This morning, Follica announced positive interim data in its Phase II clinical trials. They are now on track to start pivotal trials at the end of 2019, which I discussed a month ago. In this latest press release, they have some interesting quotes from Dr. Ken Washenik and Dr. Rox Anderson.
One of Follica’s well known clinical advisers, Dr. Dhaval Bhanusali, has kindly agreed to answer reader questions! We have been going back and forth about this for a few weeks, but it seems he is now ready after this latest news has become official.
I think that this is the first time that I have had success with anyone important on Follica’s team responding in person. Dr. Bhanusali works with various celebrities (e.g., Martha Stewart) and even starred in a Men’s Health article.
Readers on this blog have at various times posted links to Dr. Bhanusali’s Instagram and Twitter accounts.
Dr. Bhanusali told me the following:
“There are lots of things I can’t say because of NDAs and also legally because companies like Follica have investment partners that are publicly traded (so legally, not allowed to, even if I want to). But happy to talk in generalities at some point and genuine thoughts on things!
I haven’t kept up as much as I should have on hairloss websites, but I think the internet is unfortunately full of companies that take advantage of patients/consumers with false claims and it is super sad. Happy to help if you think I can educate on things that help patients long term.”
So please keep the above in mind when asking your questions in the comments to this post.
Thanks for taking question Dr. Bhanusali! In the clinical trials, was the same level of efficacy of the treatment witnessed in individuals with a Norwood scale greater than IV? Also- what factor did age play? Thanks
This is great! I’m still very curious if Follica and Aclaris are working together but they seem to be neck in neck. My questions are:
1) Will the new hair grow in a normal-looking pattern and will the hairline look natural?
2) Does hair grown in with normal pigmentation or if you’re partially gray or white will it match with your current color?
3) How long does it take to regrow full head of hair if mostly bald to start with?
4) What do you anticipate will be the cost of full treatment?
Dr. Bhanusali I was was hoping you are allowed to give a presumption on whether or not you believe Follica will come to market by 2020?
How long will the phase 3 trials be?
How long before this hits the market?
With reference to “achieved a visible and statistically significant improvement in non-vellus (visible) hair count”, was this visible improvement in the form seeing pre-existing hair appearing thicker, or were you able to generate new hairs in places previously bald?
I ask this because the next step involves “up to 60 men, ages 18-40, with moderate grades of androgenetic alopecia (Hamilton Norwood III-IV)” and not people who are Norwood 6 or 7.
1. Will there be ongoing daily, weekly, monthly, yearly maintenance required? If so, in what form and how often?
2. If ongoing maintenance is required, will the new hair be lost?
3. How many treatments are necessary to achieve maximum effectiveness and are the results permanent?
Will women with FPHL benefit from the treatment too? Thanks in advance.
1. After updating the website http://www.follicabio.com, the second device and the smartphone disappeared from there, what does this mean?
2. Will the doctor be treated only?
3. In which countries will follica be available?
4. Why so long? almost 20 years
5. Do you think this is the best treatment for AGA?
Do scientists in the field give any consideration to the fact that young men are gambling with their hormones to save their mental health? Are they aware of how this makes us suicidal?
Hello Dr. Bhanusali,
Given your knowledge of the field, in what year would you expect a NWIV+ to be able to walk into a clinic and pay for a treatment that will restore normal hair growth?
1 — In which areas of the scalp are patients most likely to see improvements? (Another way: Does this method address both crown and front temple hairline loss effectively?)
2 — Are new hairs created with immunity to AA or does it fall out and revert to its previous state once the treatment is stopped?
3 — Do you have a release scenario? (i.e. Will it start in larger cities across North America (LA, New York, Boston, Toronto, Vancouver, etc). Will the topical be sold not only on Follica’s website but also places like Amazon and Walmart?
4 — Will the topical require a prescription?
5 — Do you believe Follica can replace The Big Three™ (Minoxidil, Finasteride, Ketoconazole) as an effective one-stop treatment?
My questions have already been asked by other users, so I’ll just use this opportunity to thank you for your work, Dr. Bhanusali. And thank you for taking time from your busy schedule to answer our questions. So very much appreciated.
