Follica Microneedling Protocol Patent Disclosed

benjt2

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Since @Xander94 opened his Follica dermabrasion device patent thread, I did some digging into other patents by Follica. And, guess what: Another one has been filed: Methods for promoting hair growth. It is much more recent than the one found by Xander and it is about microneedling. Thus, as this looks much more like "the real deal", I decided to dedicate a separate thread for it.

I actually read the whole patent. Here is the short version of Follica's preferred protocol (they have different protocol versions):
  • The primary target is to produce 1600 thin needle wounds per cm² every two weeks (their preferred parameter configuration is: using a 12 needle head (2 rows with 6 needles) with a width of 0.9 cm at a movement speed of 2 cm per second and an osicllation speed of 120 Hz)
  • Needling device: electric dermaneedling device. They specifically state that dermarollers and dermabrasion devices are less effective. About dermarollers they write that tearing and cut-like wounds are ineffective for neogenesis and that one has to aim for real, "pointy" needle wounds without any tearing or cutting.
  • Needle target depth: 0.8 mm. For long hair, this can be increased to 1.0 mm, but definitely not more than that. The wound should extend 0.8 mm into the skin but not deeper, 1.0 mm is only to compensate for longer hair.
  • Needling frequency: Once every two weeks produces the best results, followed by once a week, followed by once every 4 weeks
  • Needling head: 12 needles in an array of 2 x 6 at a width of 0.9 cm for the needle rows. Their specific design is described in Figure 105 of this patent of theirs
  • Topical, 1st version: minoxidil 5% is the likely first version of the topical (maybe also finasteride or saw palmetto included, but about this I'm not sure)
  • Topical, 2nd version: The second version of the topical is minoxidil plus one or a combination of the following three: finasteride, valproic acid, latanoprost
  • Topical application frequency: Twice daily, preferrably once every 12 hours
  • Areas to needle: Not only affected areas should be needled, but also at least 2 cm into non-bald/non-balding areas. Reason for that is probably quorum sensing.
  • Needling device movement over the scalp: Each area should be covered at least once and at most twice, depending on the protocol variant. Depends on frequency and a few other things - won't go into detail here now, the details can be found in the patent. Short version: In the preferred protocol, each treatment area is covered once in horizontal and once in vertical movement direction over the scalp, making for a total of exactly two passes. Passes should be performed without any overlaps and without any gaps. They use the term "like a lawn mower" several times to describe how the scalp should be covered.
  • Needling movement speed: 2 cm per second. They state that the translational movement speed is important to achieve the target needle hole density of 1600 per cm².
  • Needling head oscillation frequency: 120 Hz
  • Needling pressure: Only slight pressure such that the needles go all the way (0.8 mm) in, but not more. "Gliding" should be achieved.
Now the thing is that the needle heads for the dermapen devices we have are not arranged in 2 rows of 6 needles each. I'm also not sure of the oscillation frequency of the pens we have. We should do some calculations how we can best get to the primary target of 1600 wounds per cm² once every two weeks.

For those who want to read the patent, a hint on how to read patents: "In one embodiment" refers to specific and most effective product designs they plan on releasing, "in some embodiments" refers to other, less effective versions which they want to protect as well but do not necessarily plan on implementing.

As you can see, the protocol is not trivial to replicate (because of parameters, needle heads, but also for covering each area only twice without any gaps or overlaps, especially areas we can't see like the vertex), but this seems what they aim for. Let's see if we can somehow achieve the same.
 
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Tom4362

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Since @Xander94 opened his Follica dermabrasion device patent thread, I did some digging into other patents by Follica. And, guess what: Another one has been filed: Methods for promoting hair growth. It is much more recent than the one found by Xander and it is about microneedling. Thus, as this looks much more like "the real deal", I decided to dedicate a separate thread for it.

