Follica Presents Topline Data From FOL-004 Treatment

Updated 12/19/19

Today, I received an email from Follica management which shared the company’s latest press release. The company has just announced positive topline data from its FOL-004 safety and efficacy optimization study which was carried out in 2019. According to the release, the study was designed to determine the optimal treatment regimen involving Follica’s wounding device and topical drug application. In the study, three separate groups of male subjects received a unique treatment regimen of FOL-004.

Here are the highlights from today’s press release:

  • The best performing treatment group/regimen in the study produced a 44% improvement in non-vellus hair count compared to baseline after 3 months of treatment. Non-vellus hairs include terminal and intermediate hairs. These are hairs which are visible and cosmetically significant.
  • Across all three of the treatment groups, the overall improvement of non-vellus hairs was 29% compared to baseline after 3 months.
  • The safety and efficacy optimization study comprised 48 male subjects, ages 18-40 years old with a Norwood 3 or 4 degree of baldness.
  • Follica’s skin disruption device is now called the Hair Follicle Neogensis (HFN) device.
  • A phase 3 or pivotal study for FOL-004 is expected to commence in the first half of 2020.

We know that Follica’s treatment begins with a 5 minute office procedure where the HFN device is administered to a patient’s scalp. Here’s an interesting quote from today’s press release which gives more insight into the daily maintenance routine of FOL-004. “Follica’s approach is based on generating an “embryonic window” in adults via a series of skin disruptions, stimulating stem cells and causing new hair follicles to grow. This process of hair follicle neogenesis involves minimal daily interruption and is enhanced through the application of a topical compound as part of the treatment regimen following HFN.” 

For a visual example of the FOL-004 treatment on the crown of a male subject please review the article below.

Original Post on 11/21/19

Follica has released its first before and after images from an optimization study of its lead candidate hair growth therapy FOL-004.

The slide below was shared in a PureTech Health corporate presentation on November 1, 2019. PureTech is the parent company of Follica, a well-known hair growth startup based on the research of Dr. George Cotsarelis of the University of Pennsylvania. Follica has been incorporated since around 2007, but this is the first time hair growth result images have been shared from the company.

https://puretechhealth.com/reports-presentations

Points of interest from the slide:

  • The in-office duration of FOL-004 is slated to be only a 5 minute procedure. 
  • Pharmaceutical compound (still undeclared) is applied following skin-disruption treatment.
  • No mention of the ‘at-home’ portion of the FOL-004 treatment.
  • As noted, Follica’s treatment is now referred to as “FOL-004” instead of the previous acronym RAIN which stands for regeneration abrasion induced neogenesis.
  • Application to the FDA for commercial approval planned for 2020.

For an extreme close-up of the results images click here. 

For those that clicked on the close-up image, let us know your feedback in the comments section below. One observation I will share, in the before image I notice what I would consider to be a “bald spot”, the center of the crown is mostly just scalp with a few sparse hairs growing in. In the after photo, even though the angle is not the same, the crown displays hair that has thinned, but there is no bald spot anymore, there is no area of the crown that is predominantly just scalp. For a little under 3 months, this is a noteworthy result.

Of all the companies developing hair loss treatments, Follica has one of the shortest paths to market with a potential to reach consumers in late 2020/ Q1 2021 if all goes well.

126 Comments

  1. Follicle Thought on November 21, 2019 at 9:18 pm

    Thanks to KD for sharing the link to the presentation in the previous article.



    • KD on November 21, 2019 at 9:32 pm

      No prob! I also this result was very interesting and gives me a bit of hope for FOL-004 to come out asap.



    • James on November 29, 2019 at 1:02 pm

      Is it worth me waiting for these treatments before trying minoxidil and derma rolling? I’ve felt with ED due to other reasons and i refuse to do anything such as fin that may cause it long term. I’m like a NW2 but with diffuse thinning on top.

      Also will this FOL-004 prevent hair loss down the line in the same way fin does? 5 min procedure you’d hope it wouldnt cost too much…



      • Follicle Thought on November 29, 2019 at 11:11 pm

        James, I don’t see a reason to not try minoxidil and dermarolling in the meantime. There’s no risk of ED related side effects and you could potentially gain some ground while you are waiting for more advanced technologies. Many people already are using the minox-rolling combination.

        I don’t believe FOl-004 would prevent hair loss but perhaps keeps follicles healthy as you continue treatment, so you could say it wards off hair loss while you using the treatment.



    • vincent Williams on March 19, 2020 at 12:11 am

      How long does the third phase take, and how long does it take to go public? I don’t want to be disappointed again when some other company’s products fail.



      • Follicle Thought on March 20, 2020 at 1:09 pm

        Vinvent, the phase 3 usually takes 1.5-2 years to conduct the trial, analyze the data and receive approval from FDA or other regulatory body. Sometimes the phase 3 can be a little bit shorter, but mentioned timeline is typical.



