Lots of New Info on Follica

[resu]

That whole interview sounds like a red herring. Either that or this upcoming treatment is absolutely useless. And where did he mention the hair being unpigmented, I didn't see it.

It was in the BTT, aka the other forum.

 

[Noisette]

Not exactly, Follica use a dermabraison technique (like a CO2 laser) and they inject a product directly after (lithium 8%) in order to create neogenic hairs. For example, you can see the procedure used by a clinician on a male subject with early stage pattern hair loss.





And Here Cotsarelis said "I will check your scalp Hellouser "




source (patent of Follica) : http://www.google.com/patents/US20130204238

[0004]

The wounding of skin by physical means such as microdermabrasion, dermabrasion, and varying degrees of tissue disruption or excision can create a biological milieu of stem cells and inflammatory factors and signaling molecules, the interplay of which can result in neocollagenesis and neofollicles...

[0062]
A particular physiologically active compound or array of two or more compounds may optimally produce a desired end result (for example, follicular neogenesis, reorganizing existing hair structures, dispersing hair-producing components, altering cell-to-cell interactions that are relevant to the growth of hair, or other useful ends) under the dermabrasion model (provided through the disruption of the epidermis and optionally the stratum corneum). For example, it has presently been discovered that the application of a topical formulation of 8% lithium gluconate (such as in the form of Lithioderm®) in a dermabrasion context results in a higher percentage of neogenic hair follicles at a more mature stage of development, increased thickness of hair shafts at the surface of the skin, and in general, a higher number of neogenic hair follicles.

• Method of Treatment of Skin by Disruption and Formation of Void Spaces
• [0174]
  A method according to the present invention for effecting treatment of the skin on a human scalp is performed as follows. A male subject with early stage pattern hair loss is seated in a stationary examination chair. A clinician unseals a kit comprising a handpiece and a set of four containers. A first container comprises 1 mL of a composition comprising lithium gluconate. A second container comprises 5 mL of a composition comprising lithium gluconate. A third container comprises 1 mL of a composition comprising particles of lithium chloride. A fourth container comprises 5 mL of a composition comprising particles of lithium chloride.
• [0175]
  The clinician first links the handpiece to a fractional laser generator, and then powers on the handpiece using a manual control. After a few moments, wireless communication is established between the handpiece and a computer onto which software for controlling the handpiece has previously been loaded.
• [0176]
  The clinician asseses the scalp of the subject, and upon determination that the subject has a relatively minor degree of hair loss, selects the container comprising 1 mL of a composition comprising 8% lithium gluconate and the container comprising 1 mL of a composition comprising particles of lithium chloride. The handpiece includes two chambers for accommodating containers, and the clinician loads a container into each of the two chambers.
• [0177]
  The handpiece is positioned about 5 cm above the surface of an area of the subject's scalp that is selected for treatment because of significantly thinning hair at that location. Using another manual control, the clinician activates a treatment protocol for disruption, formation of void spaces, and application of physiologically active composition to selected the target area. The generator activates a CO[SUB]2 [/SUB]laser on the handpiece, and in accordance with the software protocol, the computer configures the laser so that it applies an ablative fractional pattern at 10,600 nm onto the target area. This pattern is sufficient to remove substantially all of the stratum corneum and epidermis from the portion of the target area onto which the laser is directed. The clinician moves the handpiece over the surface of the skin until an area measuring about 5 cm by 5 cm is treated. At the same time that the laser is being used to remove the stratum corneum and epidermis from the treatment area, the software protocol also directs the computer to configure the laser so that it intermittently forms a fractional ablative pattern that is effective to form void spaces in the dermis tissue at the treatment area. The void spaces are oriented at a substantially perpendicular angle relative to the surface of the skin, and extend to a depth of about 1 mm from the surface of the exposed dermis. Thus, translation of the handpiece over the surface of the skin is effective both to remove the stratum corneum and epidermis and to form void spaces by removal of dermis tissue during such translation.
• [0178]
  The software-directed computer than commands the handpiece to deactivate the laser and a sequence begins for the application of physiologically active composition from the containers onto the injured target area. The clinician positions the handpiece about 5 cm above the surface of the injured skin, and begins translation of the handpiece over the surface of skin as the applicators are activated and begin applying physiologically active composition to the skin by spraying. The physiologically active composition is a mixture of the composition from the first container and the composition from the second container. The handpiece includes a mixing apparatus that combines the contents of the first container with the contents of the second container prior to activation of the applicator. By moving the handpiece over the injured target area, the clinician coats the exposed dermis with the mixed composition until the combined contents of the first and second containers are exhausted. When this occurs, the clinician deactivates the handpiece.
• [0179]
  The clinician then applies a topical anaesthetic spray comprising 10% benzocaine to the injured target area. Next, a wand capable of generating ultrasonic vibration is placed in contact with the injured skin and activated. The clinician performs several passes of the wand over the entire surface of the injured target area in order to encourage penetration of the applied lithium chloride particles into the void spaces.
• [0180]
  The preceding process is optionally performed iteratively with respect to additional target areas. Optionally, each target area is subject to injury by the fractional laser before any target area is contacted with physiologically active composition or subjected to ultrasonic vibration. Thus, the stratum corneum and epidermis may be removed and the void spaces may be formed with respect to all target areas prior to the application of any physiologically active composition or ultrasonic vibration, followed by the application of composition and ultrasonic vibration to all target areas. After ultrasonic vibration, the clinician may apply additional topical anaesthetic, antimicrobial compositions, bandaging, or any combination thereof, which marks the end of the treatment session for the subject.

