Follica Pivotal Trial in 2019

See bottom of this post for possible Follica Trial recruitment information.

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.

Follica 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 :-(

72 thoughts on “Follica Pivotal Trial in 2019”

  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.

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

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

  7. “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.

  8. 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! :-)

  9. 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”

  10. 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.

  11. 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….

  12. 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″

  13. 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?

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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?

  22. 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.

  23. 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.

Leave a Reply

Your email address will not be published. Required fields are marked *