  2. Alex on November 21, 2019 at 9:50 pm

    Thank you for sharing the real close up image of this guy I have not seen it like this online yet. I can see the change easier from first photo now. This has potential at least we can say.



  3. C on November 21, 2019 at 11:16 pm

    Some might say this bit of news is a quantum leap in the battle against alopecia. I, for one, ain’t one of them. After all, this procedure relies on the usage of Minoxidil. Come on, HairClone; Tsuji; Tissuse…don’t let me down!



    • Serg on November 21, 2019 at 11:25 pm

      C you are investor with another company or something?



      • C on November 21, 2019 at 11:34 pm

        I am not an investor. Rather, I am a doubting Thomas who is bloody sick and tired of these lacklustre ineffective treatments for alopecia.



        • Serg on November 21, 2019 at 11:53 pm

          Ok fair enough, all of us are not doubting thomas though…



    • Yoda on November 22, 2019 at 5:19 pm

      C, Where have you read in any of the Follica corporate releases that the treatment relies on the usage of Minoxidil? Admins recap states an unnamed pharmaceutical compound. I think some of their very old materials mentioned Minoxidil, I might be wrong. I could care less if it does, however my guess is your statement is based on speculation you’ve read from other bro-geniuses on the internet.



  4. Michael Lazzari on November 21, 2019 at 11:19 pm

    As a diffuse thinner I think this could really be helpful in not only holding on to what we have but potentially bolster it.



  5. Greenie on November 22, 2019 at 12:48 am

    Dude must be psyched at his progress for 3 months there, not even on fin



  6. Jan on November 22, 2019 at 1:51 am

    This is a promising outcome for a 3 month treatment, though I guess they use high responder footage in their external presentations.

    It would be of interest to see more footage from the temple area.

    I also wonder if the patient shown in the above picture had any previous treatments with minoxidil only. Otherwise it is quite difficult to say if the observed effects are mainly caused by the new treatment or have to be attributed to minoxidil itself.



  7. Zed on November 22, 2019 at 4:00 am

    Will this be available in Europe?



    • Follicle Thought on November 25, 2019 at 11:16 am

      Zed, I don’t think immediately after FDA approval it will be available in Europe. It may need one more short study to become approved in Europe as well.



  8. Drago on November 22, 2019 at 4:03 am

    the result is interesting mainly for NW2-4, but it is unclear what means “5 minutes procedure” – (it will be daily, weekly, monthly, one time etc?). Also, “in-office” – perhaps it will be necessary to authorize any clinic which wants to perform this treatments. For this reason I am a little skeptical about the affordability of this treatment in the near future ( at least 2 years)



  9. Martin on November 22, 2019 at 4:22 am

    Is this result just from one in office ‘session’ and one application of their topical?
    Or is this repeated procedures and daily topical use?



    • Follicle Thought on November 25, 2019 at 11:16 am

      This is a good question Martin, Follica has not shared this particular information yet. It will be interesting to know exactly how the protocol works.



  10. Keith on November 22, 2019 at 5:34 am

    If they are posting this then it’s literally the best responding patient they have and if they have been doing this for 12 years those results are weak.

    Anybody try the C60 guy Ian Mitchell’s stuff that was just on Ben Greenfield?



  11. Armando on November 22, 2019 at 6:29 am

    Misleading images



  12. Joe on November 22, 2019 at 9:14 am

    Is it just me, or do others find it somewhat confusing that Follica and Follicum, different companies that each are developing hair loss treatment and each have proprietary molecules in their pipeline named FOL-005.

    Are they connected?



    • Follicle Thought on November 22, 2019 at 11:00 am

      It’s a bit odd that Follica chose a similar product ID as Follicum.

      Follicum’s peptide is called FOl-005

      Follica’s office/home procedure is called FOL-004



  13. Soul on November 22, 2019 at 9:56 am

    What worries me is that it can’t be done at home, because if we don’t have to depend on a center and it can be difficult to be consistent.

    The result of that image is not the first line presentation, since they indicated that it will be exposed in 2020.

    “First-line results of the fundamental study and subsequent submission of NDA to the FDA scheduled for 2020”.

    So I think it’s a previous photo and they will present better with more time of duration.



  14. Dee on November 22, 2019 at 2:26 pm

    for once photos look real same lighting etc if i had this type of regrowth id be over the moon but i really want to be over mars its promising like others keep hoping



    • Follicle Thought on November 22, 2019 at 3:46 pm

      Thanks Dee, hopefully J Hewitt can take us over mars next year 😉



      • Will on November 22, 2019 at 4:51 pm

        This is super encouraging – thanks for sharing!

        One thing I am curious to learn is whether skin disruption treatments like this can create sustainable results (with continued treatment), or it these types of results are a frenzied response to disruption and will diminish more rapidly than existing treatments (e.g. fin).