 

[Dales]

But that also might depend on the size/depth of the wound.

I already asked this, but didn't get any answer.

How come nobody tried dermabrasion while so many people experimented with dermarolling ?

By looking at Follica patents it seems clear that they are doing some sort of dermabrasion.

Abrading the top layer of the skin and puncturing the skin are two completely different wounding methods so why is everybody talking about dermarolling and not dermabrasion ???

 

[Noisette]

because dermabrasion must be controlled by a clinician (as you have to use a CO2 laser etc...). Perhaps, a microdermabrasion would make a difference, more than a dermarolling. And you need to test it with lithium 8%

 

[Kirby]

I don't know if you have read this document. On it, you can see few things: (page 106)
http://puretechhealth.com/images/investors/Puretech_Pi_e-Prospectus_Final_T08_CNB-v2.pdf

Mice again.

 

[Pray The Bald Away]

And Here Cotsarelis said "I will check your scalp Hellouser "

LOL

 

[Pavi]

So what's the bottom line fellas? Is this a "hey this will come out in 2-3 years" or 5+

 

[Pray The Bald Away]

because dermabrasion must be controlled by a clinician (as you have to use a CO2 laser etc...). Perhaps, a microdermabrasion would make a difference, more than a dermarolling. And you need to test it with lithium 8%

Lithium 8% already failed. It said so in the forst press release.

- - - Updated - - -

First*

- - - Updated - - -

And Noisette, does this mean the procedure is only for people with very early hair loss? What constitutes early hair loss? NW2-3-4?

 

[Noisette]

Mice again.

Not only on Mice Both, Mice and Humans. They have completed 3 clinical studies
and Olle said “all of which confirm that we can consistently create new hair follicles in mice and in humans. As far as I know, no other approach has been able to achieve that.”

And " Based on previous experiments, Follica believes that it has several potential drug candidates to add to TCP to enrich for terminal hair. Follica’s hypothesis was further strengthened when a third party academic group, working independently of Follica, published positive results using a form of TCP and one drug Follica plans on adding to TCP in the future. The company believes that the work that was done by the third party group was covered under its filed intellectual property (please see below table and discussion of intellectual property).

Lithium 8% already failed. It said so in the forst press release.

- - - Updated - -
And Noisette, does this mean the procedure is only for people with very early hair loss? What constitutes early hair loss? NW2-3-4?

I think that is also for high norwood like 5. Because on an old patent (clinal trial phase IIa) they said they have test it on Norwood 3, 4 and 5
So their protocol would be enhanced since this clinical study
"
8.1 STUDY PROTOCOL
[00637] The following protocol describes a Phase Ila clinical study that evaluated the effect of dermabrasion and post-perturbation treatment with a hydrogel (comprising Carbomer (Carbopol 980), glycerol, sodium hydroxide, methylparaben, propylparaben, and purified water) on (i) the formation of neogenic-like or activated or stimulated hair follicle structures (e.g., NL, PEL and PELA as described in Section 5.8.4.1 supra) and (ii) hair growth.

