Follica Pivotal Trial in 2019, FDA Filing in 2020.

Update: November 25, 2019 — A few days ago, “Toccata” emailed me a pdf document in which one small part mentioned that Follica was going to use Minoxidil as the compound after the microneedling.

Apparently, this document was also posted on several hair loss forums. However, no-one initially saw the page 46 small Minoxidil part except “Toccata” as far as I could tell. The new HLT thread on last week’s Follica news is already 10 pages deep. At this point, it seems like a few people have realized what was missed before and the pdf has been repasted several times.

I did not want to share this document right away. On Twitter, I first asked several members of the Follica team to contact me as I wanted permission to share the cartridge, dropper and new patient hair growth photos. In the past, several Follica staff members have responded to my requests and questions.

However, I got no response from anyone this time around despite two attempts on November 21 and 22. I did not mention anything about Minoxidil to them, so there must be another reason for the secrecy.

Follica Might Start off with Minoxidil :-(

I have now found the same document available online here. On page 46, it states: “Proprietary Minoxidil cartridges for use with smart dropper”. Crazy to see this after years of speculation.

For many years, most of us have assumed that Follica would use a compound that would at the very least be Minoxidil PLUS something else. Many people assumed that the second compound would be based on valproic acid, since Follica even has a patent in that area. So this news is a disappointment.

However, two important points to note:

  1. The above linked conference call pdf was published around three years ago and is old news. Moreover, things may change further before the end of 2020.
  2. It will be much easier to get initial US FDA approval for a microneedling based treatment that only involves the addition of Minoxidil. After all, topical Minoxidil has been approved as a hair loss treatment for decades. Some people even take the more dangerous oral Minoxidil to treat their hair loss.

Correct microneedling and wounding in combination with Minoxidil seems to give excellent results (e.g., see Rachita Dhurat and her India microneedling work). Most people who are experimenting with at-home microneedling are not doing it correctly. Hopefully, Follica’s micro-needling device in the hands of a professional will be much superior.

Even more hopefully, Follica will add other compounds into the mix down the road. Perhaps even something like wounding plus mesotherapy with Dutasteride.


November 21 2019: New Follica update via Puretech’s latest November 2019 presentation. (h/t “Toccata”).

Follica FDA Filing in 2020

They seem to be calling the product FOL-004. Previously they have used FOL-001, FOL-002 and FOL-003 in various clinical studies. The final name is supposed to be the acronym “RAIN”Note: The unrelated company Follicum labels its hair loss product as FOL-005!

Puretech has now raised its stake in Follica to 78 percent, indicating major optimism.

On page 32 of the presentation, it says that:

  • “Interim clinical readout of optimization study in AGA” was completed in 2019. Checkmark next to it on the left stands for completion.
  • In 2020, the company plans to get “Topline results from pivotal study in AGA” and also go through with FDA filing. Assuming data are supportive.

On page 40, they have a crown hair growth before and after photo. Pretty decent results in my opinion. It says the after photo is 85 days post the “screening” before photo. Not sure how many treatments were required over those 85 days.

The still use the phrase “newly created hair follicles”. Created via the wounding and microneedling procedure using Follica’s proprietary new device.

Apparently, the procedure will just take 5 minutes. Fingers crossed, maybe we will finally get this much touted product to market by the end of 2020.

The below post was published on May 12, 2019. See bottom of page for possible Follica Trial recruitment information.

Puretch Pipeline

Follica Clinical Trial Schedule

A few weeks ago, PureTech released its 2018 annual report. On page 31, you can find the summary for Follica. PureTech owned 62.3 percent of Follica at the end of 2018. Follica also updated its site recently as noted by one of this blog’s astute readers last month.

In the above linked PureTech report, the Follica page mentions that the company will start its “pivotal study” in 2019. They have already conducted three clinical trials in the past.

Per one definition, Pivotal study means Phase 3. Per other definitions that I have read, it means Phase 2b. Either way, we are making major progress. Considering that Follica’s methodology involves wounding and then use of existing drug compounds on the scalp, perhaps they can get away with a faster approval process.

I have covered Follica numerous times on this blog, only to be disappointed at its speed of progress each time. However, I have some interesting news to share about the company that I will split between two posts.

Recruiting Volunteers

While going through their new website in more detail, I noticed that one of their clinical advisers was a Dr. Jeffrey Dover. His was the only name that I did not recognize in the list. A little bit of research, and I found that Mr. Dover works at SkinCare Physicians.