        @admin, do you know if any longer term studies exist for skin disruption (even if they aren’t specific to FOL-004)?

        Thanks again for everything you do!



        • Follicle Thought on November 22, 2019 at 7:46 pm

          Will, I don’t know of any long term skin disruption studies that do not involve other treatments. In other words, people are always using in conjunction with minoxidil or finasteride following the skin disruption treatments. You bring up a good question, I wonder if intermittent breaks from skin disruption would keep the hair growth response levels high after numerous treatments.



  15. Yoda on November 22, 2019 at 5:25 pm

    What I find encouraging about the esteemed Admin’s super duper close up pic is the reformulation of the gentleman’s “whorl” pattern on his crown. The conspiracy theorists can carp about lighting, angles, hair length, etc. but this item in particular is indisputable to me.



    • Ali on November 22, 2019 at 5:47 pm

      Very good point Yoda, I went back to take a closer look after your comment and I agree, there is no sign of the spiral in the first pic and it comes back in the after pic. Cheers to the optimistic folks and thanks for sharing this article.



  16. Soul on November 22, 2019 at 8:38 pm

    Yes, the improvement is clearly seen and if you observe you can see that the hair is born thicker and clearly with more hair. I think this treatment can improve the miniaturized hair. at least that’s what I saw in the picture. I hope we can get it to do it at home.

    But what I’m most excited about is that J Hewitt will start his first human trial in a few months!

    I also hope that HAIRCLONE will be pronounced. 2020 can lead the way!



    • JKMS on November 22, 2019 at 9:36 pm

      We are gonna make it bruh! 🙂



  17. Hairguy on November 23, 2019 at 12:32 pm

    Good results but not breakthrough worthy. The whirl at the bottom is not new hair. It’s just hair grown longer and combed over to the cover the thinning. Same for the top part of the crown. The top got combed over to the left to cover it up. Hence the new hair line of the crown on top to the right of combover. Now there is real regrowth on the middle of the combovers. He bald spot was bare naked skin. Now there is a lot of thin hairs growing in. Hopefully over a year these hairs become dark thick and healthy like the combover hairs. Maybe the 2020 top line results will show this. Either way it’s a step forward, not big step as we all hoped for but a step forward.



    • Yoda on November 23, 2019 at 5:56 pm

      Perfect, I was waiting for a flat earther that thinks the moon landing was faked to comment. Thanks for fulfilling my hopes and dreams Hairguy! 😉



    • Sam on November 23, 2019 at 6:04 pm

      The whirl does not exist in the before photo, the center of the whirl is nowhere to be found, you can’t grow hair out and comb it anyway to create that effect. Maybe the hair around the whirl enhances it a bit, but the center of the whirl came back, that looks clear to my eyes. I’m wit Yoda on this.



      • Yoda on November 23, 2019 at 10:30 pm

        Come on now Sam, sure you can…this is the freakin internet! Seriously though, until (Hair)guy(s) see an NW7 miraculously transform into an NW 1 within 10 days (or less) they will always find a pile of crap under the pony…I’m just saying. 🙁 Puretech/Follica’s money raising is regulated by the SEC, I’m sure they’d be totally down with comb overs aka misleading investors.



  18. Loser on November 23, 2019 at 5:49 pm

    @Admin you have to give us an TissUse update. The delay of the trials until January 2020 was not communicated. The delays aren’t acceptable.



    • Follicle Thought on November 23, 2019 at 6:12 pm

      I would have a hard time telling the CEO of a company who is pushing forward one of the most advanced hair therapies we’ve ever seen that the 1 month delay is unacceptable. There’s no other cloning company close to their timeline as far as we know. I just try to stay thankful that J Hewitt and TissUse are doing what they’re doing.



      • Yoda on November 23, 2019 at 10:33 pm

        I’ve said it before…Admin, you are a very patient man. If Yoda ran this blog I’d be committed to a padded cell! Joe, you’re the best! 🙂



    • Dave on November 24, 2019 at 11:56 am

      Seriously? Who are you to tell them this?



  19. Mjones on November 23, 2019 at 11:02 pm

    Yoda lol I love your comments. The world is not flat but we didn’t go to the moon lol. All jokes aside, the comb over is there. They combed the hair over. I know because I cover my temples the same way and my crown. All you need is a comb and gel to get it to stay in place. No doubt, there is regrowth in the center. Small new hairs. Yes, it’s almost 2020 and we should have a treatment that gets from nw7 to nw1. Not a treatment that works no better than the big 3. If you are happy with this advancement then you are not asking for much from these companies. They know people like you are desperate and will buy this treatment. I’m just disappointed that this will be the first new treatment to come out since Propecia in 1997 and this provides similar regrowth and more dedication than just popping a pill each morning. I’m very curious to see their 2020 topline results. It better be 100x better or else not many people will go for this when SM, Follicum will probably give similar results.