I actually read the whole patent. Here is the short version of Follica's preferred protocol (they have different protocol versions):
  • The primary target is to produce 1600 thin needle wounds per cm² every two weeks (their preferred parameter configuration is: using a 12 needle head (2 rows with 6 needles) with a width of 0.9 cm at a movement speed of 2 cm per second and an osicllation speed of 120 Hz)
  • Needling device: electric dermaneedling device. They specifically state that dermarollers and dermabrasion devices are less effective. About dermarollers they write that tearing and cut-like wounds are ineffective for neogenesis and that one has to aim for real, "pointy" needle wounds without any tearing or cutting.
  • Needle target depth: 0.8 mm. For long hair, this can be increased to 1.0 mm, but definitely not more than that. The wound should extend 0.8 mm into the skin but not deeper, 1.0 mm is only to compensate for longer hair.
  • Needling frequency: Once every two weeks produces the best results, followed by once a week, followed by once every 4 weeks
  • Needling head: 12 needles in an array of 2 x 6 at a width of 0.9 cm for the needle rows. Their specific design is described in Figure 105 of this patent of theirs
  • Topical, 1st version: minoxidil 5% is the likely first version of the topical (maybe also finasteride or saw palmetto included, but about this I'm not sure)
  • Topical, 2nd version: The second version of the topical is minoxidil plus one or a combination of the following three: finasteride, valproic acid, latanoprost
  • Topical application frequency: Twice daily, preferrably once every 12 hours
  • Areas to needle: Not only affected areas should be needled, but also at least 2 cm into non-bald/non-balding areas. Reason for that is probably quorum sensing.
  • Needling device movement over the scalp: Each area should be covered at least once and at most twice, depending on the protocol variant. Depends on frequency and a few other things - won't go into detail here now, the details can be found in the patent. Short version: In the preferred protocol, each treatment area is covered once in horizontal and once in vertical movement direction over the scalp, making for a total of exactly two passes. Passes should be performed without any overlaps and without any gaps. They use the term "like a lawn mower" several times to describe how the scalp should be covered.
  • Needling movement speed: 2 cm per second. They state that the translational movement speed is important to achieve the target needle hole density of 1600 per cm².
  • Needling head oscillation frequency: 120 Hz
  • Needling pressure: Only slight pressure such that the needles go all the way (0.8 mm) in, but not more. "Gliding" should be achieved.
Now the thing is that the needle heads for the dermapen devices we have are not arranged in 2 rows of 6 needles each. I'm also not sure of the oscillation frequency of the pens we have. We should do some calculations how we can best get to the primary target of 1600 wounds per cm² once every two weeks.

For those who want to read the patent, a hint on how to read patents: "In one embodiment" refers to specific and most effective product designs they plan on releasing, "in some embodiments" refers to other, less effective versions which they want to protect as well but do not necessarily plan on implementing.

As you can see, the protocol is not trivial to replicate (because of parameters, needle heads, but also for covering each area only twice without any gaps or overlaps, especially areas we can't see like the vertex), but this seems what they aim for. Let's see if we can somehow achieve the same.
Ok so its about official that they will not be doing daily needling?
 

otann

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Thank you for the summary, @benjt2.
... their preferred parameter configuration is: using a 12 needle head (2 rows with 6 needles) with a width of 0.9 cm at a movement speed of 2 cm per second and an osicllation speed of 120 Hz) ...

For reference, the needles of the 12-count cartridge sold for use with the Derminator 2 are organized in a ~0.5-cm diameter circle, and more importantly, the console's "fast" needling frequency is a relatively paltry 25 Hz. Thus, even if one were to use the 12-needle cartridge and attempt to replicate the described needling pattern, speed, and depth (0.75 or 1.00 mm) to the best of their ability, wounding density would be significantly lower than ideal.

One pass over a 1-cm² section of scalp at a constant rate of 2 cm/s with 12 needles oscillating at 120 Hz should yield a density of 720 wounds/cm². They prefer two passes (one horizontal and one vertical), bringing density up to 1440 wounds/cm², which is a bit short of their proposed ideal of 1600 wounds/cm². I haven't read the details yet, so I'm sure that this disparity is the result of factors that I haven't accounted for.

Since the Derminator 2 has a maximum needling frequency of 25 Hz, you'd have to complete ~10 passes at a rate of 2 cm/s to achieve the same density.

 
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coolio

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So, to summarize. . .


- Low depth, 0.8mm to 1.0mm.

- 1600 holes per sq/cm in total (per session). That's a pretty monstrous amount of holes in a small area. The needles must be very small diameter or your skin will be one big mess by the time the density is achieved.

- Holes go straight in & out. Damage from rolling methods is not helpful.

- Needling once every two weeks is the most effective spacing.

- the area of needling must extend 2 cms beyond the area where new hair is wanted.

- minoxidil still appears to be the primary drug.
 

Derelict

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To be honest im a bit disappointed in follica if it's still minoxidil, i was hoping for a new topical along with the needling. I wonder if this same approach to needling would have positive effects if you are on oral minoxidil.
 

benjt2

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Ok so its about official that they will not be doing daily needling?
Yes. Once a week, once every two weeks, or once every 4 weeks.

Do they apply minoxidil on needling day?
No they don't, but this might be due to safety concerns and not because of effectiveness. They mention safety and minoxidil concentrations a couple of times in the patent. In fact, one version of their protocol says that on the first two days after needling, 2% minoxidil should be used instead of 5%.