I then went to SkinCare Physicians’ Twitter feed, and lo and behold, the below Tweet from February 14 says it all. I have no idea if this recruitment period is over, but please only call them if you are certain that you fulfill all the requirements, including travel to Chestnut Hill, MA). And do not call them just to ask general questions!

Update: Had to remove the embedded Tweet after a request from one of the company’s representatives. She emailed me and said that they were bombarded with a huge number of calls, with many volunteers not fully realizing the very specific travel requirements. A number of callers even pleaded to get in despite living in different countries! And of course many called just to ask general hair loss questions despite my explicit warning above :-(

128 thoughts on “Follica Pivotal Trial in 2019, FDA Filing in 2020.”

  1. excellent coverage Admin as always! Follica has us all excited obviously especially Mjones lol. Quick question does anyone know where to get legit Avodart by GSK without a prescription?

  2. Does anyone know if using a wounding system could hinder the success of a ht down the track? I hope not cos up back and a ht up front could be the magic bullet.

    1. Don’t ever ever ever do a HT. Not only do you get scarring in the back of your head, what they don’t tell you is you get scarring at the recipient site also, creating a cobblestone appearance. It’s awful and you’ll never be able to shave your head. HT’s ruined my life and my only hope is a real cure or stem cell unlimited donor hair. If you think bald is bad, there’s nothin worse than transplants.

      1. Get lost. I had a hair transplant just last year. Best decision I ever made. I tell people all the time. DO IT. 90% success rate. You went to Turkey I bet, had a bad procedure and now your telling people not to do it.

        People should really do it in America we’re the doctors in the greatest western nation are well trained. You leave little information. HT’S WORK. I am proof

  3. Great info admin.

    Small gripe: The tweet is hilarious, it has a picture of a guy with a full head of hair frowning in the mirror lol.
    Maybe you could argue his upper right hairline near the temple is diffusing a bit but this is a far cry from the state most of us are in lmfao.

    1. I would say the picture is just a marketing technique to attract people who want to have a head full of hair like the model.

  4. Time to end the Griping and Misery as companies need to come out with something, anything, that works. My fingers are crossed for Aclaris and JAK and they will show photos assuming they are successful, or anything else that works.

    1. Lol No no it’s fake news. dad said no good science can come out of Japan. Not until the Meiji restoration because their battery technology can’t save their debt to GDP. Trust me on this one.

  5. Pivotal trial can be phase 3.. Why would they have an optimization study for a Phase 2b trial when they conducted 3 trials already? This is most likely their phase 3.

    1. No, it is not.
      The three trials so far have been phase I, IIa and IIb.
      The pivotal trial is an optimization one and there should be a phase III, if they want to get an FDA approval and the green light to proceed with releasing their treatment.
      Follica began in 2006 and it’s been 13 years already.
      An effective treatment, that can be profitable and has virtually minimal side effects, is usually fast-tracked within less than 10 years.
      I know it’s hard for most to come to terms with reality, but that’s the reality.
      Follica’s RAIN treatment is BULLCRAP.

      1. No. You’re wrong. If they conducted a phase llb already why would they have an optimization study for another phase llb? A pivotal trial is a trial that will have data to present to he FDA for market approval. Just look it up.

        1. It’s an optimization trial for the phase III trial, pal.
          Look at the logistics.
          The pivotal trial is to last three months, do you really believe a phase III trial would last three months?
          Bwahahahaha
          Enough with this BS!

          1. Wow you are dumb. There are exceptions to Phase lll just like any else. Everything they are using especially drug compounds are already on the market and are understood. You need to do more research buddy. Yes it’s an optimization study before the phase lll trial? When did I say it wasn’t? Get outta here with your bs already.

    2. If you google minoxidil before/after results you find more impressive pictures than the one mentioned on p.40 of the slides. Sry for being the pessimist here but since this product contains market proven ingredients; it’s really unlikely that this comes even close to the bang we’re waiting for. Also wounding which is basically micro needling is nothing new. All in all it just seems like a more controlled version of these treatments which might be the only new thing here.

  6. Excellent detective work admin! Thank you for keeping us in the know! Looking forward to your follow up post.

  7. I just hope that after 25 years of waiting, the name of this blog corresponds to the truth … the end of baldness in 2020

  8. “However, I have some interesting news to share about the company that I will split between two posts.”