    • Yoda on November 24, 2019 at 1:54 pm

      MJ, don’t think I’ve seen you on this forum before just at that other place which will go un-named. We can agree to disagree but just a couple points…these results are at three months…have you ever had that amount of regrowth within 90 days? Typically results aren’t very visible until 6 months up until two years. I for one would give this a try, no questions. Don’t think I’d give up my current regime until it was a proven solo treatment…for me. Rome wasn’t built in a day and neither will the next generation of treatments…most likely incremental gains for a greater percentage response from a wider population of users.



      • visitor on November 24, 2019 at 4:26 pm

        I thought Mjones was a big follica fan in the past, no?



  20. CJ on November 23, 2019 at 11:21 pm

    I can see both sides of perspective that are being proposed here, but one thing I’ll say is I’d rather have this news than news that Follica dissolved their company or no news at all.

    I think people will give this fol004 a shot no matter what, even if the results from later data are just slightly better than this. But perhaps a combo with SM will work well, something to hope for at least.



  21. Jonness on November 24, 2019 at 1:10 am

    I’m not sure what people are complaining about here? This is very close to being released, and the person in the picture got a great result. The fact the treatment only takes 5-minutes means it should be cost effective. I’m happy most people don’t want to waste their time getting the treatment.. The line will be shorter for me, and since everyone who doesn’t get it will be stuck bald, I’ll end up getting all the chicks.



    • Follicle Thought on November 24, 2019 at 10:58 am

      Haha, good attitude Jonness. Thanks for commenting.



    • Yoda on November 24, 2019 at 1:55 pm

      Jonness…that’s what I’m talking about my boy! 🙂



  22. Hans on November 24, 2019 at 5:23 am

    @Folliclethought
    Have you asked Yasujiro Sugimura of Organ technologies for an interview?
    Did you contact the Japanese interviewer of Tsuji?

    We need more informations please!
    I wrote them a lot of emails. No answers except the fact that they have nothing to share in a news release now.
    They talk with an Japanese blogger about the smallest details of the treatment and commercialization but we get nothing.



    • Follicle Thought on November 24, 2019 at 11:10 am

      Hans, I did seek an interview with Organ Technologies but so far have been unable to get one. We know they are continuously working behind the scenes and will release news when they’re ready, like always. For now I notice their website is also down.



  23. John on November 24, 2019 at 6:33 am

    Well Actually when you consider how slow Hair grow the Follica results at 3 months are pretty good. Would be interesting to see results after 6 months in combination with other drugs/cosmetics like Medipost, Winlevi, Guiliani or Polichem. And there still is the Story with the Electric Stimulation Cap.



  24. mp5of9 on November 24, 2019 at 1:55 pm

    Looks very promising, as did Histogen’s phase II trial results back in 2012 : )



  25. Dave on November 24, 2019 at 1:59 pm

    Admin, you said this might be available to consumers by 2020-2021. I thought the FDA approval process takes up to 10 years with Phase 1, 2, and 3. Did you mean admission to a clinical trial?



    • Follicle Thought on November 24, 2019 at 3:36 pm

      Hi Dave, FDA can take up to ten years for companies with funding issues or similar issues like drug development, but a good treatment with funding in place should be able to get through FDA trials in 6 years.

      I mentioned the above as just some background information, as Follica is not currently in the phase 1,2,3 scenario. There are numerous FDA pathways such as 510k, cosmetic, etc and Follica’s treatment appears to following a similar route to 510k. They are showing safety and figuring out how to optimize their treatment with the current study and once the best protocol is identified they will put that forward in a ‘pivotal’ or final trial next year which will probably be 3-4 months long. This is because Follica’s treatment is based on an in-office procedure which uses a wounding device.



      • Dave on November 24, 2019 at 4:15 pm

        Oh awesome! Thanks!



  26. Mjones on November 24, 2019 at 4:49 pm

    Hi yoda, yeah I am a newbie here. Checking it out. You make a solid point my friend. I was just expecting much more from them. Just disappointed in the results. I was expecting thick dense coverage.



    • Yoda on November 24, 2019 at 5:28 pm

      Possibly with repeated treatments the density/coverage will improve. I’m not a Follica fanboy but at the very least believe they are a LEGITIMATE player in this game.



    • Follicle Thought on November 24, 2019 at 5:55 pm

      Thanks for joining Mjones



  27. Tom on November 24, 2019 at 7:46 pm

    For those of us that are bald on top the results are crap.



  28. Piotr Bednarczyk on November 25, 2019 at 4:25 am

    Hi Follicle, If the treatmet will be approved by FDA, it will be avaliable for use on Europe as well?



    • Follicle Thought on November 25, 2019 at 11:21 am

      Piotr, thanks for the question. If the treatment becomes approved by the FDA it will not be immediately available in Europe as far as I know, I think the European agency would require one more short study to have on record for themselves for the treatment to be approved in Europe. There should be something like duel-agency trials to prevent the extended delays for other continents that have to wait for treatments to cross over.



