Category Archives: Minoxidil

Follica Pivotal Trial in 2019, FDA Filing in 2020.

Update: December 19, 2019 — Follica just announced positive topline data from its latest clinical study for androgenetic alopecia. There was a significant 44% improvement over baseline in visible (non-vellus) hair count totals after 3 months of treatment. The final Phase 3 study is expected to commence in the first half of 2020. Quotes from Jason Bhardwaj and Ken Washenik in there.

They did not mention which topical drug was used. However, I would not be surprised if it is just Minoxidil, based on the further below mentioned findings from last month. Hopefully, once the treatment is on the market, they can add more compounds into the mix without needing to go through clinical trials each time. A key quote mentions the use of an “on-market” drug, so no fancy newly developed products for the time being:

“Follica’s proprietary in-office treatment regimen combines targeted scalp disruption using the Follica Hair Follicle Neogenesis (HFN) device, with a topical on-market drug to create and grow new hair follicles.”

Hair Follicle Neogenesis (HFN) and Skin Disruption

One unusual section of the above press release mentions a comparison with other skin disruption devices on the market. The Follica HFN device “significantly outperforms other skin disruption devices” when it comes to hair follicle neogenesis.

However, this seems to imply that using any kind of skin disruption  device can cause at least some brand new hair follicle growth. I am beginning to think that I should start microneedling and dermarolling like tens of thousands of other people.

Follica Might Start off with Minoxidil

Update: November 25, 2019

A few days ago, “Toccata” emailed me a pdf document in which one small part mentioned that Follica was going to use Minoxidil as the compound after the microneedling. Reference: How does Minoxidil work to grow hair?

Apparently, this document was also posted on several hair loss forums. However, no-one initially saw the page 46 small Minoxidil part except “Toccata” as far as I could tell. The new HLT thread on last week’s Follica news is already 10 pages deep. At this point, it seems like a few people have realized what was missed before and the pdf has been repasted several times.

I did not want to share this document right away. On Twitter, I first asked several members of the Follica team to contact me as I wanted permission to share the cartridge, dropper and new patient hair growth photos. In the past, several Follica staff members have responded to my requests and questions.

However, I got no response from anyone this time around despite two attempts on November 21 and 22. I did not mention anything about Minoxidil to them, so there must be another reason for the secrecy.

I have now found the same document available online here. On page 46, it states: “Proprietary Minoxidil cartridges for use with smart dropper”. Crazy to see this after years of speculation.

For many years, most of us have assumed that Follica would use a compound that would at the very least be Minoxidil PLUS something else. Many people assumed that the second compound would be based on valproic acid, since Follica even has a patent in that area. So this news is a disappointment.

However, two important points to note:

  1. The above linked conference call pdf was published around three years ago and is old news. Moreover, things may change further before the end of 2020.
  2. It will be much easier to get initial US FDA approval for a microneedling based treatment that only involves the addition of Minoxidil. After all, topical Minoxidil has been approved as a hair loss treatment for decades. Some people even take the more dangerous oral Minoxidil to treat their hair loss.

Correct microneedling and wounding in combination with Minoxidil seems to give excellent results (e.g., see Rachita Dhurat and her India microneedling work). Most people who are experimenting with at-home microneedling are not doing it correctly. Hopefully, Follica’s micro-needling device in the hands of a professional will be much superior.

Even more hopefully, Follica will add other compounds into the mix down the road. Perhaps even something like wounding plus mesotherapy with Dutasteride.


November 21, 2019

New Follica update via Puretech’s latest November 2019 presentation. (h/t “Toccata”).

Follica FDA Filing in 2020

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 Follica “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.
Follica Hair Growth Results
Follica FOL-004 Hair Growth in Crown.

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 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.

Puretch Pipeline

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.

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 Does Minoxidil Work to Grow Hair?

How does Minoxidil work in growing hair on a receding hairline? The below post was originally written in 2014. It has now been updated with newer studies discussing Minoxidil’s mechanism of action in stimulating hair growth.

Minoxidil Foam.
Minoxidil foam to grow hair.

Minoxidil (brand name Rogaine) is known to be one of only two medications officially approved for hair loss treatment. With the other being Finasteride (Propecia). It is available in 2% and 5% dosages and in topical and foam versions. Besides Rogaine, another well known Minoxidil brand is Costco’s Kirkland.

Minoxidil was first approved by the US FDA to treat male pattern baldness in 1988. In 1991, the product was also made available for women with female pattern hair loss and thinning hair.

Make sure to read my post on whether Minoxidil can grow a beard. A large number of people are using this product to gain facial hair, not something I would recommend. Also see some before and after results of Minoxidil and Finasteride to regrow hair.

How does Minoxidil Work?

Scientists do not know the exact mechanism via which Minoxidil® (a mitogenic drug) has a positive effect on hair growth. However, there are a number of proven mechanisms of action that suggests how Minoxidil works to stimulate hair growth.

Minoxidil Chemical Structure.
Minoxidil Chemical Structure.

The original use of Minoxidil was as an oral medication for high blood pressure. See my post on oral Minoxidil. The side effect of hypertrichosis (excessive body hair) led to its becoming a popular treatment option for hair loss.

To date, the main theories about how Minoxidil works to grow hair are:

  • Due to its vasodilation effect.
  • Due to its potassium channel opening effect.
  • Via inhibiting the decrease in calcium levels in cells. This prevents the inhibition of epidermal growth factor stimulated hair root growth.
  • By increased blood flow to the scalp.
  • By increasing key growth factors that are conducive to scalp hair growth.

There are also other theories about how Minoxidil (aka Rogaine) helps scalp hair growth. Further below, I outline all of the main ones.

