright. Finasteride destroys the enzyme that catalyzes the conversion of testosterone to DHT. So once the catalyst is gone, no action can occur. This might be why the dose response is so unweildy. S-equol binds directly to DHT so at least one could expect the dose response to be more linear with regard to DHT inhibition. Additionally, s-equol is present in people already due to the presence of certain gut bacteria. Point is, if equol from the topical leeches into the body, it might be just fine. That alone is exciting to me. Brotzu claims DGLA/PGE1 is a better vasodialator than minoxidil in the oral presentations he gives, but I don't know much about that.
 
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d3nt3dsh0v3l

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If they do, it will take an absolute minimum of multiple years to achieve according to current regulations. People in the US are fucked though from what I can tell. You can still probably get someone to ship it to you, but it will be highly illegal if you're caught. I can't imagine that the chances of getting caught are high though if they manage to ship it without it a hassle, but I don't know how that sh*t works.

Ebay won't let you sell it unless you intentionally try to deceive and list the product as something it isn't. I'm really not seeing a legitimate workaround. If someone does, feel free to chime in.

It's too soon to worry so much about this, firstly.

Next...breh, people use "online pharmacies" all the time to get random prescription stuff without prescription and don't seem to gaf. Occasionally, customs seizes a package and people just seem to accept the loss and try again.

Case in point: tretinoin cream is popular among acne sufferers and anti-aging fanatics. In America, you need a prescription for the stronger stuff and it gets expensive. In some European countries, it is dirt cheap and over the counter. People just order it. Yolo. There are hundreds on forums using tretinoin alone.

Of course, I would never condone illegal actions but...the thug life is an alternative that many people choose to take everyday ;)
 
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