Follica Announces Phase 3 Trial Design In 2020
We have yet another company moving towards a pivotal trial for hair regrowth in 2020.
On June 4, 2020, Follica issued a press release to announce a positive ‘end of phase 2 meeting’ with the US FDA in preparation to begin a phase 3 trial this year. The release also outlines details of Follica’s phase 3 trial planned for later this year:
- ~280 patients will be enrolled. The release does not mention gender specificity.
- Primary endpoints are: terminal (visible) hair count and patient reported outcomes.
- Trial will be randomized, controlled, and double-blinded.
- Follica will also conduct a pharmacokinetics study alongside this trial. This is interesting and may alude to the fact that there is more than minoxidil being utilized in this treatment?
PureTech Health Presentation: Follica FOL-004 Trial Data In December 2019
Hair Follicle Neogenesis (HFN) Device
Follica’s proprietary device which is designed to create minor skin disruptions in order to stimulate the growth of new hair follicles and new hair is officially called the “HFN” or Hair Follicle Neogenesis Device. Interestingly, the press release mentions that “Follica’s approach is based on generating an ’embryonic window’ in adult scalp cells via a series of short office-based treatments with its proprietary (HFN) device.“
This is the first time we have learned that Follica’s treatment approach will include multiple visits to the clinic for treatments. Previously, the company has mentioned that the in-office portions of their treatment regimen only take a few minutes to be completed. As of now, a time period for the initiation of Follica’s pivotal phase 3 trial has not been announced, though, we can likely expect it to take place around Q3 2020.
What does the audience think of the pharmacokinetics study being carried out and the announcement of multiple office visits? You can share your feedback in the comments section.
Posted in Follica
Is this anything more than dermarolling with minoxidil?
That’s unanswered for now but the fact they are doing pharmacokinetics study is interesting. If only minoxidil was being applied there would likely be no reason to do such a study. But we will find out soon enough.
A pharmacokinetics study is relevant when it concerns the fate of a chemical involved in a new medical treatment. Even though Minoxidil has been studied rigorously and specific concentrations are approved by the FDA for topical application, Follica’s procedure appears to include the application of drugs to epidermal tissue that has not yet had the opportunity to fully heal. This warrants investigation because the application of Minoxidil immediately following a wounding procedure exposes the patient to the risk of Minoxidil entering the bloodstream, the side effects of which have been observed and can be serious. Please do not attempt to replicate Follica’s procedure at home (without medical supervision), especially since the full details of their trials have not yet been released. I know you want to save your hair and that losing it can be a psychologically distressing experience, but please don’t expose yourself to risks we don’t yet completely understand. Take care, always.
Appreciate the feedback about pharmaco, but no one has been advocating to replicate Follica’s procedure at home. However, there are literally thousands of people doing microneedling + minoxidil at home already. Not to mention patients who are taking doctor prescribed oral minoxidil for their hair loss, which of course goes directly into the bloodstream. Take care as well.
Can you tell us anything about keralase or kerafactor which is a serum that is stronger than PRP for hair without having to do a blood draw?
I will look into this when I have a moment, Jessica. At first glance it sounds like a marketing bit. If a product were truly more effective than PRP without doing a blood draw the company would likely have been smart enough to conduct a controlled study and publish results. So, it’s unlikely to be true but still possible.
Follica had so much promise years ago. I thought they said an in office scalp abrasion visit would be the start of treatment and then we would do our own abrasion with a take home device and topical. I also thought they were in phase 3 some time ago.
All of these companies going into trials is good news but the real question is if some of the cloning treatments will join the party.
That’s good news Admin. However the have not announced exact dates about the duration of phase e. Is that correct? Cheers Admin!
Yes that’s correct.
I read some of the comments on here and scratch my gray haired head. Come on, this is a treatment going into phase three!!! Who cares how long it took to get there, as long as they get there. And who cares about cell based coning treatments until they actually go into clinical trials, when they do I’ll start to be more interested. Samumed, Histogen, Follica maybe some others are what Yoda has his eye on, these are the best shot of being released in the next few years….They’re IN CLINICAL TRIALS!
What does the audience think of the pharmacokinetics study being carried out and the announcement of multiple office visits? If it works, is released and can improve or replace my current regime Yoda is in!
No worries Yoda. When these comments happen try not to let it get to ya. We’re still free to enjoy the good news. The hair growth industry is making moves of late and I have to believe that Histogen has inspired other companies to keep up the pace.
Follica, SM will be the new mpb treatments for 2020s . I agree with yoda. Why focus on cloning when it’s not even in clinical trials. These treatments are in phase 3. Let’s focus on that.
The first trial for cloning will be major news and could happen at any time depending on how the companies are progressing behind the scenes.
While I’m more excited about nearer term potential treatments that are actually in clinical trials I appreciate the admin reporting on all potential treatments when there’s actual news. In addition, not reporting on things like Tiger King and posts totally unrelated to hair loss!
See, MJ’s glass is half full! 😉
This is great news. We all need to try to hang on to what we have a little longer, as it seems there could be a new big three on the market (Follica, Breezula, Samumed) in around 2 years.
no more systemic blockage of DHT and related side effects. a clinical treatment that produces regrowth and creation of new hair follicles better than anything we have now (barring a transplant) and samumed, which im less excited about but at least it would be a new element to throw into the mix.
Multiple office visits…damn.
Hopefully once released, Europe follows soon.