    There’s another post to come? You tease. Great find btw,

    1. Haha maybe I should change that…second post is 50/50 at the moment depending on external circumstances. But it will likely happen sooner or later.

        1. As a blog owner, I cannot recommend unknown online sites (especially in other countries) for purchases of prescription drugs :-(

          You can go through my main Avodart testimonials post and see what others have said about legit sites in the US…close to 400 comments in there.

          1. Hi admin one last question do you know of anyone that has contacted Dr. Lupanzula in Belgium. I left him multiple emails no answer I wanted to inquire about his Topical liposomal Dutasteride. I’m wondering if he makes it in house or out sources. In that case I would just try and reach the pharmacy. Any input would be greatly appreciated.

            1. No I never heard about anyone getting the product from him :-( I have never even emailed him as far as I can recall.

  9. Yoda looks 100 years old after 35 years of continuous, mostly high strength minoxidil use wreaking havoc on my skin…NOT! Just wanted to feed the trolls, I have awesome skin and told I look five to ten years younger than my actual “geriatric” age of soon to be 57. Don’t believe everything you read on the internet boys and girls!

    1. Sorry but minoxidil does cause collagen breakdown that can manifest into aged skin appearance. Just because you’re lucky doesn’t mean it doesn’t happen. If you get off being a troll you’re a jackass.

      1. The trolls are the ones who scare people off of trying things and exaggerate side effects Stevie. If minoxidil DOES cause aged skin appearance how could I be “lucky”? Can you please provide studies and photographic evidence that topical minoxidil causes “collagen breakdown that can manifest into aged skin appearance”? Or are just just talking out of your butt? Hence forward to be known as your “troll hole”! :-)

        1. I love these guys that want to blame their aged skin, limp dicks and any other sign of aging on hairloss meds. Take care of yourself and you’ll forestall aging issues. Eat like crap, don’t exercise, drink like a fish, smoke, be unhappy and you won’t. Simple facts from Yoda, old man of hairlosscure2020 who still has hair after 35 years of the fight.

          1. Haha! Btw there were a few people who commented in the Avodart testimonials page who were older than you for sure. Several over 60-years-olds have posted on this blog before, still hoping to get their hair back.

            1. Trust me Admin, the hunger to have a full head of hair never stops no matter the age. Although it’s much more traumatic to be losing your hair in your late teens, 20’s even 30’s than in your “golden years”. This I know from experience, am grateful for the meds we have now that kept me from going full on bald and hopeful that the future will bring better treatments for all, young and old!

                1. Trafficant…priceless, he was Trump before there was Trump, just a bit less of a douche bag. Although the Donald sets the bar pretty low! Here’s to new treatments and a new president in 2020! :-)

  10. Follica is interesting. However why it sounds like every single company has to die for some years then come up with ” Uh-do-not-forget-us announcement”

  11. Replicel / Shiseido’s RCH-01 RESULTS RELEASE IN TWO MONTHS, according to email from their team’s doctor.

    We live in an exciting time, everybody! Let’s not be so PESSIMISTIC, only observant. Past few years have been game changing, both in research and and steps toward commercialization. All this will be over before we know it. Either RCH-01, Tsuji, or somone out of the blue will grab all the cash in a couple years, if not sooner. Sure, all this stuff will be expensive but I’m willing to put down some serious cash to get my hair back.

    Just think of all the other organs they’ll be able to regenerate in the future – hearts, lungs, livers, eyes… Hair is BS compared to the real industry in regenerative medicine. However, it is a gateway as it’s the easiest to replicate.

    Sorry for such a long comment; I know this isn’t my blog but this $$$tuff is almost here.

    1. I second this. Well said.

      That is big news even if its a failure. If they are scheduling a news announcement that tells me they actually have something because why would you schedule out 2 months to announce a total failure? I doubt seriously it will rival tsuji complete regrowth and follicle size modification. But hey only time will tell good luck to us all.

    2. Greg, Love the Replicel info.. Thanks for sharing! I hope that e-mail source is legit and you’re not just messing with us! I also hope they live up to their confident statements. It’d truly be amazing.

  12. I know their was some people waiting for my reply in the tretinoin thread.. John yu, andy and mjones.. I have posted replies to your questions.

    1. Thank you Quentin. I’m going to buy amino acid blend vitamin. I eat lots of healthy foods like avocado, dark leaf vegetables, legumes etc.