      • Lisa on November 25, 2019 at 12:14 pm

        Admin,
        Thanks for sharing the news. The results look good.

        Is this treatment tested to work only on men or has it been or will it be tested to work on women as well?

        Is it also realistic that a product that can make a structural change can receive FDA approval as quickly as one year? I would be over the moon if it does, but my understanding is if something is marketed as a “cosmeceutical” it is easily cleared to be sold, but anything that changes the structure of skin or the body requires the typical 7 to 10 year pathway. Any light you can shed on this would be great.



        • Follicle Thought on November 25, 2019 at 10:53 pm

          Hi Lisa, I believe that only men have been included thus far in Follica’s optimization study but a usual rule of thumb is that as long as the treatment is not contraindicated by affecting hormones, hair growth treatments that work for men will also work for women and sometimes women gain a little better response.

          In this case it is realistic that Follica could be approved in a year because their treatment is based around a device, in this case a wounding device, it’s not going deep into the skin and is being used topically so it does not require the 7 year route. Think of regulations around PRP, laser tattoo removal etc.



          • Lisa on November 26, 2019 at 3:09 am

            Thanks for the reply Admin.

            Sounds like the treatment is very similiar to microneedling/dermaroller followed by minox. Hope it is not the same, as we can do that now on our own, so it would not be new, just studied.



      • Tom on November 26, 2019 at 7:11 am

        No, they will probably go for FDA and EMA approval in parallel. And most drugs that are approved by the FDA are also approved by the EMA (https://www.ema.europa.eu/en/news/emafda-analysis-shows-high-degree-alignment-marketing-application-decisions-between-eu-us)



        • Follicle Thought on November 26, 2019 at 7:39 pm

          I hope this will be the case Tom, I know in some cases FDA approval does not immediately translate to the EMA. One example I can think of is Acell. Surgeons in the UK and Europe could not use Acell with PRP once it became popular in the US. We’ll see how things turn out for Follica and what they pursue.



          • vincent Williams on March 28, 2020 at 9:07 pm

            Can it be marketed after FDA?



  29. John on November 25, 2019 at 4:50 am

    Hi Admin, I saw this Study for Cosmetics using PRP analogues by Giuliani. Could you have another interview with Giuliani asking for updates for all their Pipeline? They have quite many different Cosmetics in development and it seems very possible they release something soon.

    https://www.researchgate.net/publication/335443975_Efficacy_of_a_cosmetic_product_mimicking_PRP_in_androgenetic_alopecia



  30. Jonathan Weaver on November 25, 2019 at 12:54 pm

    If they are just using minoxydil or topical finasteride whats the point of this ? You will still get sides effects and minox dont work on temples (you end up with ugly body hairs on your face as a side effect). I still don’t get the point of Follica.



    • Yoda on November 25, 2019 at 5:59 pm

      While I doubt it will just be or be at all Minoxidil and Finasteride, for the sake of argument…it will increase performance and the % range of respondents. As far as side effects…you might get them, some might get them, not everyone will get them and the factual data is the few will get them.



  31. Yoda on November 25, 2019 at 5:54 pm

    Mjones is a good poster and next to me possibly the second oldest guy on this forum! Oh, I meant wise and experienced! 🙂



  32. Mjones on November 25, 2019 at 9:04 pm

    Haha that’s right yoda. We are the OGs 🙂 I fought it’s just minox and rolling for follica. If so then that’s just sad lol. Rogaine causes me to shed bad so that’s why I put it on the safe upper area above my donor zone and make a line from hair line to crown. That area thins out but the rest of my hair on top stays somewhat dense. It’s weird. I tried adding Rogaine higher up and thinned out like crazy and I freaked out. Hait grew back after stopped applying it there. So if it’s minox all over the top of my head and needling I won’t be doing follica. Can’t risk massive shed. If it’s valprouc acid I’ll give it a shot.



  33. Yoda on November 25, 2019 at 9:58 pm

    MJ, how long did you apply Minox/shed before you quit? I know this sounds counter-intuitive but a shed is a good sign before ultimate regrowth. Also, Minox has an effect all over beyond simply the localized area where you apply it. You have to ride out the dreaded shed which can last 6 plus months. It’s tough to stomach but brighter days would be ahead. It’s always darker before the dawn!



  34. Ruchitashinde on November 26, 2019 at 1:06 am

    Hiii admin,
    I just heard from my friend that NGF-574h is available for sale. Is it true?
    Plz tell us exactly status about NGF-574h.



  35. Mattt on November 26, 2019 at 9:46 am

    Replicel press release sènt out today – Replicel still don’t know shisiedos intentions, they have recently demanded Shisiedo release the data from the trials completed this year.
    Their disagreement regarding their contract still has not been resolved.