Best wishes and greatest of luck, Dr. Bhanusali.
off topic question:
If somebody was born with a shitty hairline, these regrow treatments won´t help him fix / lower his hairline right ?
What potential treatment in the pipeline would tackle such a problem ? or would a hair transplant still be the only solution with that long recovery process / red dots / stress hair loss …
Thanks!
Long live the admin!!!
Long Live Cots! The king of hair loss! Long Live the Admin for putting up with my drama haha . Have you noticed that every time I complain a new breakthrough news statement comes out. I just realized that lol.
Lol! Probably true, since you complain once a month.
Hahaha I should complain more often. We would have a cure by now if I did it daily lol
Keep it coming dude!
Can you please complain about Shiseido and Tsuji? And even genetic editing?
Thanks,
-God
lol
What is the target timeline for follica release in european countries?
Will follica work for guys that have performed FUE transplant on hairline but have further progression of hairloss after the transplant?
Thank you
Question 1: You mention dishonest companies making false claims. Is there a broader problem with the steady stream of published peer-reviewed research that makes claims about hair-growth promotion (in mice, or ex vivo, etc.) from various neutraceuticals, cosmetic compounds, and extracts from plants used in pre-modern herbal medicinal traditions? Many – if not most – of these compounds are already available on the market, and seem awfully alluring to we, the desperate and balding. Are conflicts of interest amongst researchers part of the disinformation and confusion about hairloss treatments?
Question 2: Will the follica treatment hurt? What about topical numbing agents? Is there a potential for scalp infections that would make an at-home device problematic for the company?
Main question: If new hair follicles are created, will they not just continue to fall out because of AGA??. ie. there’s nothing making them immune to DHT is there?
Dr. Bhanusali,
Does the micro dermabrasion process require the patient to shave their head? In other words, will it damage existing hair?
Have you tested whether the treatment can be repeated, for example 2-3 times per year, to compound the results, and if not yet tested, do you have an opinion about whether the results can compounded?
Do you believe that FDA approval will move relatively quickly if, as most assume, the compound is already FDA approved?
Thank You
1. Is there a distinction between dermabrasion and microneedling?
2. Is the process repeatable?
Thanks!
Will there be clinical trials for women? What are your thoughts of hair supplements like nutrafol and viviscal?
I recently read Dhurat’s paper, and numerous users have tried this method; What is your take on derma pen/ derma rolling your scalp with a length of 1.5mm-2mm? Can it help regrow hair? Especially with minoxidil?
You might have better information than us, so how long will we wait before having a “head full of hair” treatment released? Thank you
Can you ask why there is no mention or submission about their trials on the U.S. National Library of Medicine Clinical Trials website: https://clinicaltrials.gov/
A couple of other interesting pieces of information I saw this morning: 1) PureTech has increased its equity stake in Follica to 77.9% (now updated on the Puretech web site……they previously held a 62% stake…..you would think a telling indicator of their confidence in the treatment. 2) From Daphne Zohar “The interim analysis showed a robust response to Follica’s proprietary treatment”. “Robust” sounds promising and comparatively significant to me.
https://www.morningstar.co.uk/uk/news/AN_1560435556291660600/positive-results-from-puretech-affiliate-male-pattern-hair-loss-study.aspx
Admin, I’m wondering if the trial recruitment for a 12 Week trial you discovered on SkinCare Physicians website wasn’t the one referred to in this new release when they say, referring to the optimization study: “The study will continue to enroll up to 60 men, ages 18-40, with moderate grades of androgenetic alopecia (Hamilton Norwood III-IV).” It sounds like there will be continued optimization studies in addition to the pivotal study.
Thanks Pinotq. Puretech increasing it’s stake in Follica is very good news. I hope Dr. Bhanusali can elaborate on the SkinCare Physicians trial.
On a related topic many have lost faith in Aclaris. But remember their study is on very bald people and maybe it just takes more time for hair to get thick again. We will know very, very soon could be any day now.
Keep on truckin nasa_rs! :-)
Yeah let’s pray for immune suppressing drugs to grow back our hair. That is the ultimate cure lol. No offense nasa but I don’t see the fda approving this even as a topical. Riken and siseheido would be better safer options
@Mjones Same is true for kidneys and livers and other organs tsuji and others will regenerate in the future.
