Follica Pivotal Trial in 2019, FDA Filing in 2020.

Follica update via Puretech’s latest November 2019 presentation. (h/t Toccata). They seem to be calling the product FOL-004. Previously they have used FOL-001, FOL-002 and FOL-003 in various clinical studies. The final name is supposed to be the acronym “RAIN”Note: The unrelated company Follicum labels its hair loss product as FOL-005!

Puretech has now raised its stake in Follica to 78 percent, indicating major optimism.

On page 32 of the presentation, it says that:

  • “Interim clinical readout of optimization study in AGA” was completed in 2019. Checkmark next to it on the left stands for completion.
  • In 2020, the company plans to get “Topline results from pivotal study in AGA” and also go through with FDA filing. Assuming data are supportive.

On page 40, they have a crown hair growth before and after photo. Pretty decent results in my opinion. It says the after photo is 85 days post the “screening” before photo. Not sure how many treatments were required over those 85 days.

The still use the phrase “newly created hair follicles”. Created via the wounding and microneedling procedure using Follica’s proprietary new device.

Apparently, the in-home procedure will just take 5 minutes. Fingers crossed, maybe we will finally get this much touted product to market by the end of 2020.

The below post was published on May 12, 2019. See bottom of page for possible Follica Trial recruitment information.

Follica Clinical Trial Schedule

A few weeks ago, PureTech released its 2018 annual report. On page 31, you can find the summary for Follica. PureTech owned 62.3 percent of Follica at the end of 2018. Follica also updated its site recently as noted by one of this blog’s astute readers last month.

In the above linked PureTech report, the Follica page mentions that the company will start its “pivotal study” in 2019. They have already conducted three clinical trials in the past.

Per one definition, Pivotal study means Phase 3. Per other definitions that I have read, it means Phase 2b. Either way, we are making major progress. Considering that Follica’s methodology involves wounding and then use of existing drug compounds on the scalp, perhaps they can get away with a faster approval process.

I have covered Follica numerous times on this blog, only to be disappointed at its speed of progress each time. However, I have some interesting news to share about the company that I will split between two posts.

Follica Recruiting Volunteers?

While going through their new website in more detail, I noticed that one of their clinical advisers was a Dr. Jeffrey Dover. His was the only name that I did not recognize in the list. A little bit of research, and I found that Mr. Dover works at SkinCare Physicians.

I then went to SkinCare Physicians’ Twitter feed, and lo and behold, the below Tweet from February 14 says it all. I have no idea if this recruitment period is over, but please only call them if you are certain that you fulfill all the requirements, including travel to Chestnut Hill, MA). And do not call them just to ask general questions!

Update: Had to remove the embedded Tweet after a request from one of the company’s representatives. She emailed me and said that they were bombarded with a huge number of calls, with many volunteers not fully realizing the very specific travel requirements. A number of callers even pleaded to get in despite living in different countries! And of course many called just to ask general hair loss questions despite my explicit warning above :-(

How Many Hairs do you Lose per Day?

A popular statistic on the internet is that it is normal to lose over 100 hairs per day. Some even suggest that men and women both shed up to 150 scalp hairs per day. I think that these numbers are excessive for most people who do not suffer from male or female pattern hair loss.

The AAD says that normal hair loss is between 50-100 hairs per day based on a regular cycle. Anything beyond that is excessive shedding and considered telogen effluvium. Such hair loss is usually stress, sickness or fad diet related, and temporary in nature.

Normal Hair Loss per DayBefore I started taking Dutasteride, it was normal for me to see over 150 hairs every day just on my bathtub floor and drain after showering. Even more would be visible on my pillowcase, hair brush after combing, towel and more. In my teenage years, I lost very little hair (less than 20 per day) even if I strongly pulled on each follicle. I also washed and shampooed my hair far less often in my younger days. It was naturally cleaner, manageable and dandruff free.

Please closely read all the options in the below poll before voting.

Poll: How Many Hairs do you Shed Every Day?

Since the poll was slowing down this site, I ended it early. Final results are shown below based on a total of 250 votes:

Hair loss per day poll results.
How many hairs do you lose each day?

Hair Loss Cure News Blog