Follica Pivotal Trail Is Now Recruiting

[SamFT]

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

Yes he is correct. Most phase lll take 1-4 years because they are systemic drugs that might be the first generation in its class. Follica is using compounds already understood. Including their microneedling. There are exceptions to phase lll just like their is for other trials. (Example: SETI was already understood to be safe for allergies so they started a Phase ll right away). It’s a small time frame. If this pivotal is actually 12 weeks and not the optimization study yes we could definitely see this next year.
FDA reviewing can take up to 6-12 months because they review all the data that is submitted. Do you really think it will take 12 months to analyze phase lll data from participants that might only be in the few hundreds compared to other phase lll trials that have THOUSANDS of participants and trials lasting up to 4 years?
Everyone needs to relax it will not take that long if everything is going the way we think it is.

 

[SamFT]

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?

Yes there is. They stated already that just the follica Treatment (No drugs) caused new hair growth.

 

[BalderBaldyBald]

Yes there is. They stated already that just the follica Treatment (No drugs) caused new hair growth.

Yeah, 2 terminals and 20 vellus

Hooray for No Drugs

 

[hrplz]

Yes he is correct. Most phase lll take 1-4 years because they are systemic drugs that might be the first generation in its class. Follica is using compounds already understood. Including their microneedling. There are exceptions to phase lll just like their is for other trials. (Example: SETI was already understood to be safe for allergies so they started a Phase ll right away). It’s a small time frame. If this pivotal is actually 12 weeks and not the optimization study yes we could definitely see this next year.
FDA reviewing can take up to 6-12 months because they review all the data that is submitted. Do you really think it will take 12 months to analyze phase lll data from participants that might only be in the few hundreds compared to other phase lll trials that have THOUSANDS of participants and trials lasting up to 4 years?
Everyone needs to relax it will not take that long if everything is going the way we think it is.

I believe at one point it was mentioned that Follica plans to go the 510(k) route, which is 90 days, for this initial effort. Not sure if that's still the case.

510(k)
https://www.fda.gov/medicaldevices/...ovalsandclearances/510kclearances/default.htm

 

[MeDK]

I believe at one point it was mentioned that Follica plans to go the 510(k) route, which is 90 days, for this initial effort. Not sure if that's still the case.

510(k)
https://www.fda.gov/medicaldevices/...ovalsandclearances/510kclearances/default.htm

Couldn't that be for the actual device? Since they're developing a device.

But they also do clinical trails for what ever compounds used with their device. So might be two different approvals they needs from FDA.

I don't know really.

 

[hrplz]

Couldn't that be for the actual device? Since they're developing a device.

But they also do clinical trails for what ever compounds used with their device. So might be two different approvals they needs from FDA.

I don't know really.

Yeah, I'm not certain either. In this first go-round, they're using approved drugs. Not sure if combining approved drugs - or combining approved drugs and a device - requires a separate review.

 

[Jakejr]

I wouldn’t get my hopes up.
We can all do microneedling at home now.
We have all the topicals they have & more. We know microneedling induced growth factors in scalp. Most people rub minoxidil(topicals) on top of scalp. Now we are going deeper. Probably a good idea. The follicle bulb is deeper. But without addressing the DHT binding internally, I wouldn’t get too excited.
I have Duasteride & Sarms S4 topicals & in conjunction with microneedling, supplements pantogar & lactoferrin starting to see healthy hair growth.
People keep talking about DHT. After all my supplements,and I work in even more, my facial hair is still strong. Some hairs on back & chest not so much. My point is the male body is producing so much DHT; if this isn’t addressed, & there are good options we are just whistling in the wind.

 

[MeDK]

I wouldn’t get my hopes up.
We can all do microneedling at home now.
We have all the topicals they have & more. We know microneedling induced growth factors in scalp. Most people rub minoxidil(topicals) on top of scalp. Now we are going deeper. Probably a good idea. The follicle bulb is deeper. But without addressing the DHT binding internally, I wouldn’t get too excited.
I have Duasteride & Sarms S4 topicals & in conjunction with microneedling, supplements pantogar & lactoferrin starting to see healthy hair growth.
People keep talking about DHT. After all my supplements,and I work in even more, my facial hair is still strong. Some hairs on back & chest not so much. My point is the male body is producing so much DHT; if this isn’t addressed, & there are good options we are just whistling in the wind.

We can do a lot at home, but are we doing it right?

People adds loads of stuff and things more is better. Some studies shows, if you use to much of one ingredient it have the opposite effect. And we don't even know what happens if we adds all of it into one big treatment. So maybe what people are doing at home is not doing it right, and might just add more damage than good.

And follica have a different approach to micro needling. Can't remember if they also do it with a 45 degree angle instead of a 90 degree angle. Also they have realized that human skin isn't like the skin on mice, and therefore needs a compound to active that regeneration in human skin or else we could just add more scar tissue and do nothing good with micro needling.