- 1600 holes per sq/cm in total (per session). That's a pretty monstrous amount of holes in a small area. The needles must be very small diameter or your skin will be one big mess by the time the density is achieved.
Seems to be the case, yes. The patent mentions a couple of times the process of "re-epithelialization", which is the reconstruction of the whole epidermis if I understood correctly. This would obviously require significant punch hole density. See the following part of their patent:
Protocol patent said:
In one embodiment, integumental perturbation comprises disrupting the skin of the subject (for example, resulting in the induction of re-epithelialization of the skin of the subject). In some embodiments, a certain area of the epithelium is partially or wholly disrupted. In some embodiments, a certain area of both the epithelium and stratum corneum are partially or wholly disrupted. For a discussion of skin disruption and re-epithelialization, including methods for disrupting skin and inducing and detecting re-epithelialization, see PCT Publication Nos. W02008/042216, WO 2006/105109, WO2012078649, the contents of each of which are incorporated herein by reference in their entireties.


more importantly, the console's "fast" needling frequency is a relatively paltry 25 Hz.
The TBPHP pen goes much faster. Slowest setting is 8,000 oscillations per minute, which translates to 133 Hz. Pretty close.

One pass over a 1-cm² section of scalp at a constant rate of 2 cm/s with 12 needles oscillating at 120 Hz should yield a density of 720 wounds/cm². They prefer two passes (one horizontal and one vertical), bringing density up to 1440 wounds/cm², which is a bit short of their proposed ideal of 1600 wounds/cm². I haven't read the details yet, so I'm sure that this disparity is the result of factors that I haven't accounted for.
They specify in the patent that a range between 1400 and 1800 wounds per cm² is ok, with 1600 being optimal. If we remember their leaked trial slides, towards the end they say that there is a lower bound and upper bound for neogenesis; guess they found the range to be 1400 to 1800. 1600 is right in the middle.

What bothers me a bit is the question of depth. In their most recent patent on needling protocol, they state the following:
Needling protocol patent said:
[...]the target depth is 0.8 mm or 800 µm.

However, the needling device patent which they refer to states the following:
Needling device patent said:
In one aspect, a needling device or needling adaptor described herein is suitable for disrupting skin to a penetration depth of between 30 μm to 200 μm (e.g., to a maximum depth of 30, 40, 50, 60, 70, 80, 85, 90, 95, 100, 105, 110, 120, 130, 140, 150, 160, 170, 180, 190 or 200 μm), and preferably to approximately 100-150 μm. In one aspect, a needling device or needling adaptor described herein is suitable for disrupting skin to a depth of 100 μm. In one aspect, a needling device or needling adaptor described herein is suitable for disrupting skin to a depth of 150 μm.

This is confusing. In their device patent - which is older - they prefer 0.15 mm, now in their more recent patent they state they prefer 0.8 mm. Don't know which one is right or why they contradict each other.


By the way, I calculated their needle spacing to be between 0.14 and 0.16 mm apart in the same array line, and 0.2 to 0.22 mm apart diagonally across the two array lines (which are shifted a bit). If we imagine the two lines being dragged across the scalp horizontally and vertically and that all needles are placed equidistant from one another, this leads to a maximum distance between "hole lines" of 0.07 mm. No hole will be further away from another hole than 0.07 mm.
 
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coolio

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I wouldn't be surprised if they stopped at 1600 just because their hole-making process was hitting diminishing returns.

When the hole density gets high enough then eventually you will struggle to make any more holes. The needles will be landing in previously-made holes more often than on smooth skin.
 

benjt2

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I wouldn't be surprised if they stopped at 1600 just because their hole-making process was hitting diminishing returns.

When the hole density gets high enough then eventually you will struggle to make any more holes. The needles will be landing in previously-made holes more often than on smooth skin.
This seems to be their intention.
I'll quote from the patent:
Protocol patent said:
Given a frequency of needle array reciprocation (e.g., 120 Hz), this creates the desired density of needle strikes with each strike slightly overlapping the prior.


To prevent any dragging or tearing, their device's needles seem to be able to retract fully out of the skin, no matter how deep they go in. I'm not sure the TBPHP pen can do that at bigger depths, though maybe at 0.8 mm it might be possible.

Anyway, I will try to replicate their protocol as closely as I can. Probably it won't work, but at least I can give it a try.
 

inmyhead

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1600 wounds per cm2? This looks impossible using derminator unless you keep it on one sport for a long time, but it woundn't be same effect..
 

hairloss_user

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Might have missed it, but if I get this right:

Needle once every 2 weeks for a while (how long?), then do it once every month?