      Nice find on follica admin. Let’s hope they pull through with nice density results so we can actually call this a real treatment and not just weak regrowth like 8%. If they can pull off 100cm2 terminal then we got good stuff coming our way. Time will tell….

  13. https://www.hairlosstalk.com/interact/threads/follica-protocol-to-use-valproic-acid-patent-march-21st-2019.122520/

    Follica new patent :

    The main drug is Valproic Acid ! They talked about the drug applicator. They also talked about differents compounds as proteasome inhibitor such as lactacystin, a peptidyl aldehyde or pentoxyfilline.
    Minoxidil is an optional and additional agent (or diazoxide or phenytoin).

    ” The drug applicator may be programmed remotely using an external or mobile device via Bluetooth or other wireless communications. In an exemple, the total dose is 1ml per treatment and is deliverediun five pulse of 0.2 ml each. The drug applicators maybe programmed to perform a Massage + Dispense cycle for 1 minute that is followed by a Massage only cycle for 5 minutes”

    ” Different drugs or compounds may be used including proteasome inhibitor such as lactacystin, a peptidyl aldehyde or pentoxyfilline (PTX) and the active ingredients descibed in section 6″

  14. I know it says they are in Phase II or starting III but I have been all over the US Clinical Trials website (https://clinicaltrials.gov/) and can’t find anything about PureTech or Follica studies, has anyone found their phase trials posted there? If they are going for FDA approval doesn’t it have to be submitted on the clinical website?

  15. JohnP I looked as well. Puzzling. Anyone know when they expect to actually begin the next trial?..my hope is follica will get me some regrowth then try and slow down the thinning with prp. Then annually go back and get the procedure done again etc..I dont think us non minox/fin users can do much else until samumed comes out with their product…hopefully.

  16. What is the expected order and dates of these products coming out?

    Sheisedo this year? Histogen this year? then Samumed and Breezula?

    1. You guys need to flush histogram breezula and rivertown down the mental toilet with their flash on before flash off after I actually saw a legit Photoshop edit on (name removed) literally copy pasted false image for that brotzu crap.

      For those of you new it’s basically Tsuji shiseido, follica ,Jak, in vitro hair, Tissuse ,Terskikh, repunzel and hairclone. And with great bitterness POLARITYTE since their technically already doing it but not making it available to us.

      Some worthy pipeline side treatments might be follicum samumed.

      Thats basically absolutely it.

      1. Egghead your list is way too short! Yes there are a lot of disappointments and snake oils but there also are at least 30 more new drugs already in Human Trials. Hair Loss is just so complex to keep the overview.

        Also dont Forget that beside Hair Loss drugs also Anti Aging, Stem Cells, Bio Printing and Regenerative Medicine is making fast Progress. These also are in Human Trials already.

  17. I tried to sign up for the trial, but they are specifically looking for participants in the Massachusetts area.

    The comment earlier citing the 13 year process for follica isn’t fair grounds to call it “bullcrap”. The average time span for a medication to go from concept to public availability is 12-17 years. I’d say they’re roughly on schedule.

    1. LOL
      It’s 15-20 years for compounds, which take time to be manufactured and be tested pre-clinically.
      How on Earth would dermarolling be tested pre-clinically?
      LOL
      Enough with this BS!

        1. ahahahahahahahaha
          It was more of a rhetorical question.
          There is actually no need to carry out pre-clinical tests.

  18. We’re so f#$%ed…..jk I agree with egghead. Histogen, and ruvertown especially rivertown is scamville! Breezula is legit but 10 years too late in my opinion and it sounds like a pain in the ass to apply 2x a day. Diffuse thinners like me will look messy and sticky with it in my hair. We need next generation treatments like jak, sisheido, follica, riken etc. Like I said earlier I’ll still take anything just can stop loss and regrow.

  19. Nice find Left4bald……….and the excerpt below may explain why the optimization study has taken so long………..more a matter of when to apply: [0009] In some embodiments, the valproic acid composition is administered once reepithelialization is completed, or 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 weeks after integumental perturbation. In some embodiments, the valproic acid composition is administered once reepithelialization is completed, or at least 2, 4, 8, 10, 12, 14, 16, 18, 20, 22, or 24 hours after integumental perturbation. In some embodiments, the valproic acid composition is administered once reepithelialization is completed, or at least 1, 2, 3, 4, 5, 6, 7 days after integumental perturbation. In some embodiments, the valproic acid composition is first administered 1 day after integumental perturbation. In some embodiments, the valproic acid composition is administered before and after integumental perturbation. In some embodiments, the integumental perturbation is performed after 24 or more hours of valproic acid composition administration

    1. Lmao right?!

      We can grow an entire new human from a Petri dish that lives forever but hairloss phew your talking a steep game buddy.