If they find a compound that works to regrow all a person’s hair how long do you think it will take to appear on the Black Market? All my opinion.
A day! Maybe take the unsafe drug to get the hair back, then stop the drug and then take finasteride to maintain it
-Will follica’s new treatment require the use of minoxidil or can it be effective without it?
-you recently made a post online about playing with a new hair growth liquid or compound etc (new blond baby hairs). Were you referring to follicas compound or is this something different? And of it is not related to follica, when can the public have access?
Can micro-needling be a possible maintenance treatment? Would a person be able to maintain the hair they have if they maintained a specific regimen i.e. abrasion induced neogenesis?
Also, how deep will the follica treatment be? Needling/skin disruption wise?
Hello all! Thanks for taking the time to write in questions and looking forward to answering this weekend. Will try my best to help = )
A few quick things about me- will do my best to answer questions- as mentioned above- some I can, some I unfortunately can’t. My work/research has varied from traumatic scar treatments to drug and skincare development, as well as hair of course = )
In the hair world, I’ve served as consulting dermatologist for Rogaine and now do most of my work with the development side of a project called Hairstim, as well as a clinical advisor at Follica
Thx you Docter, well I hope that you can and may give an answer to most the important questions, namely: 1.) is Folica a product which gives a much better result than the already existing ones such as minox, 2.) is it safe, and 3.) When will it be on the market for sale?
Looked through some of the initial questions and figured I’d clarify- The Follica announcement essentially means the initial studies went well and now they are moving to pivotal trials. In order to get clearance to come to market as a medical device, you need to first prove the science (done a while ago) and then animal studies. As the press release stated, this was the first of human studies and it went well (specifics I have to defer to the exec team to release if they are able to). The hardest part of developing medical devices is understanding how to optimize results (how deep do you go? How often? how many times?). At the end of the day, you want to make sure you are creating something that optimizes results not something that provides marginal improvement. Additionally, you want things to be reproducible and consistent
One of my concerns with PRP is that it isn’t as consistent as we’d hope it to be- 20% of people don’t get a great result (In my experience, very subjectively and not scientifically, it’s been more in my female asian and south asian patients)… there is a subgroup that gets a “rip” with 40-50% improvement fast.. others take months to see improvement..others up to a year. It’s variable patient to patient and in all honesty, it’s not ideal. These are convos I have with my own patients- you have to be up front and honest- these procedures can be expensive and if you try to force things on people, you are being a salesman, not a doctor. Good dialogue is key to a good relationship and need to present the facts before deciding how to proceed.
Some above have asked about microneedling- In my opinion and with my patients, it has helped but again, the main issue is that the consistency isn’t there (which is why the Follica work is important and why it takes so long to figure out parameters on any device, etc. note- not implying the Follica study is simply a microneedling device). The Dhurant study was a great example of benefit. For at home- it’s tough- I think you need to go father than 0.5mm and I’m not sure they legally sell those and if they do, we worry about infections that occur when you go deep and dont adequately clean the devices (have seen this in the office a few times)
Re: follica’s timeline- honestly, those those things tend be more dependent on the regulatory bodies than the company- all depends on how/ if things approved- if they request more information, more studies, etc.
Re: Aclaris- I know they are working on Jak inhibitors- I’ve seen INCREDIBLE results with Jak inhibitors with Alopecia areata (an autoimmune hairless disorder) that I treat often (and personally have). I dont know how the studies have panned out with androgenic alopecia but I know Dr. Walker well (CEO of Aclaris and really great guy) and I am genuinely rooting for them. I think the biggest misconception is that everyone is in competition. In all honesty, as a doctor, I hope everyone succeeds. I dont think hairloss is a simple as a “one size fits all” which is why certain things work for some people and not for others. anyone who tells you “this this and this will only work” is not being truthful. When cancer therapeutics were in infant stages, they were just doing chemo to destroy everything in the area of the tumor. It wasn’t until recently they realized each cancer has specific mutations and unique pathways that need to be targeted on a person to person basis. There’s a reason that minoxidil works amazing for the crown but not as much for the frontal aspect of the scalp and why finestaride is better for that area. Diff pathways, different signaling, etc.