[00638] Diagnosis and main criteria for inclusion are Caucasian males 20-65 years of age, providing written informed consent, who have androgenetic alopecia with the presence of a vertex transition zone defined as an area possessing both terminal and miniaturized hairs, Hamilton-Norwood type 3V, 4, 5, 5A, or 5V, with a vertex area large enough to accommodate both treatment sites, and Fitzpatrick skin type 1-4. "

"[00658] In dermabraded areas of skin, induction of neogenic-like hair follicles and activated, stimulated, or reorganized pre-existing (including vellus-sized) follicles was measured as detected and analyzed by skin biopsy analysis at Day 14. In contrast to what is generally found in unwounded scalp skin,the controlled perturbation in this study 1) induced neogenic-like follicles and 2) placed preexisting follicles into a reorganized and activated state. The structures of interest detected and counted in the Day 14 biopsies are observed only rarely in unwounded skin. Therefore, they are comprised of neogenic-like and activated, stimulated, or reorganized structures "

[00656] It was found that, for subjects treated with dermabrasion plus hydrogel:
• From baseline to Day 84 (3 months), target area hair counts (also referred to as "TAHC") of all hair show substantial increases that are statistically significant (see Table 9). This change in counts of all hair from baseline is maintained through the last day of measurement, Day 168 (6 months; See Table 10) and the change is statistically significant on Day 168.



source: https://www.google.com/patents/WO20...ved=0ahUKEwiQuLjq3-DMAhWThRoKHabpA4cQ6AEIMzAD

 

[Pray The Bald Away]

Diagnosis and main criteria for inclusion are Caucasian males 20-65 years of age, providing written informed consent, who have androgenetic alopecia with the presence of a vertex transition zone defined as an area possessing both terminal and miniaturized hairs,

Would it still work on slick bald temples? It kind of sounds like it only works on areas that are undergoing the thinning and miniaturizing process.

 

[hellouser]

Would it still work on slick bald temples? It kind of sounds like it only works on areas that are undergoing the thinning and miniaturizing process.

Neogenisis should work on any scalp.

- - - Updated - - -

And Here Cotsarelis said "I will check your scalp Hellouser "

LOL!

 

[KG21]

If this works as well as we are being led to believe, is this a relatively functional cure? What about non-miniaturizing hairs? Is finasteride still the best option for maintaining?

 

[Mach]

Some studies are comparing lithium gluconate to ketoconazole 2%. This has been addressed before but not with a dermabrasion.

 

[Pray The Bald Away]

I read through the study and it seems that they are only treating areas that have a mixture of terminal hairs and currently miniaturizing hairs. This means they probably wont treat any slick bald areas. That's pretty disappointing...

 

[Baldybald1]

What are you talking about man

 

[Kirby]

This is probably Cots trolling again. Besides, I've noticed this hasn't appeared on the radars of the other hair loss forums.

 

[Baldybald1]

:\

 

[NewUser]

Noisette's post at no. 107 explains a lot about the technique

 

[Swoop]

i think Follica will probably try to improve on that efficacy and using their own formula with multiple drugs. From news item linked to by Xaser:

That will take a long long time though right. Introducing new compounds that are not approved yet, require vigorous testing just as any other drug. Takes many years. On the short term it seems clear that they are opting for 501K approval for their device (same as LLLT for instance).

 

[NewUser]

It simply says in Noisette's post at 107 they are using existing drugs as well as new chemical entities to affect new follicle growth or neogenesis. I think that is good news no matter which Norwood number we are. Follica has 32 patents and applications. That's more patents than any other hair r&d company but still no revenue stream. I think investors must now be screaming for a product and dividends. And it does appear they are aiming to produce a new treatment or procedure within two years.

Sounds like following treatment by a trained clinician, there will be a Smart phone app for at-home use of a digital TCP device and already approved drugs. This is near term according to page 105 of the report.

And then in Section 7.1 paragraph 2 it does mention developing newer drugs over the longer term for use with the TCP device. Wow, what if they ever decide to try it with a JAK-inhibiitor, like Christiano's yet-to-be-developed topical which, as she says, will have a short time to failure or success meaning they will know soon enough if topical Tofacitinib works in cases of androgenic alopecia. Could well be the end for pattern baldness. But Follica's TCP device will be at the base of what appears will be a continuously improving procedure beginning with TCP and hair growth chemicals applied to scalp as part of a regimen or some such. Sounds to me the beginning of the end for baldness. This in concert with announcements even if sporadic from other companies is very good news i think.