    • Follicle Thought on November 26, 2019 at 7:40 pm

      Yes, I saw this as well Mattt, thanks for sharing. I hope Shiseido will play ball with Replicel and share the results soon. I wonder what their conversations are like, between the two companies.



      • C on November 27, 2019 at 1:49 am

        If Replicel isn’t being forthcoming regarding the results from its trials, I can’t help but suspect the results are rubbish and lacklustre. I just hope I am wrong as two left shoes on someone’s feet…lol!



        • Mattt on November 27, 2019 at 8:00 am

          It is Shisiedo that are not being forthcoming regarding the trials, not Replicel.



          • Follicle Thought on November 27, 2019 at 10:25 am

            This is correct Mattt, thanks for pointing that out. C seems to have a habit of skipping over some details. 😉



  36. Mjones on November 26, 2019 at 8:42 pm

    Yoda, the place where I currently apply Rogaine has thinned out. Corner edge of top my scalp from hairline to crown. I’ve been using it there for 4 years now. It never grew back thick. It just got healthier then diffuse after a year. The rest of my scalp has stayed the same. So Rogaine works better where I don’t directly apply it. Systematic effect works. Application location thinned out. Weird right ?



    • Dave on November 27, 2019 at 12:33 pm

      You can’t draw that conclusion. Maybe it isn’t doing anything and hair is just following its set path.



  37. Yoda on November 27, 2019 at 3:26 pm

    MJ, are you on Fin or Dut? You will thin in areas prone to thinning no matter how much Minox you use if not on an anti-androgen/DHT inhibitor. And if you are, I can tell you from experience that as you get older they loose effectiveness. Your genes are saying “hurry up and go bald already” and eventually start to overcome the fin. I was on fin successfully for 20 years before I started to thin again, made the switch to Dut a few years ago which stopped the increased hair shed. I added RU which also helped, probably not enough on it’s own, but in tandem with Dut. I’m not recommending RU to anyone as it’s an unregulated chemical, use at your own discretion.



  38. Mjones on November 27, 2019 at 7:05 pm

    Yoda – I’ve been on Propecia since 2002. I noticed ithat stopped working in 2013. My right side top of scalp started to thin. The rest was thick and normal. I felt burning and itch crawling feeling.I hopped on Rogaine which helped the itch go away and stopped shedding. Made hairs healthier again for a couple years. Shedding returned and started thinnjnv out. I bought a minox fin topical which worked wonders. Grew back density and filled on right temple. I’ve stabilize a bit but still losing density right side. Left side took a hit in 2018 Sept. Went to Europe to visit family. Came back after 3 weeks and my left side diffused out lIke overnight. The left has recovered a bit this year but not by much. I am going to agree with you that my genes are slowly taking over. Been on Propecia for 17 yrs and Rogaine foam 4 years and the minox,fin topical for 3 years. I won’t touch dut. I should use it but scared of long term effects of blocking both dht type 1 and 2. I was banking on follica but those results won’t do jack unless that pic is just a teaser for bigger improvement. I need legit thick terminal hair to fill in density.

    Do you think follica wounding will harm existing terminal hair? If it’s minox they are using then my body won’t get extra regrowth since I’ve been on it for 4 years.



    • Yoda on November 28, 2019 at 4:48 pm

      Couldn’t tell you if Follica wounding would harm existing hairs, Yoda is experienced but not all knowing! 😉 My best guess is not as it’d defeat the purpose. I think your fear of Dut may be overblown but we all have to choose the course that’s best for us. You might consider upping your dose of Propecia/Proscar. I went from 1.25mg to 2.5mg of Finasteride for a short time before my doctor agreed to write an RX for Dut. I think this was helping but wanted to go with more of a sure thing.



  39. Paul on November 27, 2019 at 8:31 pm

    Too, that patient’s hair is dark which contrasts against a light skin complexion which they say makes it harder to cover up. This looks promising for some large number of people with hairloss.



  40. peter on November 27, 2019 at 10:08 pm

    Follica has been around over 10 years and they finally release only one picture of a crown area after three months of treatment?

    Surely in all that time they must have tested this on more people for a longer time period than three months.
    I don’t know if this will be another let down or if they are holding back something great at this point.



    • Dee on November 28, 2019 at 10:56 am

      Hi Peter as I keep saying all the time whenever the BIG breakthrough really comes it will be all over the show until then it’s just hope that keeps us going I’ve been hoping for 40 years it helps to keep us focused on the bigger picture



      • Wilson on November 28, 2019 at 10:23 pm

        That’s great you’re still hoping and following the developments through 40 yrs Dee, kudos. I hope you get to see some breakthroughs in the next year or so. I want to see one of these cloning techniques come through.