      But jokes aside I must say in the last 6 years of haunting this blog I will say with all my cynicism the next 24 months are appear to be the strongest momentum in all the years I can remember.

  20. Just noticed in your link to the study recruitment ad, at the bottom, it says that: “The study will last up to 12 weeks”. That’s seems like a short time period for a pivotal study (which I would think would require a little longer term safety data) making me wonder if this ad is for the optimization study or the pivotal study. Either way, the great news about that time period is that it sounds like they know very quickly how well the treatment works. Wondering if anyone who has called can shed any light on which study this is for.

    1. I though of that, although since they started recruiting in February, I assumed that the study would not start for at least several months. In fact one person emailed me and said they are still recruiting, but only people residing in the same state. Making in sound like recruitment for a yet-to-start study, or one that started fairly recently. Could still be the optimization study if that one has not been completed already.

      1. Thanks! It does say “new clinical trial”. Probably just speculative wishful thinking, but when they say the trial will last “up to 12 weeks”, it indicates the possibility to me that: 1) the treatment produces a noticeable result quickly; and 2) the treatment is in high gear and headed to market.

  21. I didn’t do this, but what’s the problem with asking general questions? I think it’s normal to want to know more about the drug in question that might be tested on you. I mean, they could just say they don’t/can’t answer certain questions. I don’t see how that’s rude or out of place but maybe I don’t totally understand how clinical trial phone lines work.

  22. I strongly believe RAIN will hit the market like I have been saying. My only concern is will this work for people who have been using minox for over 5 years? Will this new treatment work long term for as long as you use it? Many people lose effectiveness of drugs like fin and min after few to several years of daily use. Finally, will it be 100 terminal full thick hairs or 25 per cm2. What is neogenisis hair? Newly created follicles that will go terminal after months of use?

    Either way cots is my boy and I’m sure he will release something as he claims 4x better than what we have. I’ll take that for sure.

    1. @MJones : According to their latest patent, Minox is an additional et optional agent.
      The main drug will be Valproic Acid !
      They talked about the drug applicator and about differents compounds as proteasome inhibitor such as lactacystin, a peptidyl aldehyde or pentoxyfilline.

      Minoxidil is an optional and additional agent, if it’s not Minox they talked about diazoxide or phenytoin.

      We don’t know for sure, for the results, but for now, it would be 25 hairs /cm2.

      Neogenesis is for new follicle generated ! All your questions are in their patents.

    2. I don’t understand how these newly created hairs don’t continue to fall out? Is there anything that says they won’t?

  23. Hi admin, You maybe interested in this study titled : 10-Year Finasteride Study: First to Investigate Long-Term Effects and Safety.
    Here is an an overview of the study and a link to download the study as PDF :
    https://www.bernsteinmedical.com/research/10-year-finasteride-study-first-to-investigate-long-term-effects-and-safety/
    Interesting findings :
    – Finasteride never loses effectiveness over time.
    – The patient response at the first year can be used as an indicator of weather the patient is a good candidte to coninue with Finasteride.
    – Patient over 30 tend to benefit more than others.

  24. I was an excellent responder to finasteride. Stopped my hair loss at nw 1.5 for 13 years then one day my hair started miniaturizing again and scalp pains returned. So your study isnt accurate. …Propecia loses its power to fight of mpb over time.

  25. There was mention of a split between two posts, what was the other post? This is the only near term interesting thing, than tsuji and tissuse.

  26. Great news, finally something that works.
    Wonder how it will work if used in conjunction with dht blockers such as finasteride and avodart.

  27. I brought this up before…the company says NDA filing, FDA, pivotal study, etc. which makes you believe they are going through clinical trails however I have been all over the US Clinical Trials website (https://clinicaltrials.gov/) and can’t find anything about PureTech or Follica studies, has anyone found their phase trials posted there? If they are going for FDA approval doesn’t it have to be submitted on the clinical website? Unless they are doing their own private trials which I’m assuming means they could have released this earlier as a cosmetic treatment no? Unless unless they are doing trials in another country. Unless unless unless they only want FDA approval for the proprietary (hardware) device?

    1. My guess is that because they are using existing compounds and a microneedling type device, perhaps they get away without having to do normal clinical trials. I am also confused about some of the terminology that Follica/Puretech uses.