Thanks Doctor. I was hoping you could let us know if you think those of us who have had a few hair transplants will be able to effectively use Follica. Thank you for your time.
Hi Dr. Bhanusali,
Per wikipedia, “Pivotal Trials” can mean Phase III or Phase II.
https://en.wikipedia.org/wiki/Pivotal_trial
Adding to the confusion, we often see Phase IIa and Phase IIb as separate trials in many (or all?) instances of new drug development.
Follica’s product will use existing compounds, at least initially. So does the mean trials can proceed faster than typical new drug development trials? Or does the addition of wounding change this assumption?
Also, in the below post, I mention recruitment for a trial by SkinCare Associates:
https://www.hairlosscure2020.com/follica-pivotal-trial-in-2019/
Do you know if that was recruitment for still-to-come pivotal trials, or for trials that have now already ended?
Finally, in Japan, trials can now proceed much faster than in the US. For a product such as Follica, you can probably even skip Phase III trials entirely per new regulations. Has Follica ever considered clinical trials in Japan?
Thanks a lot for your time.
Re: recruitment- I dont know exacts on recruitment for the pivotal at the moment but most generally tend to go with patients they know/ current patients. It’s hard opening it up to larger groups given the worry that people can detail information online (like here = ) ), etc. and then the company can face backlash from the FDA and even get rejected because of it. Again, I say this in the most honest way possible and this goes for all trials from all companies- sometimes the reason people cant share information is not that they dont want to ..they just legally cant
Is there any hope for my diffuse thinning? :(
Re: some of my instagram posts (the blonde hair regrowth referenced above)- We’ve been using a compounded formula through a platform called Hairstim. I helped with the development side and it was in response to a few things. One, we wanted to find a way to get SAFE versions of topical finestaride, topical spironolactone (female),topical high dose minoxidil, topical retinoic acid, high-dose minoxidil (6% and above) etc. I’ve seen patients obtain some of these via eBay and foreign countries and have worrisome results/ reactions. We then started playing with different mixes to help with tolerability and further block DHT, etc. The platform will likely “officially” launch in the coming weeks but Dermatologists around the country have been using over the last 6 months or so (few thousand patients) with great results. Again, not a one-size-fits-all by any means (important to always be honest) but a great option for those who are failing the generic minoxidil 5% / oral finestardie combos. Of note, we are getting more and more worried about oral finestaride side effects (seeing these more often in the office) which is why the topical version has been appealing. The main point would be to see a board-certified dermatologist. Message boards are great and I love the sense of community, but it’s good to also see someone who treats this daily. If you need suggestions, happy to send references of Derms I trust
Of note, we are getting more and more worried about oral finestaride side effects (seeing these more often in the office) which is why the topical version has been appealing.
In what sense?
Re: nutrafol and Viviscal- I dont generally recommend them to patients as I haven’t seen the results promised. That being said, can supplements help? Absolutely (I rec 5000U vitamin D daily and others) but I think for the price point and lack of non-sponsored evidence, I dont want my patients to pay a ton for marginal improvement. I’ve actually been trying to crowd source an “ideal” supplement from my colleagues and evidence but still a ways from doing it. I also think most shampoos that are OTC are unfortunately not effective either. I like Ketoconazole (RX) as there is evidence behind it and generally rec for patients who want to maximize all avenues but again, not first line.
I want you to answer my question above please. In short, is this purely a maintenance product whereby anyone beyond a Norwood 5 is a lost cause, or did your results grow hair, no matter how little, in areas previously bald?
Anyway, I hope this has been helpful! The internet can be a crazy place but I hope that you see that researchers are on your side and while it may be frustrating that things move slow, they are trying their best to get things to patients with safety and efficacy as the priorities = )
Dear Dr. Bhanusali,
I know this is a bit off topic but what’s you’re take on Shiseido / Replicel and Dr. Tsuji RIKEN hair cloning?
Thank you.
Has the topical already been cleared for use by the FDA? Does this speed things up? Is the final trial just for optimising the treatment?