  41. Mjones on November 29, 2019 at 1:34 pm

    Happy Thanksgiving yoda! Yes I take 2mg of brand name Propecia since I noticed the 1mg losing effectiveness in 2013. I bumped it up in 2014 which helped with the scalp burn and inflammation. Not much in regrowth till I added minox, and topical minox fin. I take 1mg in the morning and 1mg at night. Do you think if I take 2mg same time it will work better?

    Yeah I’m probably overthinking dut, but I did get some sides from fin, libido issues that resolved itself after 6 months. I know for a fact my derm or general doctor won’t ever give me dut.



  42. James on November 29, 2019 at 3:31 pm

    Is it worth me waiting for these treatments before trying minoxidil and derma rolling? I’ve felt with ED due to other reasons and i refuse to do anything such as fin that may cause it long term. I’m like a NW2 but with diffuse thinning on top.

    Also will this FOL-004 prevent hair loss down the line in the same way fin does? 5 min procedure you’d hope it wouldnt cost too much…

    *** sorry realised i put this in the wrong place, was up with the old comments.



  43. dwain on November 30, 2019 at 1:08 am

    just one photo is that all one photo to go by



  44. Morpheus on November 30, 2019 at 10:39 am

    Admin, did you get in touch with Dr. Takashi Tsuji?



    • Follicle Thought on November 30, 2019 at 3:12 pm

      Morpheus, I haven’t been able to get in touch with Dr. Tsuji for a while. He is intentionally quiet because his technology is so valuable. Typically, the Organ Technologies company sticks to press releases to divulge news now. One thing is certain though, the company is busy behind the scenes preparing their technology for human application. That’s all they could be doing at the moment.



  45. Someone on November 30, 2019 at 11:24 am


    • Follicle Thought on November 30, 2019 at 3:14 pm

      Hi Someone, I did an article about this earlier this month https://folliclethought.com/allergan-invests-25-million-into-new-hair-loss-drugs/ I think it’s awesome and these new treatments from Exicure/Allergan could be highly efficient “targeted” therapy for androgenic alopecia.

      Amazing effort by Allergan to invest in these new RNA therapies, Stemson, and Pelage pharma. They want to win from all angles. Now, we just hope they pick up HSC from Histogen and get it going immediately.



      • John on December 1, 2019 at 3:30 pm

        Hi Admin, Histogen Shows CCM Cosmetics as Marketed with Allergan since few months. If its really true that Cosmetics are quicker at market we should get something soon.



  46. Someone on November 30, 2019 at 5:12 pm

    @FollicleThought I am not too much into science. What is about this Exicure technology and how it is connected with androgenic alopecia?



    • Martin on December 1, 2019 at 3:00 am

      It will be long time until this is available.
      You’ll have plenty of time to research what it’s about.



    • Follicle Thought on December 1, 2019 at 3:54 pm

      Someone, I’ll do my best to describe what I know of the technology. The Exicure SNA technology, which stands for spherical nucleic acid, delivers DNA or RNA molecules into tissue topically. It’s basically a way to temporarily edit the genetic expression of an organ, changing the genetic expression gives you the ability to adjust the immunity of an organ and other strengths and weaknesses. So, in plain terms they could theoretically adjust sensitivity to DHT, inflammation, or manipulate stem cell cycling. The sky is the limit, it just depends on what type of approach/target they are going for.



  47. Yue on December 12, 2019 at 4:03 am

    So many years have passed,follica kept putting it off,Everyone was disappointed!When else can it cheat everyone?



  48. Yoda on December 19, 2019 at 6:01 pm

    Put your near term faith here (Follica), cloning, stem cell and the like are many years away from being accessible, affordable treatments for most. Just my opinion, not a fact.



  49. Will on December 19, 2019 at 10:19 pm

    This seems like a BIG update. Thanks for sharing admin! It may not be the holy grail, but this certainly seems like it could be a major help to many of us until a final solution arrives.



  50. Micah on December 20, 2019 at 1:43 am

    Geeeeeze, I guess if you’re in your 50s you might as well freaking forget it!!!!!!!!



    • Follicle Thought on December 20, 2019 at 12:59 pm

      There’s other companies for people in their 50s Micah. Hopefully Tissuse, Stemson, Tsuji or similar can help you.



      • Yoda on December 20, 2019 at 1:31 pm

        In regards to my comment about being 57, with all due respect Admin the companies that you’ve identified are not ones I’d not hang my hopes on. Particularly Tsuji and Stemson, these are a ways off if they are even ever proven to work.



        • Follicle Thought on December 20, 2019 at 1:41 pm

          I hear ya Yoda, my comment was moreso intended to mention potential options to Micah, not necessarily options to hold hopes on. His comment implied that he’s in his 50s (maybe indicating a degree of hair loss) and that Follica would be inefficient for his needs. So I simply presented companies who aim to treat more advanced degrees of hair loss. The only other option is to give up and like you said most of us don’t want to and down the road we are still looking for options.