A bit inconvenient flying from Vienna to the US for treatment.
But nevertheless..I am very optimistic that Follica is going to be successful
TissUse & Tsuji Update please
Hagen.
please don’t repeat this, updates don’t fall from the sky. If there are no publications from the companies, there are no updates. It’s not hard to understand. Thank you
Well said Soul!
I am pretty sure that the topical must be different to minoxidil. The majority of people are non-responders. That would be bad for the trial results.
People that assume its just minox do not consider this fact or dont know about it.
It is pretty much confirmed that the topical will be minoxidil. Their treatment is a combination of minox and microneedling so the non-responder rate should be lower than minoxidil alone
I agree that minoxidil is basically confirmed as part of the Follica treatment, I just don’t know if perhaps there is another molecule being used as well. Even if it’s the lithium from their original trials.
And…I highly doubt Follica’s treatment device is simple ” microneedling ” as some posters insinuate. Like they are repackaging Rogaine with a simple device you buy on Amazon. Right, they are in phase III clinicals for that, after many years of perfecting the treatment and you need to go into a Dr.s office to get it. Really??? If someone can show me that this is the case please bring the direct evidence instead of talking out of your, well you know. 😉
Will be interesting to see if it is just minoxidil and a well marketed standardised microneedling system. I am actually doing a one year microneedling experiment to see if I can regrow my hair. I will not be using any topicals or pills.
This is good news. Obviously. But I find it hard to get excited about the possibility of multiple office visits so that we can gain a “statistically significant” result.
I think this is why some of us are more interested in cloning and future treatments. Okay, so we don’t know what (if anything) they will do. Yes, they may take years to arrive. If they ever do.
But there’s nothing wrong with hoping for – and being curious about – a proper solution that will provide noticeable results. That’s why we come to this website. All of us.
I understand that we all have days when we feel frustrated, impatient and hopeless, but let’s be kind to each other.
Nice comment Paul, I hope to be able to share some uplifting news about cloning and next gen treatments going into trials this year.
the question i ask those who follow the blog is: have we ever been with 3/4 companies in phase 3 in the same moment?
You already know the answer my friend. Unfortunately there are those who will find a pile of crap under that pony.
Does anyone know whether or not Follica is publicly traded? Like Histogen, I want to purchase some Follica stocks/shares.
PureTech Health is Follica’s parent company who is public.
If that’s just minoxidil that would suck. So you need to have a doctors visit every week or every month something for the rest of your life? Normal minoxidil is like a daily thing. Or maybe they just have you keep using it at home? Idk…
The doctors visits are likely once every few months or so. The visits going on indefinitely is probably true because the theory is that continuous treatments would lead to continue hair growth and over time a person might be gradually losing hair, however, the idea of doing this the rest of your hair is very unlikely as there will most definitely be superior treatments which come out over the next 10 or so.
What happened to the company in LA with the topical? @FollicleThought
Hi D1 I appreciate your interest in keeping up on that potentially exciting topical. One thing I can say is there won’t be an update about it until there is something posted on the Updates page or an article. I would like to get more info on it just like you, and I continue to try.
@Follicle Thought also what about those WAY like compounds and guiliani?
I will continue to seek info on the WAY compounds and hopefully they give me something to share again.
good stuff @FollicleThought
Will need many more pictures of results before I’m convinced. The photo shown is no better that a good Minoxidil responder. It also shows the crown of the scalp which is where Minoxidil works best. How about the front of the scalp where I am most interested. Even if/when it is approved I will wait for the reviews to come in before I’ll commit.
Where did the idea that Follica’s topical is Minoxidil come from? Have they mentioned it?
From what I understood, Follica’s treatment works by inducing hair follicle neogenesis, which minoxidil cannot do, so they must be using something else?
Yes.
The microneedling induces follicle neogenesis
Sierra, Follica does constantly reference the minoxidil plus microneedling study in their company presentations.
Admin, lets hope it is modified minox.
According to one of your articles, majority are non(weak) responders to minoxidil.
Here comes AB into the picture. Fingers crossed that AB103 hits the market soon.
If not…there will be many people who may get not the results that will be published one day.
But perhaps Follica have addressed this problem and modified minox, therefore the planned pharmacokinetics study.
Is Rivertown therapeutics still starting trials in 2020.
I hope so
Samumed will be out before this.
SM04554 could potentially make a good combination with the Follica treatment regimen.
What do you feel is the most likely best option or options in the next year? Thanks.
dave7, do you mean new treatments? The best overall option in the next year is likely finasteride and minoxidil if you tolerate it well. Of new treatments the best option will be either HairClone or Follica.
hello Admin, hairclone or follica will be the real cure or only best options than finasteryd?
My guess is that HairClone has a chance to be better than finasteride if it works well but Follica in its initial offerings will be not quite as efficient as finasteride.
Also, I have some new content in the works. At least an Update by the end of the weekend.
Follica’s website says ‘Investigational device and *new drug’. And now there is a pharmacokinetic study in phase 3 trials.
Obviously, it’s more than just minoxidil.
I saw the sentence you’re referring to Paul, I’m not sure if it means “investigational new device and (new)drug” or “investigational new device, and drug.”
will it be available on Asia?
I dont have thinning hair. I just have naturally very fine hair and naturally less density around temples(female). What treatment could I do now or in the future to increase hair shaft diameter?
Kind Regards Lily