Polichem Topical Finasteride Phase 3 Results Out

Update: June 6, 2019

It seems like P-3074 will be called ALM12845 when finally released. Per Almirall’s first quarter 2019 filings:

“The top-line Phase III results for ALM12845 (androgenic alopecia) in the EU show statistical significance for the primary end-point (Change of Target Area Hair Count) at week 24. We expect the submission in Europe of ALM12845 in Q4 2019.”

My guess is that a “submission” in Europe means the same as in the US: i.e., the company is filing for approval to sell the new drug after successful Phase 3 trial completion.

Polichem Almirall

April 19, 2019

I have covered topical finasteride (see archives) on this blog numerous different times. This despite the fact that I am far more interested in topical dutasteride.

Polichem — Topical Finasteride Phase 3 Trial Results

Earlier today, Switzerland-based Polichem (now owned by Spain’s Almirall) finally released the results of its Phase 3 trials for its eagerly awaited P-3074 topical finasteride product. This came after many months of anticipation (h/t to the guy who e-mailed me this news).

Edit: It seems like they released results in the EU last month, in a slightly different format to the US ones from today. I never wrote about this important development last month.

From what I can tell, both oral finasteride (105 test patients) and topical finasteride (48 test patients) seem to have given almost the same  results in increase in hair growth after 24 weeks.

Side effects between oral and topical finasteride also seem similar, although they are based on surveys of the patients rather than any scientific methodology.

I suppose many volunteers would drop out if they were asked to come in every couple of months for testing of erectile strength, hormonal blood tests, sperm count and so on. As it is, even in these trials, around 30 percent of subjects dropped out before the 24 weeks were over.

Most studies from the past several decades suggest very limited potential for long-term side effects from oral finasteride. If you do not believe those studies, you could still try out topical finasteride (available at most local compounding pharmacies).

No idea if Polichem will commercialize P-3074.

94 thoughts on “Polichem Topical Finasteride Phase 3 Results Out”

    1. You might be right, maybe they published in EU first and now the US. Will check later to see if any changes between the two.

  1. They had the participants assess their own results using a ‘Overall Male Hair Growth Questionnaire Score’ rating:
    1 = Very Satisfied
    2 = Satisfied
    3 = Neutral
    4 = Dissatisfied
    5 = Very Dissatisfied

    The ratings were 2.9 (12 Weeks) and 2.8 (24 Weeks) which means they were only slightly above neutral. That makes me 4.2 : (

    1. I’ve been on empower pharmacy’s topical fin for 6 months I havent noticed really anything but also I do think its helping stop. I would absolutely rate 2.8. Maybe I’m using it too sparingly though who knows.

      1. Unfortunately for me, a neutral product isn’t going to move my 4.2 — and I’m talking about my Norwood number now : P

  2. These were already released a month ago. Same efficacy as finasteride but the whole point of this was to find out if it worked without having an effect on DHT levels, which they didnt measure..

  3. Gives those of us who aren’t getting side effects (or just don’t care like me) on oral finasteride the opportunity to add topical finasteride and perhaps obtain greater benefit.

  4. It’s so strange to me that we’ve had recent promising news yet no pictures. It’s like a 19th century newspaper where we have to use our imagination.

  5. Hard to believe they didn’t measure it, probably measured but didn’t publish.. Anyone knows when it is expected to be released?

  6. Do you think this will boost results if used in combination with oral fin? Also do you think that topical finasteride can be used to get rid of body hair?

  7. yeah a bit odd no hormone panels when its not that impossible to do since this format does not answer a lot about sides, but probably cheaper and easier to do.
    Given the large cost difference since oral is very cheap now I will stick to that, and risk the sides. Although every single person in oral fin is waiting for a safer alternative. its not for fun.
    Its just not convincing evidence that topical is safer than oral

  8. Disappointing that there were no DHT measurements (I guess that would add a lot to the cost for one thing), but the questionnaire about sexual function etc could be a useful proxy, especially comparing the left column (topical + placebo pill) vs right column (placebo topical + pill).