Besides prolonging the growth phase of the hair cycle, Minoxidil has also been shows to increase the diameter of existing hair follicles. According to a study from 1988, seven subjects who received a 5 percent dose of minoxidil had a mean hair shaft diameter of 0.029 mm before treatment. This hair width then increased to 0.043 mm at 12 weeks.

It should be noted that Minoxidil can grow hair on both the crown (vertex) and frontal regions of the scalp. Many people think that it only works in the crown area, but that is incorrect.

History of Minoxidil

  • In 1979, Minoxidil was first approved by the US FDA. However, its usage was as an oral blood pressure medication (brand name Loniten) rather than as a hair loss treatment.
  • In 1988, the FDA first approved Minoxidil as a hair loss treatment. This was via a topical 2% solution formulation under the brand name Rogaine, owned by Upjohn Company. However, Rogaine was only available via prescription, and it was only meant for use by men.
  • In 1991, the FDA approved Minoxidil as a hair loss treatment for women, but by prescription only.
  • In 1992, Rogaine launched a 2% Minoxidil topical solution for women, only available via a prescription.
  • In 1996, the FDA approved the over-the-counter sale of 2% topical Minoxidil and also allowed the production of generic formulations of Minoxidil. Upjohn subsequently drastically cut the price of Rogaine in order to compete in the now much more competitive market.
  • In 1997, Upjohn released a 5 percent topical solution formulation of Rogaine. It was only available by prescription and for men only.
  • In 1998, the FDA approved a 5 percent formulation of Minoxidil for over-the-counter sale to men.
  • In 2006, Rogaine launched a 5% Minoxidil foam product for the first time. It was immediately available for over-the-counter purchase, but only recommended for men.
  • In 2011, men’s Rogaine foam was made available in unscented format.
  • In 2014, Women’s Rogaine 5% Minoxidil foam was approved by the FDA, but with a once a day treatment recommendation. Men are always supposed to use Minoxidil twice a day.

Mechanism of Action (References and Studies):

  • In 1997, researchers found that Minoxidil increased prostaglandin synthesis (more specifically, prostaglandin synthase-1, abbreviated as PGHS-1) in cultured dermal papilla cells. In more recent years, the issue of prostaglandins and hair loss has garnered a great deal of attention and you can search for “PGE2” on this blog to learn more.
  • A French study from 1998 is among many that has found that Minoxidil upregulates growth factors, in particular vascular endothelial growth factor (VEGF).
  •  A 2001 study found that the positive effect of Minoxidil on hair is mediated by adenosine.
  • An excellent article from 2008 on hair loss medical treatments by Dr. Nicole Rogers and Dr. Marc Avram that discusses Minoxidil in detail. They mention that one of the main effects of Minoxidil is angiogenesis and increased blood flow in the area of application. They also discuss the enhanced cell proliferation and DNA synthesis effects on Minoxidil that might be benefiting hair growth.
  • In 2011, South Korean researchers found that Minoxidil activated the β-catenin pathway in human dermal papilla cells and therefore extended the anagen (growth) phase of the hair cycle.
  • In April 2014, Taiwanese researchers came up with yet another reason as to why Minoxidil works, concluding that it may suppress androgen receptor-related functions. i.e., the drug has anti-androgenic properties. Their conclusion is especially interesting:

The current findings provide evidence that minoxidil could be used to treat both cancer and age-related disease, and open a new avenue for applications of minoxidil in treating androgen-AR pathway-related diseases.

Minoxidil enhances hair keratinocyte proliferation and activates hDP cells to induce growth factors. IGF-1 is among these growth factors, and has been shown to exhibit a potent hair elongation effect.

  • In June 2017, US researchers published a new study that provided significant insights into how Minoxidil foam worked via upregulating and downregulating various genes. Interestingly, vertex and frontal scalp of patients showed a generally similar response to Minoxidil. Many online reports suggest that minoxidil might work better in the crown than in the front, but perhaps that is not true based on these findings.
  • In February 2018, South Korean scientists discovered that Minoxidil promotes hair growth through the stimulation of growth factor release from adipose-derived stem cells. This growth factor secretion may enhance hair growth by promoting dermal papilla cell proliferation.

Minoxidil Side Effects

In general, topical Minoxidil is well tolerated in most people at the typical 5% dosage. Most people even tolerate higher concentration levels of the drug. However, some people will get side effects.

The most common entail adverse skin reactions such as burning, itching, redness and stinging in the areas of application. Another common complaint is an increase in body hair growth after taking Minoxidil, especially in the forehead, eyebrow and beard regions.

In rare instances, people complain about dizziness or breathing difficulties after taking Minoxidil. Allergic reactions, including rashes, are also possible in some cases. Please see a doctor immediately if you get such serious side effects. Also make sure to stop using this medication right away.

Rogaine Shedding

Some people will shed a lot of hair after changing their Rogaine (Minoxidil) dosage. For those who quit Rogaine entirely, a major shed of scalp hair is almost always guaranteed. Sometimes this can take weeks or even months after drug use cessation. In many instances, sheds are temporary and just a regular part of the hair growth cycle. i.e., anagen, catagen, kenogen and tologen.

Toxicity in Cats and Dogs

If you own pets, note that Minoxidil is very poisonous to some animals, especially cats. If your cat is exposed to Minoxidil via a spill or accident, some side effects to look out for include:

  • Fatigue and lethargy.
  • Changes in heart rate due to cardiac damage.
  • Dehydration.
  • A drop blood pressure (hypotension).
  • Coughing.
  • Changes in appetite.

Prompt action and treatment by a veterinarian will prevent your cat from dying. If the medication was applied topically, make sure to wash the cat’s paws and fur promptly and thoroughly.