What about daily needling? Do you still need to do that? At what depth if so?
 

hairloss_user

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I've been needling for over a year. First I did 1,5 mm every week for like 3-4 months, then every 2 weeks for another 3-4 months, then once every 3 weeks until now. All of my old progress pics are on my old phone that broke down, but I am sure I've maintained, possibly some slight thinning in the crown, but I'm not sure if it's because I changed the frequency or something. Either way, needling makes my hair feel alive if that makes sense. It doesn't lay flat and lifeless like it used to, so it's doing something good. Recently I've added daily needling at 0,5 mm too.

I am going to continue, but I am still interested in changing to Follica's way. Maybe add that valproic acid and latanoprost, but how do you even get those ??
 
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HairOnFire

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  • The primary target is to produce 1600 thin needle wounds per cm² every two weeks (their preferred parameter configuration is: using a 12 needle head (2 rows with 6 needles) with a width of 0.9 cm at a movement speed of 2 cm per second and an osicllation speed of 120 Hz)
.

Over the long haul, that's a lot of trips to the clinic.

Thanks for the comprehensive review of the patent.
 

pegasus2

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1600/cm² is probably more than anyone has done. I doubt that any of the Chinese pens actually operate at close to the rated specs, so if you're using those it's going to be hard to target within a specific range of 1400-1800/cm². The needles on the Derminator 2 needles are the finest at 34.5 gauge. The closest is the A7 at 34 gauge. I recommend sticking with one of those two. With the Derminator you will just have to move it slower, 2 passes at .75cm per second, to get the right density. It's not going to be easy to move that slow, and it's going to take more than 15 minutes to complete both passes if you're balding in a NW7 pattern.

This is a 100hz pen vs the 25hz Derminator 2:
img06.jpg

I still believe that the best method may be dense/deep wounding every 2 weeks in conjunction with light .25mm wounding every day or two for increased absorption of topicals and release of growth factors.

Everyone please keep in mind that they have run trials since submitting these patents. Latanaprost can be bought under the brand name Xalatan for eyelash growth, but it's very expensive to buy enough to cover your entire scalp. It's basically the same thing as bimatoprost which is cheaper, but also very expensive.
 
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ZP31

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So follica spent a few years to decide which marketing approach would be best, using already existing and inadequate treatment options, combining them into a “patent”.

- Micro-needling, a pathetic temporary self harm approach that does absolutely nothing and there are papers suggesting it does harm long term
- latanoprost, an even more pathetic eyelash treatment that is said to do more harm than good and does nothing to halt Androgenetic Alopecia or regrow hair
- minoxidil, a treatment that destroys your face and buys you a few half dead strands of hair
- topical finasteride, the big meme that wouldn’t even live long enough to be exploited by transplant clinics because IT IS THAT STUPID
- valproic acid, kill me

Wait it isn’t over yet. Let’s do a Reddit survey, find which microneedling approach seems to be best and just do that.

There goes your 2020-2030 super anticipated hair loss cure.


I’m back with a vengeance.

I agree with everything except the point about topical finasteride. Although not as effective as the oral version, I would make the argument that it can be useful and certainly better than nothing.
 

newdutuser10

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I too am going to just do dermarolling with a roller on alternate days for absorption for the next 4 months and then try the Follica way. This way I'll be able to figure out on my own which one works better for me.


I'm going for absorption like Somebodyalex and then I'll go for twice a week needling.
 

pegasus2

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If your device has more than 12 needles per .9cm, just adjust the speed to achieve a density of 1600/cm². It's perfectly fine.

"First, the number of (1) needle strikes per second can be calculated by multiplying: (1A) number of needles per needle array by (1B) the number of array oscillations per second.

Second, the treatment area covered per second can be calculated by multiplying (2A) width of treatment (e.g., measured as the width of the needle array) by (2B) device translation speed. Overall, (1) the number of needle strikes, divided by (2) treatment area, multiplied by (3) the number of overlapping passes, results in the needle strike density. Several

permutations of these treatment parameters exist in which equivalent treatment density is achieved."

Also of note with this treatment protocol
"79% of subjects showed an increase in non-vellus target area hair count of more than prior large minoxidil studies described in Olsen 2002 and Olsen 2007. In these earlier minoxidil- only studies, both 5% MTS 5% and 5% minoxidil foam achieved an average of 12% increase above baseline"
 
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HairOnFire

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The primary target is to produce 1600 thin needle wounds per cm² every two weeks
I only skimmed a small portion of the patent, but the term they actually use is "needle strikes" per sq/cm. 1600 strikes may or may not mean 1600 distinct wounds. In order to get 1600 needle strikes in the target area using 12 needles, you'd need about 133 strikes with that pen. I doubt there is 1:1 correlation between a strike and a distinct wound column, as surely the strikes in the second vertical pass are going to overlap to some degree with the first set of horizontal strikes.
 
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