FOLLICA FOL-004 UPDATE + FDA FILING IN 2020!
I wanted to finally give you guys an update regarding Follica. Follica has been around for quite some time and to give you a brief overview of the company, Follica’s main focus revolves around creating micro wounds on the scalp to create new hair follicles through disruption of the skin, followed by a topical treatment to enhance the effect.
Over the years, a lot of people have lost faith in Follica since they have delayed a lot of their work with no progress but as you guys know, I am a strong advocate in wound healing through microneedling and a lot of people have seen great results with confirmed scientific studies so Follica is high up on my list of companies that I expect to share good results in terms of treating genetic hair loss.
Follica’s treatment previously revealed the acronym RAIN, which stands for regeneration, abrasion induced neogenesis, which consists of 2 parts: 1) a non-invasive micro wounding therapy treatment to disrupt the skin and create de novo hair follicles per formed by a licensed doctor, combined with applied compounds which takes place in a clinic and 2) a treatment package to be used at home which consists of a topical formula as an application device.
So far, Follica’s hair growth effect was demonstrated in humans through 3 studies FOL-001, FOL-002 and FOL-003, but a few weeks ago, we received an update regarding Follica’s results from FOL-004 treatment which shows before and after photos from an optimization study they had conducted for their hair growth therapy treatment. This is exciting since this is the first time that Follica has shared before and after hair growth results. So the presentation shows sample patient outcome from FOL-004 interim data.
We already know this process consists of going in the clinic but Follica states that they are developing a relatively short procedure with limited downtime, precisely a 5 minute in office procedure. We also know that they will be operating a proprietary device designed to stimulate hair growth along with a pharmaceutical compound to thicken and maintain newly created hair follicles. We still don’t know what this topically applied compound consists of but as far as the device, we know it will be similar to how a microneedle operates. I’m just curious to see exactly what compounds are going to make up for this topical. It also makes me wonder if this topical can show better results than current minoxidil and microneedling results, since many people use this combination at home to stimulate and promote hair growth.
Interim data from an ongoing safety and optimization study (20 patients) showed that it achieved a statistically significant increase in non-vellus hair count after 3 months of treatment compared to baseline. Blinded head to head bench testing of Follica’s device showed advantages to scalp treatment versus commercially available skin disruption devices. This statement shows it works even better than current microneedling devices, so that is also good. I wonder if it has something to do with the depth or number of needles.
Lastly, topline results from pivotal study and subsequent NDA filing with the FDA, if data is supported, are expected in 2020. This is great news as it finally shows progress towards possible commercialization.
Let’s look at the before and after photo they provided and see what kind of growth we are seeing. In the before photo on the left, we can clearly see a pretty good sized bald spot on the crown. 85 days later with Follica’s treatment (and note, it doesn’t specify how many treatments were done during the 85 day period), the bald stop has significantly reduced and we can see that new hair growth has grown in on the bald stop.
The angle from the two photos aren’t the same but it is clear that new hair growth and density has filled in. For 3 months of treatment, this is pretty amazing. However, it would’ve been a lot better if these treatments showed any results on the temples and hairline, since most hair loss suffers start from receding hairlines and it would’ve been really beneficial if we saw any compelling before/after results. But nevertheless, this is pretty exciting but nothing extraordinary because I’ve seen similar if not better results from people on finasteride or minoxidil and microneedling but like I said, different options are always a good thing and perhaps this may not come with side effects unlike some people who can’t take certain hair loss drugs as a result. This is by no means a cure for hair loss but rather another maintenance type of treatment to bolster existing hair and possibly to regrow some hair that has been lost through miniaturization.
It would also be good to see some before after photos of just using Follica’s proprietary device vs using just their pharmaceutical compound, just so that we can see how effective each one of them area when used independent of each other.
In conclusion, this is exciting but nothing over the top since #1 it isn’t going to cure hair loss, #2 similar results were seen from current hair loss meds, #3 after a decade of research, this being their result is somewhat mediocre but like I said, I want to remain optimistic and hopefully better results will follow after long term treatment with minimal side effects.