    2. It’s interesting, and it’s actually a matter of constitutional law versus regulatory power. The FDA has gone to court (and sometimes lost) over the matter. Obviously, valproic acid is prescription-only in the US. Topical use of valproic acid would be “off-label” use, which means it’s perfectly legal for a doctor to administer it this way, but illegal for a company to advertise or promote its use (to healthcare professionals and particularly to the public). However, pharmaceutical companies have successfully argued that it is an issue of freedom of speech, and that there is a difference between promotion and protected “communication” of facts.

      Follica probably doesn’t need a new series of trials, provided it is armed with enough lawyers, and that its “communication” of the benefit of topical valproate (and its hazards) is “truthful and non-misleading.”

      Moreover, it is apparently within the FDA’s power to simply add new labeled uses of a drug if it is satisfied with a company’s research without requiring full trials.

  28. I’m just disappointed that we waited 15 years for that result. The fda needs to overhauled and more lax. Microneedling and adding valproic acid shouldn’t require 15 years of trialing lol. Anywho I’m not surprised that this is the result. Every new treatment is just going to be marginally better than the previous. Cb, sm, follica, all will have similar results. The real deal wI’ll be hair cloning but who knows if that will ever see the light of day. I also think follica will be good for bald spots. If you are diffuse it may rip or damage healthy hair. I don’t see the 30cm2 hairs they mentioned or the 100cm2 neogenic. Of course I’m just speculating here and they may release much better pics in 2020 and they are just low balling now for marketing purposes.

    1. Mjones stop crying every time you come, you are the most tired that exists!! don’t you see the 30 hairs per cm2?? then come closer and count!! you really have the intelligence of a primate if you want to observe 30 hairs per photo!

      Follica has announced many times that it will also improve the existing one! cielos sees a professional who treats your insane mind

  29. Mjones good points. I think the next 2 treatments to come out will be very similiar to each other results wise. Keep in mind follica may be highly beneficial to the person that has light to medium hairloss. So let’s say you are the guy in the pic and your starting point is the “after” pic on page 40. Now that guy will go from “thinning” appearance, to descent head of hair. But anyone, let’s get this rock n rolling cause we need something now!

  30. Admin,
    Are you aware they are potential plans to run another pilot with an updated “device” ? I was told to monitor SkinCare Physicians’ Twitter feed for any potential updates , because if they follow through with the new device they will be looking for local volunteers located near Boston .

  31. I’ve been following Gelesis’ (now called Plenity: https://www.myplenity.com) progress as it was Puretech’s first drug to be FDA approved (April 2019). I thought it was already out but turns out it will be 2Q 2020.

    If we take *that* timeline into consideration, then an FDA approval of Follica in 2020 will have a market launch of about a year and a half afterwards. If the wounding device requires mass production and training, possibly more.

    Meaning a more realistic release period is 2021-22, IMO.

    And then there’s this bit: “Attractive physician practice economics consistent with in-office aesthetic procedures”

    That has me worried, being that PRP needling is often in the $1000 range; even a shallow depth facial needling session is $300+. Follica most likely requires a lifetime dependence on in-office treatments (probably sold as bi-yearly packages, like 6 sessions 4-6 weeks apart, i.e. PRP), combined with a topical that will probably be $50-$100 a month, and we’re talking a yearly expense in the multiple thousands, and a whole lotta hassle, especially for maintenance-statistical improvements.

    So I hope Puretech knows how to make this ‘attractive’ to us.

    1. If that’s the case, then lots of luck to them. In 2022, there could be two new topicals out, so why would anyone want to go through the added expense and hassle of a in-office treatment when there are other options out there (2022)?

      That makes me wonder if PureTech even studied the competition well enough.

  32. Rodri…..seriously? The way you respond back shows your intelligence level. I’m just stating the reality of it. If you find those results acceptable for 15 years of trials and delays then good for you. Enjoy. P.S. control your anger buddy. I have helped many newbie hair loss guys on here. Hooefully they took my advice the past few years and got on the big 3.

    I don’t join to insult people or call them primates. You should see the mental therapist. I’m just fine.

  33. I’m with Mjones. At the moment, this doesn’t seem that exciting.

    For me, it looks microneedling and minoxidil. If it provides significant results and noticeable thickening, then fair enough. But if it offers minimal benefits, and needs to be done every three months or so, I’ll be disappointed.