    I can’t do a sophisticated statistical analysis or understand theirs, but adding up the net difference in the results for each of the 5 categories gives a significant net win for topical in each question category except for sexual desire where the pill had a slight lead.

    I look forward to reading the published paper or at least its abstract in due course.

    1. I checked the phase 2 results, topical had 25% systemic dht reduction as compared to 55% in oral

      Still crap if u ask me, i thought it was gna b 5%!

  9. I really can’t believe that they are not testing the basic ? CHECK THE DHT LEVELS !!!!!!! that is all they have to check

  10. Not related to this post but contact form suggests I should post here anyway. I’ve been taking Pentoxifylline and have noticed that my morning hair loss has fallen pretty dramatically, from about 100 to 5. I don’t see any evidence of this effect on PubMed and it’s not commonly prescribed to young people. Reading about how it works, it seems like a plausibly interesting drug. I’m 3mo in and have another 3mo to go so I’m eager to see if this trend will continue.

    I’m wondering if admin may have heard other reports about it or can find any references I may have missed?

    1. Very interesting Adam. Pentoxifylline improves blood flow and is also an anti-inflammatory. Too bad that not many young people take this drug, or else we might have had more anecdotal evidence.

  11. Pessimism has got to play a role in those dropouts. If you’re part of a blind trial, and you’re getting no results — or at best marginal results — after a few months, many will think “I’m in the placebo group” and just wash out.

    I shit at math, but there are some very strange discrepancies, particularly in the difference between investigator/blind investigator results and in the self-reported results versus the target area hair counts. And the “treatment emergent adverse events” category seems seriously padded out to make the placebo group comparable to the topical drug group. Like, a nasal septum deviation — which is either congenital or due to physical trauma — is honestly considered to be a relevant comparison datum? Or “exposure via father” constitutes an adverse event for the placebo group?

    I’m really starting to distrust trial results. Too much seems designed to achieve the positive results the company wants.

    I guess I lost my optimism along with my hair.

  12. Hey Admin,

    I know they sell liquid solution Chitosan. I wonder if we can just compound this on our own through compounding pharmacies. What are your thoughts on this.

    1. Not to speak for the admin, but while chitosan may improve a drug’s skin permeability, it won’t affect the solubility. Finasteride is barely soluble in water. There’s no information about polichem’s vehicle, but their .25% solution is typical of what’s available from compounding pharmacies, and is usually about half ethanol and half aqueous solution. That seems to be the maximum solubility of finasteride in a skin-friendly solution, short of using pure ethanol. Drug delivery vehicles with chitosan usually consist of polymersomes produced with polyacrylates. There’s a lot more chemistry involved than simply mixing two solutions.

      The likely result of mixing an aqueous solution of chitosan into an ethanol/water vehicle containing finasteride would be that the finasteride would precipitate out.

      Even if you had a stable solution, I don’t know if chitosan would augment the finasteride penetration without a molecular association/complex like a liposome or polymersome.

      1. I use topical finasteride topical lisosomal gel 0.25%, prepared by farmacia parati. This, in addition to topical finasteride tablets. I usually offset them by alternating days. I do get sides from finasteride use so i supplement with 200 mg daily of DIM which removes excess estrogen and significantly reduces side effects.

      2. Al’Opecia

        Articulated beautifully. My thought on the permeability aspect was to cause the solution to suspend in the scalp leaving more of a chance for the bulb to be reached but creating less of a chance of moving beyond a saturation point hence elevated serum dht. However you do make the good point that it most likely takes many steps to incorporate chitosan into this solution the proper way and that a lay person slapping it together would probably result in an incomplete solution.

        1. I had the same initial thought as you, hence the research. My topical-hacks have mostly been failures. Seems like chitosan is easy to use with hydrophilic compounds, but unfortunately finasteride and minoxidil are both fairly hydrophobic.