Hello Doctor. Your Hairstim product sounds appealing. Is it similar to 82M and 82F compound minoxidil that has been on the market the past few years? It sounds like it’s the same ingredients. Will hairstim be more effective ? I have been using Propecia for over 15 years and Rogaine for about 6. The effectiveness for both have waned and need something to boost regrowth as I have been declining in hair density the past 5 years.
Mjones, he indicated higher strength minoxidil, Formula 82M that Bauman is peddling is only 5% minoxidil. I have years of experience with this, have tried most all. Minoxidil is dose dependent (credit Dr. Richard Lee), higher strength 15%, will be the key. The other goodies in the formula can help as well. Besides the concentration, the ability to penetrate is very important. Hopefully it’s a liquid, easier to use than creams and lotion, and in my opinion penetrates better. I’m interested in this, hopefully a real deal Xandrox replacement after all these years. Seems like Follica is going to be a few years (2-3+) out, unless I’m missing something?
@Yoda is there a way to get your hands on 15% minoxidil for now? Before all the cell therapies come out?
Dr. Bhanusali.
Can you suggest/reccomend any Dermatologists in NY please.
“As the press release stated, this was the first of human studies…” <— This quote has given me a sinking feeling as it seems to suggest they are still in the early stages, perhaps, I’m afraid, the ole’ **5 years** away bit and not anywhere near admin’s 2020 prophecy.
Toccata, that’s the way I read Dr. Bhanusali’s answer as well, I thought they were much farther along than that! If our take is correct, Follica is years away. Dr. Bhanusali do you care to clarify?
Yoda, if Shiseido and Tsuji are coming in the next year / two years then what will it matter? I understand not everyone has the funds for the permanent solution but in a few years even the price of those will drop.
Your’e positive that Shiseido and Tsuji will be out and accessible within two years? I’m not, and I’m not being negative nor is cost an issue. No one has a crystal ball, maybe they will and maybe they won’t. Why not hedge your bet with the best current treatments available until these “holy grail” treatments are readily, commercially available. That’s what I’ve been doing for over 35 years.
Although I do understand that these are two different markets and that people may be looking for a different type of treatment.
I’m not going to read much of anything into Dr. Bhanusali’s comments. He hasn’t really answered 1 question about Follica so far. My guess is that he is not allowed to. There’s more talk about Hairstim than Follica. Compare what Dr. Bhanusali said about “first of human studies” to this quote from Jason Bhardwaj, chief executive officer of Follica, 3 days ago, emphasizing YEARS of testing: “From years of clinical testing, we have optimized the dosing, frequency, and several other important parameters and translated these learnings into a unique and proprietary treatment. Based on this interim analysis and the results of three previously conducted studies, we are excited to move forward into a pivotal study at the end of 2019.” Note that the timeline on the Puretech website says “PHASE 3/PIVOTAL”, at least some indication that these are one in the same. Also note these factors: 1) Follica has been as tight lipped as any potential player in the hair loss industry until now; 2) Puretech has recently purchased a greater equity stake in Follica; and Puretech’s stock price (Follica being only 1 of many Puretech ventures) is up on this news. I read much more into those factors than anything I have read here.
Dr Bhanusali,
Can I come to your office to get into Follica trail?
I don’t need to know the secrets about it just the treatment that I want, if will cost me something let me know
@toccata, I feel the same. Depressing.
I dont think he necessarily said thought that the next trial isnt the last one. Pivotal to me means last.
I want my hair back.
I do not want to wait Years.
I just want to look like the way I did before.
I just want my hair back.
Admin, can you get more info on this Haitstim thing the doctor was talking about?
Is it going to be released worldwide or in select dermatologist offices? Not a lot of info available for a product that supposedly coming out in weeks.
Just found this
http://www.hairmedicinals.com/
Looks like the hairstim website. And of course, they dont deliver to Texas which is where i am at, so FML.
Can anyone else get ahold of this formula?
I hope this post does not become about Hairstim:-(
I think that’s exactly what this is……………….a soft sell for Hairstim.
Sure looks like it.
Admin, I respectfully request that you consider doing a post about Hairstim. If it can seriously be a Xandox replacement/equivalent or better then it will be a good treatment until the next gens are actually commercially available.