    Of course, results are key. They are the most important part. But practicality is important, too. Especially if results are minimal.

    If a treatment can make significant, noticeable changes to my hair, I’ll put up with the hassle that comes with it. I’m sure most of us would. But if a treatment makes the kind of improvement that isn’t obvious, where you aren’t really sure, that’s not worth getting excited about.

    Is anyone else excited about Samumed or RCH-01?

    I believe RCH-01 is supposed to be a better version of PRP.
    I don’t know much about Samumed. Can someone give me a basic explanation of how the treatment is supposed to work? I’ve read various articles, but a surprising amount don’t explain what actually happens!

  34. I would be excited if Follica was a home treatment and affordable. No chance I’m going to an office for it for the rest of my life. What a hassle.

    I predict Follica will have very disappointing sales results once the newest topicals come out in 2022.

  35. If there 2020 top line results show that same guy’s bald spot filled in then I will be very happy. But if this is it then it won’t provide me much benefit. The little hairs that grew between the comb overs aren’t enough to make a difference. I go more regrowth using topical 82M that added density all over and grew hair along my hair line. It only lasted 4 months though. I read over at hlt that the follica results go back to baseline after 6 months. So this will be a continously needed procedure. Don’t mind that as long as it produces visible dense hair.

  36. If it is a choice between Nothing and Follica I side with Follica. Life is getting short and the wait has been long I for anything that will grow hair that is out Now or at least in 2020. And, hopefully this will work all over the hairline.

    1. I have said this before and it will make me the devil to most of you. Hair system, Norwood 7 to full coverage in 2 hours, guaranteed results visible to the naked eye, plus choice of hair colour.
      The only drawback is it needs a re-glue at week 4. Perhaps a better adhesive that would make them last longer and more tolerable to heat would be the next hair breakthrough as my frequent trips to Africa and South East Asia have me avoiding them recently.

  37. Genuinely not sure what to make of this. And given Follica and puretech have been so secretive up until this point, could some form of subterfuge be entirely ruled out? I mean, 10 plus years and it’s rogaine plus wounding? Surely it wouldn’t have taken that long to put out, even at the FDA being their most obstinate?

    Plus add to that that the first pics Follica have released, granted not widespread but put out there online for the lurkers to find, are not mindblowing paradigm shifting pics. The angle is different and it just seems that if Follica want to make a dent in the market, surely they know they have to have something better in their arsenal and I’m not convinced that they don’t either btw. And has anyone explained that new bit of info on the website:

    CAUTION: Investigational device and new drug. Limited by United States law to investigational use.

    Anyway, I get the feeling (or I hope anyway) they have more to reveal and are playing a bit of a long game here.

    1. This is complete speculation but it may be that they have added the “CAUTION: Investigational device and new drug.” notification because they are planning to market the treatment, at least in the near term, without FDA approval………see this link stating how the term “Investigational” can mean off label use of an approved product for a different use or approved for use in a clinical trial.
      https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices. This could be either because the “device” does not yet have approval or because the compound requires a prescription…..i.e valproic acid.

  38. I agree with mike. Mike im hoping this is a giant marketing gimmick to play with their competition. It just doesn’t make sense to have this little regrowth after all these trials and research….we shall see.

    1. Mjones, why did you talk about Folica so much before? We all knew they have been delaying for 15 years or something right? it is just better absorbing Minoxidil using Dhurat findings I am guessing.

  39. I’m most interested to see results in the frontal hairline region of the scalp. If they’re similar to the crown result pictured I’ll be very happy.

  40. Mjones the guys on another site swear they are using minox. Please say it ain’t so??? I put a dab of minox on my scalp last night and my heart was racing the entire night.

  41. Random question.

    Recently, I’ve noticed that my facial stubble is not as dense as it once was. It isn’t patchy, but it was much more dense a few years ago. I’m 38 at the moment.

    Same thing with my bodyhair. My legs and chest used to be very hairy. Not so much anymore.

    So, I’m wondering if there is a connection with my diffuse thinning? Probably grasping at straws, but I thought it was worth asking.

    Many years ago (ten years plus), I took Roaccutane. Could this have kick-started something?

    1. Paul,

      I have been suffering from diffused thinning as well for the last 5 years. It started right when I was taking Roaccutane.

      At first, I suspected it. I encountered a couple of forumers whose hairloss seemed to start under isotretinoin as well. Eventually, I moved on and started worrying about how to prevent hair loss.