          There’s some interesting research about using cyclodextrins to make more concentrated finasteride solutions, and they also enhance drug penetration. They are safe and easy to use for hobbiest chemists, too. I haven’t done the math, though. Won’t experiment with finasteride anymore in home with young son.

          https://www.ncbi.nlm.nih.gov/pubmed/28652706

          1. Al O’Pecia, you may be interested in this study, which seems to be by Polichem (uses the same ethanol-PG-water vehicle ratios as polichem’s patent), into absorbtion of topical finasteride in conjunction with chitosan. From my notes (I read this a long time ago), Part II shows 20% increased fin in the follicle layer at 24hrs and faster permeation with chitosan than without, so seems like a small but significant advantage.

            https://www.researchgate.net/publication/263015001_Topical_Formulations_Containing_Finasteride_Part_II_Determination_of_Finasteride_Penetration_into_Hair_Follicles_using_the_Differential_Stripping_Technique

            1. Very interesting. Can’t tell from much from abstract about the production/composition of the vehicle, but sounds promising. Thanks Greg!

              These novel vehicles for topical delivery of difficult molecules are an important element in the search for viable, non-surgical treatments for hairloss. We have some “effective” topicals on the market, but these ethanol/polyol vehicles suck. And I’m worried that even with new promising topicals in the pipeline, significant results will depend on stacking marginally effective drugs. We can’t just stick them all in a blender, but how many applications of greasy crap can we handle? The development of new, non-irritating vehicles that can deliver multiple drugs in a single topical with adequate penetration may be just as important as the development of new compounds. I don’t think the potential of minoxidil and finasteride have been exhausted, either.

              I guess I’d settle for greasy, matted, funky hair, so long as there IS hair.

      1. I got an Exosomes + PRP Treatment, the former is more powerful.

        Basically these are cord-blood derived stem cells but they’re smaller and can get into your hair follicles better than regular cord blood stem cells.

        These kinds of stem cells are used to treat shoulder pain, joint pain, knee pain, cancer, etc. They’ve recently started being used for cosmetic purposes: stem cell therapy for hair loss. The hierarchy goes like this:

        1. PRP (Weakest)

        2. ACell + PRP

        3. Stem cell therapy (exosomes) + PRP (Most effective)

        Adiospse (fat derived) stem cells are also used for this but the technology is older and less effective.

        The procedure is a bunch of injections into your balding areas (kind of like RCH-01). Although it does not create new hairs, it rejuvenates old ones and forms new baby hairs; the more hairs you have at baseline, the better.

        This treatment also rules out minoxidil, laser caps, dermarolling, (which was part of the procedure I got), and even the infamous finasteride. The results are the same and even better than finasteride if you’re still a NW3 or less; this is the people I’d recommend this treatment to.

        So what’s the catch? Better than finasteride and you can drop all your other meds? (Which isn’t what I’ve done) PRICE. The cost of this procedure is comparable to that of a premium hair transplant. (4K-5K). And you have to get it done every few moths to get better and better results for one year, and then once every year after for maintenance. But in a year or two, Shiseido or Tsuji will already be out. So you can decide if it’s worth spending high four or low five figures before then. Success rate is over 90 percent. Hope this helps.

        If you’d like to look into this procedure, search up “stem cell therapy for hair loss”. Ask about exosomes or if they just do coed blood stem cells. Make sure to pick a nice clinic. A lot of scammers out there so be careful.

  13. I hate saying this but topical fin doesn’t hold a candle to oral fin. I’ve done both and I can’t say topical even works.. I wish it did so bad butit didn’t for me when oral did.

    Follica tsuji shiseido is our only arm length treatments here

  14. Admin, Um…WHY IS SOMEONE IMPERSONATING ME?!

    These are NOT my comments:

    “Disappointing that there were no DHT measurements (I guess that would add a lot to the cost for one thing), but the questionnaire about sexual function etc could be a useful proxy, especially comparing the left column (topical + placebo pill) vs right column (placebo topical + pill).

    I can’t do a sophisticated statistical analysis or understand theirs, but adding up the net difference in the results for each of the 5 categories gives a significant net win for topical in each question category except for sexual desire where the pill had a slight lead.

    I look forward to reading the published paper or at least its abstract in due course.”