          • Yoda on December 20, 2019 at 3:04 pm

            Gotcha Admin…being in my 50’s I took Micah’s comment to mean that if things take so long what good would it do for us Boomers/old dudes. I think Follica, Cassopiea and Samumed are the closest potential treatments to hit the market to be more effective than what’s available today. More treatments are sure to follow with an even greater degree of effectivity, it’s just a question of when.



    • Yoda on December 20, 2019 at 1:28 pm

      I’m 57 Bro, you never forget it! 🙂



  51. Jonness on December 20, 2019 at 3:21 am

    Wow, 44% improvement (NW3 and NW4) with Follica vs 12% improvement with minoxidil/finasteride. Phase 3 starts in 2020. Incredibly good news!



  52. pjotre on December 20, 2019 at 11:22 am

    Hm i red the same article on hair 2020, why?, work together admins, so we have one point to discus the topic. I think it’s also better for advertising income.



    • Follicle Thought on December 20, 2019 at 12:48 pm

      There’s always going to be news that multiple websites cover, just wait a week or two this news will show up on Youtube by the vloggers who follow the blogs.



  53. Kster on December 20, 2019 at 12:10 pm

    Would the Phase 3 Trial be three months long also? Just thinking about possible market release.



    • Follicle Thought on December 20, 2019 at 12:47 pm

      It is possible that the phase 3 trial could be 3 months long, however, the duration for the phase 3 has not been specified yet. My estimation is that the trial will be between 3-6 months long.



  54. John on December 21, 2019 at 9:37 am

    Does this actually explain why Botox may help in Hair Loss? …

    “Our major discovery is a previously unknown smooth muscle that surrounds hair follicles and is called the dermal sheath,” explained lead researcher Dr. Michael Rendl. He’s associate director of the Black Family Stem Cell Institute at the Icahn School of Medicine at Mount Sinai, in New York City.

    https://www.upi.com/Health_News/2019/12/19/Hair-growth-finding-could-make-baldness-optional/2841576785436/?sl=2



    • Ben on December 21, 2019 at 10:25 am

      Dr. Michael Rendl is also a scientific advisor to Stemson/Terskikh.

      Interesting find, looks like they got a lot of important information on the plate.



  55. DragC on December 22, 2019 at 1:33 am

    Admin, even in Berlin is happens new things
    https://www.youtube.com/watch?v=iAS_k1IrJpA



    • Big L on December 22, 2019 at 6:54 pm

      Is this similar to Tissuse’s SHT method? I thought I remembered hearing at some point that German scientists published a paper about neo-papillae forming new hair follicles for SHT in 2011, which is when this video is from. It seems like what this video shows is essentially the same idea as that. And from the video, it appears to work. They speak about it in the video like they have it all figured out, I don’t understand why 8 years later we don’t have the technology yet.



      • Mattt on December 23, 2019 at 10:05 am

        This is Tissuse, Dr. Uwe Marx is the founder of Tissuse and Dr. Ronald Lauster is on the advisory board.



      • Follicle Thought on December 23, 2019 at 11:17 am

        Big L, the scientists in the video posted by DragC are in fact the scientists from TissUse. It’s the same method. Mostly funding is the reason why it took 8 years to find out if the technology worked.



        • Big L on December 24, 2019 at 8:32 am

          Mattt and Admin,

          Thanks for clarifying. I think this plus a transplant will be the closest thing to a cure to an NW2-NW4 for now, when it is available. Let’s hope it’s sooner rather than later.



  56. Stephen on December 22, 2019 at 4:43 pm

    It appears they are using minoxidil and possibly one other substance after skin disruption. I highly doubt this can’t be replicated at home once the protocol is known.



  57. Yoda on December 23, 2019 at 4:36 pm

    And I highly doubt the skin disruption is simple micro needling, in turn I agree with Stephen that this won’t be replicated at home with similar results. It never ceases to amaze me some of the conclusions people jump to. 🙁



    • Follicle Thought on December 26, 2019 at 7:09 pm

      Hopefully Follica’s device really does have some improved tech to it! I do also understand how people can jump to conclusions too, we only get to deal with a limited amount of info from the companies and misinterpretations do arise. Of course, the hope is high that Follica’s in office procedure will be advantageous.



  58. Tom on December 24, 2019 at 6:19 am

    Admin, do you think there is a chance that Samumeds drug + follica’s could be a great combination? They should collaborate..



    • Follicle Thought on December 26, 2019 at 7:01 pm

      I think there is a chance for some synergy between SM04554 and Follica. The SM molecule stimulates the Wnt pathway, and we know that Wnt is involved in hair regeneration and the wounding process. So, it’s theoretical for now but if minoxidil works well with microneedling I don’t see why a Wnt molecule wouldn’t pair well with wounding also.



  59. Josie on December 11, 2021 at 1:19 pm

    Where do things currently stand on this treatment? Are you any closer to a release of this product? How will it be marketed? Are you looking for test volunteers?



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