Follica Hair Loss Treatment for 2019

Today, I wanted to discuss about Follica. Follica is a company based on Boston, Massachusetts that was founded in 2005 and is in the works of developing a treatment system for hair loss in males suffering from androgenetic alopecia. Follica’s regenerative biology platform is based on seminal findings from the University of Pennsylvania that demonstrated the creation of hair follicles in adult mammals after abrasion or commonly known as micro wounds, similar to how a micro needling device works. In other words, it is designed to create new hair follicles and hair through disruption of the skin, followed by a topical treatment to enhance the effect.

Following skin disruption, cells that migrate to help healing are forced to make a decision: should they make epidermis, or should they create new hair follicles? Follica claims there is a window of opportunity in which there are multiple biological pathways to target the formation of new hair follicles known hair follicle neogenesis.

Follica has completed 3 human clinical studies in patients with androgenetic alopecia to demonstrate hair growth and new hair follicle formation and has been optimizing its device and conducting tests in androgenetic alopecia and other aesthetic indications.

Over the years, many people have become dissuaded in Follica due to their years of delay in their work but I am an advocate of their science since wound healing does promote hair growth in multiple confirmed studies.

Follica has preclinical data which show the potential for next-generation proprietary compounds to further enhance the effect of new hair follicle formation from epithelial stem cells, and they completed its clinical stage development of a next-generation device and drug combination product which is currently in an optimization study. Further phases of pre-clinical testing are also ongoing towards the prioritization and development of next generation, proprietary compounds on based on Follica’s intellectual property. Follica’s pivotal study is expected to commence following the completion of the optimization study.

So Follica’s treatment has previously revealed an acronym RAIN, which stands for regeneration, abrasion induced neogenesis, which is a two part process which consists of 1) a non-invasive micro wounding therapy treatment to disrupt the skin and create dee novo hair follicles performed by a licensed doctor, combined with applied compounds which takes place in a clinic and 2) following by a treatment package to be used at home consisting of a topical formula an an application device. The company also has developed a smart phone app to help users keep track of their at home treatment routines as well as enable the device to automatically re-order supplies straight to their house.

Follica targets skin disruption which activates new hair growth, and they found that hair growth effect was demonstrated in humans through their 3 studies FOL-001 to FOL-003 and stimulating wnt pathway amplifies new hair growth effect.

Follica also found a small molecule that is shown to amplify new hair growth during healing and when compared with the control showing a mean of 38 new hairs, the wet (transgenic) showed a mean of 100 new hair, with 25% being terminal hairs per cm2 and the rest vellus hair follicles, but we also don’t know how long the prolonged treatment was for or how many treatments were applied. Was it 1 year of treatment, how many visits to the doctor, etc. Before, they were granted a patent related to FGF9, or fibroblast growth factor 9, which was a key player in the process and when FGF9 was activated, the receptors on the wound sites increased wnt activity and transcript levels. The higher wnt activation in turn increased FGF expression on fibroblasts which initiated a loop in wound fibroblasts that amplified the signaling components required for follicle neogenesis proliferation. But we still don’t have much info on Follica’s proprietary topical compound and they already have a lot of next generation compounds that promote hair growth. But nevertheless, it did increase new hair count and was systemically safe.

Another thing to note is that Dr Dhurat is listed on the company’s website as one of the senior medical advisors as well as Doctor Cotsarelis who is the scientific co-found and advisor. Dr. Dhurat is known for his study of Microneedling with minoxidil 5% which had superior results in terms of hair growth, and Dr Cotsarelis also has studies/patents focused on minoxidil for generating hair growth using micro needling, so minoxidil may likely be one of the proprietary compounds for the topical but definitely will not be the only compound in the topical application.

So obviously, this is going to require an on going treatment to sustain hair growth from the regenerated follicles, and depending on how strongly the new hair follicles grow, it may be necessary to continue to take finasteride or dutasteride to control the levels of DHT and half further hair loss in other areas, but this is just speculation on my part and this is because its a totally different mechanism of action and I feel it may be beneficial if used synergistically. And their wound healing technology is most likely not going to cause any serious side effects such as cancer and I think will likely be much faster to get government approval in comparison to cloning or multiplication type procedures. The interesting thing about Follica is that they are able to have new hair follicle formation through neogenesis AND revive miniaturized hairs according to their patents.

Follica has a 2018 patent for a needling device similar to a Dr Pen as well as their topical medicine application device to be used in conjunction. I’ll leave the link to the patent below for those who want to read about it.

http://www.freepatentsonline.com/20180280675.pdf

I’m no engineer but the way it seems to work is that it is just like a motorized micro needling device and a fluid or drug dispensing applicator for massaging and applying the topical to the scalp. It basically applies compounds while wounding.

Follica expects to initiate the phase 3 study in androgenetic alopecia following completion of an ongoing optimization study in the first half of 2019 So there should be some more updates about the study in this year. Typically, the phase 3 trial is the longest and can range anywhere from 1- 3 years, but I suppose exceptions can be possible for certain treatments, and if the optimization study is completed by this year, we may be able to get Follica’s treatment FDA approved within a couple years, and given the fact that part of this treatment regimen requires patients to go visit a clinic for treatment, it most likely will be affordable to most.

Let me know what your thoughts are on Follica. Obviously this isn’t a “one and done” type of treatment and isn’t meant to fully treat a full bald head, but possibly using it for added coverage with a hair transplant and continuing to increase density with Follica may be a possibility. A hair loss cure would be more likely with Dr Tsuji with hair follicle multiplication combined with subsequent transplantation, but nevertheless I definitely think Follica’s research adds a much needed hard science to the micro needling + minoxidil and healing effect it has on hair regrowth and as you know, I also micro needle using a derma pen to promote hair growth since I know it works and is backed up through multiple studies and science.

There’s still many questions that need to be answered and until we get further news, we won’t know for sure. The question about Follica is not the number of hairs it creates, I think it’s more of whether the process can be repeated to compound the gains and added density in the long run. In the meantime, If you guys are interested, I do sell my new derma pen product  so feel free to check it out. If you have any questions, please make sure to leave me some comments below and we can get a discussion started.