      There could be something.

  42. most probably follicas realized that something serious is about to come out … so they decided to take a step forward in an attempt to earn something … a bit like Brotzu and all the others …

  43. I have to say I really dissapointed that after all these years that all follica has is a fancy micro needle device with minox. Its absurd. I read the literature and it’s TRUE, that is all it is. They should give half of all proceeds to Dhurat as she was first to discover this potential. So we have not made any real progress over at upenn after all these years and all these studies. The same people who cant tolerate minox get screwed again. It’s such horse sheet. I’m so ticked right now. Just really upsetting.

  44. Has anyone experiment with using caffeine instead of minoxidil in concert with microneedling? Rachita also did a study claiming that it was just as effective on its own as minox. I’m thinking about that combination alongside some botox injections to the scalp because, apparently, scalp tension is a big contributor to hair loss.

  45. Minox with microneedling?
    Another one bites the dust.
    These late developments show that aside from an accidental discovery the only hope is gene modification which is decades away.
    Hair cloning is just hair transplant with unlimited donor hair and results will vary, not mentioning that most of us will not be able to afford it for a long time.

      1. @ Scott, Right! Also Taisho Pharma cancelled as well and Histogen back to Phase 1 … but on the other Hand there have been so many new stories as never before! I really want to hear more About Exosomes.

  46. In my inbox today – perhaps nothing new for most of you:
    “RCH-01 – RepliCel’s cell therapy for the treatment of Androgenic Alopecia has been the subject of a successful phase 1 trial in Europe and a clinical study now complete in Japan. Shiseido is expected to announce soon whether it will commercially launch the product in Japan or conduct further development and clinical testing. RepliCel will not plan for a phase 2 clinical trial of this product until it has the RCI-02 injector commercially available to use in such a trial and it has clarity from Shiseido regarding its plans for the product in Japan.”

    1. I had an update about Replicel also:

      “RepliCel is planning a Phase 2 trial to answer important questions like: what is the best dose (number of cells) to see intended results and how many rounds of treatments are required to achieve intended results. Trial success will be measured by assessing changes in terminal and vellus hair density as well as cumulative hair thickness **over a period at least one year.**”

      So they won’t start a phase 2 until the Injector is released (2020-21), and when they do start the trial, it will last *at least* one year.

      That’s gotta be around the five-years-away mark, not counting the phase 3 trials, ‘waiting for data’ period, registration and the rest of the inevitable delays. If Shiseido doesn’t come through in Japan, then we got Replicel 2030, if at all—they’ve been at this since 2003 and they still don’t know if it works—not good.

  47. I agree with Admin that we shouldn’t jump too quickly to conclusions based on a conference call pdf over 3 years old. I’m not sure why minox plus micro-needling would even need FDA approval. There must be a reason why 3 years later, they are just about to begin their pivotal study. One possibility is that they are using a different compound (like valproic acid) at the time of disruption and then using microneedling/minox to sustain.

  48. Microneedling coupled with minox. I dont know if I should laugh or cry. I’ve been waiting two decades and all cots is doing is trying to improve dhurats simple micro needle with minox regemin. So sad. He said almost a decade ago that another treatment is right around the corner. 10 or so years go by and this is what they have??? I just cant believe it.

  49. Tsuji. Tissuse. Rapunzel hairclone and maybe big maybe shiseido is all thats left.

    Guys weve been here since 2014 … Topicals are NOT and will never be “cureworthy” its cloning or nothing dont get your hopes up for peach fuzz diffuse terminal treatments you have to squint to see or accidentally imagine

    1. Agreed. I’ve always had that approach. Anxious to get an announcement from tsuji soon, looking Forward to TissUse trial in January.

  50. Out in the real world: Guys getting incredible results with minox and needling

    Here in the comments: Reeee you are doomed to baldness

  51. Follica could pleasantly surprise yet, I remember back in 2017 follica tweeted:

    Rox Anderson MD: “This isn’t simply a combination product, we’re growing a new set of follicles and talking to them”

  52. How hilarious! As always the long drawn out trial to nothing more then minoxidil and microneedling! Hahaha! How hilarious! Ive been doing this treatment at home for 16 months now. Yes ive gotten decent results with definite regrowth but to pay all that money just to have follica do it for me is a joke. This is definitely not ground breaking. You want the same results? Go buy an at home microneedling device for a few hundred, and save yourself thousands. Another mediocere treatment.

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