    “Al O’Pecia, you may be interested in this study, which seems to be by Polichem (uses the same ethanol-PG-water vehicle ratios as polichem’s patent), into absorbtion of topical finasteride in conjunction with chitosan. From my notes (I read this a long time ago), Part II shows 20% increased fin in the follicle layer at 24hrs and faster permeation with chitosan than without, so seems like a small but significant advantage.

    https://www.researchgate.net/publication/263015001_Topical_Formulations_Containing_Finasteride_Part_II_Determination_of_Finasteride_Penetration_into_Hair_Follicles_using_the_Differential_Stripping_Technique

    “Further to my previous comment, similar results in vivo with rats using chitosan and topical fin
    https://www.researchgate.net/publication/263293187_Topical_Formulations_Containing_Finasteride_Part_I_In_Vitro_PermeationPenetration_Study_and_In_Vivo_Pharmacokinetics_in_Hairless_Rat

    WHOEVER IS IMPERSONATING ME, PLEASE STOP. IF you’re name is also “GREG”, please change it to Greg_1 or something of that nature. Your comments are helpful but I’d like the community to know that it’s not the original Greg posting them but someone else.

    Thank you.

    Btw, interesting post. Let’s wait for more info in a few weeks.

      1. No problem, GregB. Thanks for changing for name. Sorry for such an explosive reaction. I’m pretty territorial ;)

    1. The worst thing with topicals is that they are difficult to apply and you have to be very meticulous and consistent to use them rightly.Probably that is why minixidil does not work for many.

  15. Good News. Dr Neal Walker of Aclaris at a Jeffries Global Healthcare Conference told company will report ATI-502 trial results in the coming weeks.

        1. No Greg, I was just having a bit of fun with the previous comment by Rud and NASA’s unbridled optimism with JAK. :-)

    1. Pharmacological inhibition of overactive TRPV3 by forsythoside B can reverse hair loss

      Forsythoside B can reverse Hair loss so ? (not carvacrol)

  16. Aclaris should be releasing their Phase II results for JAK topical for AGA. We should know within the next two months, as they have over 30 very bald test subjects under study since early May 2018 for the early test subjects (from memory). They stated the results would be released early summer time 2019. All my opinion.

    1. Let this be OVER with where we just get a prescription for JAK Topical lotion and get all our hair back. D-Day is almost here for us.

      1. @nasa_rs I agree. A lot of news has come out about the highly tracked hair loss treatments and only more will be coming. Judging from the picture, the emerging industry seems further along today than it was a few years ago. Let’s wait for those results on the trial in a few weeks. JAK inhibitors are quite interesting and more advanced, from a technological standpoint, and will make good competition for other topicals.

      2. By strange coincidence this is also roughly the time when Shiseido will be releasing their RCH-01 results.

        We have a saying in England. You wait half an hour for a bus to turn up, then two turn up at the same time!

        Either cure is fine for me.

        1. @Scott Witty saying! I love English humor / culture. It’s also true though. The results for Shiseido release in July and the results for this treatment release in the coming weeks. I guess these companies have the same agendas.

  17. Aclaris just presented at some conference on 6/6/2019 and stated in one of their slides that they have 12 active clinical trials. Well, I looked at their Pipeline and I did count 12 Clinical Trials that means they are still ACTIVE in their JAK for AGA Trial. Remember, they used very bald people for their study thus it will be interesting to see what results they and they must be getting some type of result after all this time and the fact that they still show it as a clinical trial. There is hope. And soon enough, within two months, they should state what the results are with photos.

  18. NASA it is our hope that they show photos. Seems to be a rarity these days…..and btw histogen has a new coo these days and from what I gather, they seem to be more interested in female hair loss. Boy have they been a let down.

  19. Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Week 24

    Vehicle: -1.5289 (0.36691)
    P-3074: -0.8052 (0.35151)
    Finasteride pill: 0.7163 (0.46679)

  20. I think jak and sisheido will have positive results but not what we all expect. I may sound pessimistic but I just don’t see a cure full blown regrowth from this. Something would have leaked by now if these treatments grew back massive thick dense hair. I’m going to guess that it will stop hair loss and regrow some density…IIke 15 to 30% best case scenario. Which is still good but not what nasa is expecting. A cure to me is thick dense regrowth where I can get it wet, gel it up and show no signs of diffusion or thinning. People see rivertown pics and are excited like it’s a cure. I see 4 new hairs on a old bald man. Cure is thrown around these forums like a midget in prison…