There are many "maybe" "if" "can" "possible" and so on in the equation still, but at least it seems like they're getting better at removing the uncertainties in the equation and move closer to a treatment that works well for the majority of the balding community.

 

[benjt2]

Did anybody notice yet that Phase 2b and 3 are sometimes both called pivotal?

Are we sure this is Phase 3 and not Phase 2b?

 

[MeDK]

Did anybody notice yet that Phase 2b and 3 are sometimes both called pivotal?

Are we sure this is Phase 3 and not Phase 2b?

Puretech health pipeline

If you look at their pipeline, Immune System, Follica, then you can see at Trail Phase, Phase 3/ Pivotal

Next time, try and look at the respective different webpages before asking, their website have been referred to more than once really.

 

[dermrafok]

Did anybody notice yet that Phase 2b and 3 are sometimes both called pivotal?

Are we sure this is Phase 3 and not Phase 2b?

Phase 2b is completed.

Samumed is in Phase 3 too:
A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

https://clinicaltrials.gov/ct2/show/NCT03742518?term=samumed

 

[itsjustsimon]

Did anybody notice yet that Phase 2b and 3 are sometimes both called pivotal?

Are we sure this is Phase 3 and not Phase 2b?

I would say that if they call it PIVOTAL it probably means they are phase 3.

 

[MeDK]

Phase 2b is completed.

Samumed is in Phase 3 too:
A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

https://clinicaltrials.gov/ct2/show/NCT03742518?term=samumed

Samumed study could be I don't really understand the graphs, but to me it look like either to maintain or lose hair? even though the write SIGNIFICANT then i can't trace it in the graphs they provided.

 

[Dimmer97]

Samumed study could be I don't really understand the graphs, but to me it look like either to maintain or lose hair? even though the write SIGNIFICANT then i can't trace it in the graphs they provided.

I think the end results were positive. I think it was an average of roughly 10% increase in hair count or growth.

 

[MeDK]

I think the end results were positive. I think it was an average of roughly 10% increase in hair count or growth.

I can't find the 10% growth anywhere, maybe you can provide with some sort of a link?

If I calculate the means from start to the end, then the highest is 5% from 0,15% and 3% from 0,25%

The difference is almost no "shed" from the 0,25% but a huge one from 0,15%. If the graph can be lasted as I do.

Also "A 4 mm scalp biopsy (at leading edge of circumference of balding area within treatment area) was performed on Day -26 (baseline) and Day 91; an optional biopsy was performed on Day 135." I'm no expert, but why take from the edge instead of in the middle of bald area?

Could be because of the chance of higher success rate at the edge of course.

But 5% aren't we talking minoxidil efficiency ?

 

[Dimmer97]

https://www.samumed.com/medium/image/american-academy-of-dermatology-aad-washington-dc_19/view.aspx

 

[Dimmer97]

I can't find the 10% growth anywhere, maybe you can provide with some sort of a link?

If I calculate the means from start to the end, then the highest is 5% from 0,15% and 3% from 0,25%

The difference is almost no "shed" from the 0,25% but a huge one from 0,15%. If the graph can be lasted as I do.

Also "A 4 mm scalp biopsy (at leading edge of circumference of balding area within treatment area) was performed on Day -26 (baseline) and Day 91; an optional biopsy was performed on Day 135." I'm no expert, but why take from the edge instead of in the middle of bald area?

Could be because of the chance of higher success rate at the edge of course.

But 5% aren't we talking minoxidil efficiency ?

Follicle thought posted about it. I believe haircount per 1cm^2 increased from 105 to 115

 

[MeDK]

Follicle thought posted about it. I believe haircount per 1cm^2 increased from 105 to 115

Yes I also got 10% for 0,15% and 7% for 0,25%

They're using a lot of different numbers, why not stay with a number of follicles instead of hair strands? one follicle can have about 3 hairs, and a "bad" one can have about 1 hair.

It would be more interesting for me to see a rise of hair follicles instead of hair strands, of course more healthy hair follicles with more hair strands is also important in their own way.

 

[Dimmer97]

Yes I also got 10% for 0,15% and 7% for 0,25%

They're using a lot of different numbers, why not stay with a number of follicles instead of hair strands? one follicle can have about 3 hairs, and a "bad" one can have about 1 hair.

It would be more interesting for me to see a rise of hair follicles instead of hair strands, of course more healthy hair follicles with more hair strands is also important in their own way.

Yes I totally agree. I guess we gotta wait for phase 3 trials to finish to get more info

 

[tomJ]

Didn't someone on here post a link yesterday about a new tweet or something from Dr. Bhanusali excited upcoming release of a hairloss treatment? Cant find it now. Anyone else see this? Was it taken down?