Follica Pivotal Trail Is Now Recruiting

SamFT

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On the one hand, frustrating personally that it took so long but on the other hand, it's great its finally happening.

by 2019 end: Samumed, Follica, Breezula all in phase 3 trials? after years, suddenly things are happening all at once!
Samumed and
So are they going to finish this until 2020 and maybe start phase 3? As far as I remember they could maybe repair FUE/FUT scars, would be great though...what happened to Noisette?
No. This is considered a Phase lll “ A pivotal trial is a clinical trial or study intended to provide evidence for a drug marketing approval, e.g. by the United States Food and Drug Administration. Phase III trials are assumed to be pivotal so the phrase is often used for the rare pivotal phase II trials.”
 

That Guy

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Get ready for all kinds of "reeeeeee"-ing from the asshurt autists of the forums.
 

Xaser94

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Always glad to see Follica progress :). Not tryna derail the good news, but is there anything that actually states that this is for the pivotal trial, and not just an optimization study?
 

JimmyB

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I have a feeling Follica has done additional research that makes them confident this will get to market. The fact that they have a site and app in works and have basically started marketing it (based on what I read from some dermatologists a couple months ago) reinforces that. Things can always go wrong tho.

They've also consistently stated that the treatment can create new follicles - maybe their short trial is based less on regrowth and more on looking for evidence that new follicles are developing.
 

JimmyB

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Always glad to see Follica progress :). Not tryna derail the good news, but is there anything that actually states that this is for the pivotal trial, and not just an optimization study?

The recruitment flyer is definitely from the optimization study or something else, as it was posted in February. Looks like this is hairlosscure posting BS again.
 

HairlossCurse

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If it is testing for follicle neogenesis (new follicles) then theoretically 12 weeks would be enough. I doubt 12 weeks is enough to prove hair growth though but who knows.
 

Xaser94

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The recruitment flyer is definitely from the optimization study or something else, as it was posted in February. Looks like this is hairlosscure posting BS again.

Yeah I can't see Puretech not mentioning phase 3 pivotal trials have started in their last document they released this month (or last month was it?). This seems more like their optimization study, which is fine, because at least we know the optimization trials seem to be fairly short. If it started in February, they must be finishing up by June if it's 12 weeks. Maybe the latest by end of summer if they only started a few months after February to account for recruitment time.
 

MeDK

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Yeah I can't see Puretech not mentioning phase 3 pivotal trials have started in their last document they released this month (or last month was it?). This seems more like their optimization study, which is fine, because at least we know the optimization trials seem to be fairly short. If it started in February, they must be finishing up by June if it's 12 weeks. Maybe the latest by end of summer if they only started a few months after February to account for recruitment time.

According to their own website where they are in the development phases, they're done with phase II and ready for phase III / Pivotal

Homepage on the top is the pipeline
 

MeDK

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Found something in the Follica patent description WO2012078649A1

A part of their claim. Which also explains why the phase III is so short, they claim there is some short of result at 3 months.

4. A method for treating baldness in a human subject, wherein the method comprises:
a) integumental perturbation of an area of the bald scalp of the human subject;
b) administering a hair growth promoting agent, wherein, at 3 months after the integumental perturbation, the area of the scalp of the subject has at least 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or at least 100% more vellus hair compared to immediately before the integumental perturbation.

Here is how the procedure is

0065] In certain aspects, the invention provides a method for inducing hair growth on the scalp of a male or female subject with androgenetic alopecia, wherein the method comprises:

(i) Dermabrasion (estimated depth 100 - 150 microns) at Day 0;

(ii) Commencing at Day 0, topical administration of hydrogel for about 1 1 days;

(iii) Immediately following step (ii), topical administration of minoxidil 2-5% solution and/or minoxidil 2-5% gel and/or minoxidil 2-5% foam for at least 3 months, or in another embodiment, at least 6 months.

(iv) In certain specific embodiments, the dermabrasion tip described in Section 5.1 infra is used in step (i)

(v) In certain specific embodiments, the subject receives an additional treatment with topically administered 0.005% or 0.01% or 0.1% latanoprost.

(vi) In certain specific embodiments, the subject receives an additional treatment with topically administered 0.01% or 0.03% bimatoprost.

(vii) In certain specific embodiments, the subject receives a treatment with topically administered 0.005% or 0.01 % or 0.1 % latanoprost after step(ii) instead of minoxidil, (vi) In certain specific embodiments, the subject receives a treatment with topically administered 0.01% or 0.03% bimatoprost after step(ii) instead of minoxidil. [0066] In certain aspects, the invention provides a treatment regimen that starts minoxidil as soon as re-epithelialization is complete. In one embodiment, re-epithelialization is complete between 11 days and 14 days after post integumental perturbation.
 

SamFT

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So this will be the last trial for Follica?

I always heard phase III trials were the longest though.
Yes it should be. Phase lll are usually the longest when it goes to systemic drugs especially. And because there are hundreds if not thousands of people in trials. I know follica is taking a different more efficient path because of the way their treatment works. Unfortunately they seem to be taking their sweet *** time with it though.
 

tomJ

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Anyone know when the trial actually will end? You figure at least another 6 months after the trial ends before they even offer any more info.
 

MeDK

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Anyone know when the trial actually will end? You figure at least another 6 months after the trial ends before they even offer any more info.

we know the study will be 12 weeks or months. How long it take to treat the data and so on we can't really say.

And if the data is good enough, then there is the FDA approval and so on.

According to FDA, it can take 1 - 4 years to complete a phase III

After completion of Phase III then FDA needs to review it, which takes 6 - 10 months.

So if its best case scenario, then it could be out in 18 months after the start of the Phase III
Worst case 58 months or almost 5 years
 
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HowardWulkan

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So, are they still pushing the new hair follicle creation angle? I remember that's what made me excited about it initially but it seems like if it's just a fancy needling kit it wouldnt make new follicles since there no literature suggesting needling does that?
 

noveau22

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we know the study will be 12 weeks or months. How long it take to treat the data and so on we can't really say.

And if the data is good enough, then there is the FDA approval and so on.

According to FDA, it can take 1 - 4 years to complete a phase III

After completion of Phase III then FDA needs to review it, which takes 6 - 10 months.

So if its best case scenario, then it could be out in 18 months after the start of the Phase III
Worst case 58 months or almost 5 years

damnn....so much for hope. thank you for estimating all the times for us though.
 

Trouse

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Four years for a clinical trial for a cosmetic treatment is soul crushing. Just let me sign a goddamn waiver and I’ll take the chances.

Another hype train derailed before it even leaves the station.
 
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