    1. the problem is that you guys aren’t realistic about this at all

      balding and losing hair is a part of aging dude

      nobody makes it to 80 with the exact same hair that they had when they were 16, even those who got blessed with 99.999 percentile hair genetics. If you’re in your 30’s, 40’s, 50’s etc. you shouldn’t expect to have perfect, untouched hair. what some of you guys are expecting/wanting is basically a minor cure for reversing aging, which is a pipe dream and not at all a part of the human experience.

      temper your expectations and life will be much, much better for you bruh

      1. Part of aging? Do you realize that there are dudes under 30 with nw7 hairlines?

        Hair cloning will be the pipe dream, I don’t expect a “real cure” from any other treatment.

  21. Wanted to do a small pole here. Which are you guys looking forward to more?

    1. New topicals

    2. New cell-based therapies

    Please share your thoughts

    1. — Topicals if I’m poor. — Cell-based if I hit the jackpot.

      Topicals feel like running downhill in that I’m constantly being pulled by a momentum which will collapse at the slightest misstep, whereas a cell-based would give me a few years or even decades of hairline and mental stability. I would no longer be daily occupied with needles and droppers and formulas and concealers and hats and buzzers and razors and could better focus my time on all my other inadequacies.

      I like to believe it will be possible to go into a Tsuji clinic, pay tens of thousands, and grow out a full head of thick, natural hair that will never ever diminish—well, that’s my dream!

      1. @Toccata That’s what they mean by working on the cure. Crazy to believe that something like that will become reality shortly. Though it’ll only be in Japan for the first years after launch it’ll still be there. Hopefully 2021 will be the year for tsuji, since their trial’s starting next year, and 2020 will be the year for Shiseido, if not later this year – TBD. But yeah. Our years of worry are coming to an end for good, *if we have the money. And even if we don’t, those new topicals will probably be pretty effective as well.

          1. @D1 It looks like topicals will be about a couple years from 2020. Multiple forums and separate sources believe Breezula will be out in 2022. I don’t know why they’re so fixed on that date but that’s when it could come out. Probably the FDA and other countries’ equivalents that are holding these drugs from releasing. Not too sure about JAK inhibitors topicals; i guess around the same time, plus or minus a year.

            Legislation is a big factor. A lot of these new products are certainly better than minox (except brotzu lotion), but that’s not a far bar to pass but minox is a huge industry. Same with finasteride.

            Those same forums and individual commentators believe that cell therapies (in Japan) will be available more readily for the same reason topicals won’t be; a different approach in legislation.

            1. Samumed finish their phase 3 trials by October 2020, so I guess earliest is 6 months after that?

              Breezula are only doing 6 month phase 3 trials (and their phase 2 was enormous). Surely as they finish before Q2 2020 they could have a product out for the start of 2021/end of 2020?

              Another popular hairloss site puts Follicum out in 2020/21 but I cannot see how this is.

              No idea about Histogen.

              I thought there was talk the JAK inhibitors could be fast tracked through the drug process due to already having passed safety tests? Could this speed things up?

              Follica is only cheaper option coming out soon I think.

          2. None by 2020 put simply, except this topical fin from Almiral/Polichem

            2022 is Breezula (from their website), Samumed and Folicum..If all goes to plan should be a good year for hairloss!

            Also left-field but Rivertown is slated for then but not as sure

        1. nothing will come out shortly, come on let’s be honest, it’s nice to dream and all… but that would be somenthing bigger than life right now, yes that’s right, bigger than life. Just imagine the impact on society, mass media and all… it’s like as if someone suddenly would say… hello everybody we’ve just discover a pill that makes you 30 years younger LOL… it ain’t goona happen, at least not now.
          Sorry dudes

  22. Its almost 2020 and there is no cure this sucks , I want to share my story with you I am 26 years man from Jordan , I started balding when I was just 15 years old , the barber told my father that your son is balding , I was so young that I didn’t understand what’s balding , my hair started thinning more and more and at age 16 it’s stopped thinning and till now (10 years later) I have the same amount of hair with slight improvement (nw 2.5) , can someone help me to understand this , it’s supposed that the earlier you bald the more aggressive the mpb , I went to a dermatologist 6 years ago and he told me I have male pattern baldness , my hairline is intact but I have small bald spot on vertex , how can this happen ??! And i don’t take any medication.