Regrettably, this has left me feeling apprehensive. I personally don’t want to use 5-ar inhibition in my regimen due to previous bad experiences. If Follica includes 5-ar inhibs, it’s not for me. Unfortunately. Extremely unfortunately.
He could have answered my question without getting into trouble, but didn’t.
If you want to write a PHD you get marked down if you write it like a novel, using phrases like “visible and statistically significant improvement” and “positive interim data”. A qualified researcher would instead put 5% above baseline in 30% of cases.
I actually feel less confident in follica and there current status now after reading his responses. I do however appreciate Dr. B communicating with us, and admin getting him involved. Good work admin, way to be proactive.
Admin, I think this is going to be a soft sell for Hairstim.
Yoda- I wish Dr. Lee didn’t get shutdown. I definitely could have benefit from it now. My hair was stabilized and thick in 2000s with Propecia. I am going try 82M or 82F or this Hairstim. I like how the FDA shutdown Dr. Lee haha so obvious Rogaine was behind that to eliminate their competition. I heard Dr Lee formula was awesome and tons of people regrew a lot of hair. He must have been a nice man too. It’s the good guys that get shutdown.
Mjones, I tried 82M (82 F wasn’t available at the time) within a year or so after Dr. Lee got shut down. Didn’t do much for me, the concentration is only 5%, I need higher octane. Don;t become one of the conspiracy theorists on here…Dr. Lee did not get shut down by Roagaine. Some prick black mailed him for $20K as he was dispensing finasteride over the internet without a consultation. Lee paid him, the guy tried to extort more money, Lee said no and the prick turned him into the FDA who shout him down. I hope that prick burns in hell!! (admin, can I say “hell’ on here?) :-)
Few things I was asked to clarify- Re: studies- in general, there are differences in proof of concept studies, validation studies and the actual studies needed to get things approved. Again, I’d love to share the specifics of each of them but some things I am unable to do so. Genuine apologies for that
– Re: Hairstim- just providing info on some of the work that we do = ) At the end of the day, most of my work (Hairstim, skin medicinals, etc) tends to focus on creating better access and safe solutions for patients (and also creating contributions to non-profits that fight on behalf of patients). The ingredients are significantly different than 82M and some of those others but given the context of this Q and A, didn’t want to expand on that unless admin had requested.
My main recommendation is please be careful of obtaining things on eBay, Alibaba , or wherever that may cause more harm than good. We are unfortunately seeing more and more of this in our offices. Re: the length many of these companies take to get approved- the process takes a while and can be frustrating (for both you and the companies) but we will continue to work hard and push on all fronts. It’s a privilege to work on behalf of our patients and we hope to make you all proud
@DrBhanusali I think the point below is a good one. Why not look here for participants? You would have loads of people sign up quickly. To be honest when you look at some trials (eg Samumed) you cant work out why they take so long to get up to total numbers of participants. How can it take months to find men willing to try a baldness cure?
Dr. B, you may want to advertise upcoming trials on here to speed things up. You would have an abundance of participants. Please consider.
Well, it was nice of him to talk with us and I do appreciate his time but it’s clear he’s not permitted to discuss the things we’re most interested in in detail. Back to the waiting game…
Unfortunately I have not learned much about your answers, but thank you nonetheless, doctor.
Man that guy didn’t really answer one question we cared about lol
Thanks admin for being a beast at what you do. You’re the real MVP here
Thanks “Itchy”. I was hoping for more info on the trials, but I guess Dr. Bhanusali can not divulge almost anything :-(
Hear, hear!
DrBhanusali,
Off topic, but can you please explain why i cannot get Hairstim in Texas? Will it ever be available here?
Thank you
Does this process work on the temples and hairline?
Is it repeatable?
Does it require multiple sessions of wounding?
What is a realistic release window in the wake of a successful pivotal trial?
Will you treat patients from Canada or other countries? I.e., will or can you ship the at-home materials and device internationally?
Is it 100 terminal hairs per square cm or vellous?
Is it going to be available to buy this or next year?
Whats the price?
Will this cause initial shedding? Any reports of initial due to the minoxidil? Can patient opt out of minoxidil and use only the other ingredients?