  23. Nick mpb isn’t due to aging. Fo above started balding at 15. I am in my mid 30s and half my friends have thick full hair while the other half are nw5. It’s all genetic. When you hit 50, 60s and up is when it’s due to aging not at 19 when it started for me.

    Fo hop on Propecia to save your hair. Something better will most likely come on in a couple years but in the meantime hop on Propecia to save what you have.

    1. Thank you for your reply , I am considering propecia seriously now , but how come my mpb has stopped for 10 years ? That was my question . Why start propecia if my mpb has stopped by its own , your opinion is really important to me , thank you

  24. Fo, some people lose hair for 3 years then it stops for a few years then starts to lose hair again. You also may have a thyroid issue that is causing hair loss and not mpb. I do find it strange that you started losing at 15 yrs old. You have another condition. The hairs you lose, are they shorter and thinner than the rest of your hairs? Check your vitamin and mineral levels, blood work to see if you have another issue. Hopefully your hair doesn’t thin out more and you got lucky:)

  25. Question for admin, Do you know whatever happened to dutasteride? I remember reading a long time ago that they were working on it. Is this still ongoing?

    1. @ Alexis JW Pharma planned to release Dutasteride tablets to market worldwide this year.
      (They also work on Topical Cosmetics against Androgenetic Alopecia which could come soon and also Research on a new drug CWL08006 for WNT signaling pathway together with UPen)

      1. Hey Admin, I actually saw a dermatologist offer topical dutasteride. Ill try and find the link for you. It was a product from the 82M minox line. I think it was called 82D.

        1. Hi Mjones, most local compounding pharmacies will offer to make it if you ask. Not cheap. A few hair transplant surgeons also offer it, usually only to their patients.

  26. Nasa what about Aclaris pictures in 2 months?
    Shseido waited a full year and a half to release it results if they have any if they release next month.

    Jak pics would be awesome but their going to run us into 3 more years of phase 2b phase 3 phase3b phase 4a etc etc. It could be 2022 by the time its on shelves

    1. @Egghead 2022 ain’t bad considering the market for topicals hasn’t changed in over 20 years. And the drug industry will soon be rivaled by the cell therapy industry too.

    2. We will not know until we know. Aclaris started the trails in May (or april) of last year and stated they would have news by early summer with photos if it worked.

      Its big news that they are still doing the trail after all this time and did not quickly stop it thus they must be getting some type of result and that in itself could be groundbreaking. But on the downside they did call the experiment with 30 people Exploratory thus it does seem as if it we would wait years more for an actual product. But first things first we need to know IF it does work then how well, with photos and that should be coming within months. I realize things drag out but they have been in trial for a year thus results should be coming soon as they stated. We will know what we know within a few short months.

    3. If its a year or five years it really does not matter. All that matters is IF they have an absolute treatment for close to 100% hair regrowth then we can plan our lives.

      The Aclaris news is going to End or Send All Of This Back to The Beginning for hair regrowth. And its all expected very shortly.

      1. @nasa_rs I agree. A few years really doesn’t make that big a difference, especially if we’re not talking about cell therapies but topicals. A few companies are releasing their trial results in the next couple of months so it should be an informing time.

  27. WHY nobody ask for systemic DHT lab test !? Is not the main reason of this topical ?! this should post the DHT levels before and after.

    1. P-3074 DHT tests were done in Phase II, so we’re aware of the reduction %.

      The problem I see with this treatment is, the target area hair width continues to decrease, despite the number of hairs increasing. So the increase appears to be vellus hair. IOW, there’s a correlation between the amount of the drug in your system and the efficacy of the treatment.

  28. I’m getting a hair system. My recent FUE procedure seems to be failing. I’m done waiting, I need a full-out cure, or nothing. Going with hair system.

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