BREEZULA Phase 3 Clinical Trials Delayed Due to Corona Virus (COVID-19)
Hey guys, what is going on? Welcome to my website HAIRLICIOUSLY. If you are new to the channel, make sure to hit that subscribe button (on Youtube) to stay updated on hair loss topics and my 2nd hair transplant journey update. If you haven’t seen my previous video, the clinic that I went to get my hair transplant in South Korea, Motion Clinic, is offering a 51% discount for anyone who is able to travel to Korea before mid April. I know that the majority of my viewers are from the US and if you are a US citizen or green card holder, you are still able to go in and out of the country with the ongoing COVID 19 situation. I wouldn’t recommend it, as It’s obviously a risk to travel right now, but due to the tanking economy all over the world, a lot of businesses are trying to offer enticing offers and this is probably one that you will never see happening because a 51% discount is a pretty big chunk. And it’s even better if you’re already in Korea and looking to get a hair transplant, now would be the best time in terms of cost. I’m not recommending anyone to do so, but just throwing it out there in case anyone was interested. You guys are old enough to make your own decisions but I’ll leave the contact info in the description box for those who are interested in getting a complimentary consultation with Motion Clinic.
I wanted to give you guys an update on one of the hair loss treatments that I have been following very closely over the past few years. This is one that could truly revolutionize the hair loss industry and replace current mainstream hair loss treatments like finasteride and minoxidil that have been around for decades. By now, most of you should know or at least heard of Breezula. Breezula is a topical hair loss treatment in the works by the Italian pharmaceutical company Cassiopea. It used to be called CB-03-01 for their developmental code name but they changed the name to Breezula, and their main compound in this topical anti-androgen is Clascoterone.
Breezula works at the cutaneous level on the scalp by blocking DHT interaction with specific hair follicle androgen receptors. It’s known to reduce prostaglandin D2, which is a hormone that can inhibit hair growth, esp. if it’s elevated in high levels. The wonderful thing about Breezula and the reason why so many people are interested in this topical is because it does not interfere with the hormonal and androgenic profile of patients. This means that libido, sexual function, brain fog, and any other conditions that are known to cause side effects due to hormonal changes were not found in the clinical trials up to date. We all know that a lot people suffering from hair loss are hesitant to take finasteride because of these side effects and something like Breezula can stop that while helping you maintain and even regrow hair afflicted by androgenic alopecia.
The last update we got from Breezula was on their phase 2 completion dose ranging trial that took place in Germany last July. Results were extremely positive after 12 month phase 2 trials. In a nutshell, people between a NW3 to a NW5 applied various doses of topical Breezula and it was confirmed that the best dose for maximum hair growth was at 7.5% solution applied twice a day. Basically, 7.5% dose twice a day was comparable to the 12 month target area hair count results shown for oral finasteride, at just 6 months of 7.5% twice a day of Breezula. So literally, it reached the same efficacy of finasteride 1 mg in just 6 months and without the side effects which is insane.
At 12 months, there was 14.3 new hairs per cm2 as well as target area hair width increase which is all positive and exciting news.
Cassiopea was planning to proceed with a 6 month phase 3 clinical trial towards the end of last year, after consulting with the FDA but that has been delayed due to the corona virus pandemic.
As you know, Italy has been hit pretty hard with COVID and the last time I checked, there has been over 50,000 cases of confirmed corona virus patients with nearly 5000 deaths. The number of infected people is just growing exponentially in Italy and the reason behind this is that Italy has the second oldest population in the world, and that means that younger people need to tend with the elderly, like their grandparents, which means more exposure to the virus. With a full lockdown in place in Italy, it definitely will delay Breezula from starting phase 3 clinical trials and until we have a better understanding and control of COVID, I can’t speculate when Breezula will be available, and there is a good possibility that phase 3 trials will not even begin until early next year. The good news is that Cassiopea already has other products that use the compound clascoterone in different dosages, for example, for the treatment of acne, which has already gone through phase 3 and NDA acceptance by the FDA for August 2020. There’s also clascoterone female pattern hair loss phase 2 trials that are supposed to be completed sometime mid to late 2020. The newsletter also states that once approved, Breezula is expected to be priced around $100-$200 per month, which is still expensive, but considering that it is effective at regrowing and maintaining and without side effects, it wouldn’t be too farfetched in my opinion.
It’s been pretty bad at my workplace as well. Working in a law enforcement environment, my job operates 24/7. There has been confirmed corona virus cases at my work as well, as as we speak, I actually came in contact with someone with COVID, so I had to go to the hospital to get tested. If you guys are looking to get tested, some hospitals do offer testing but it is limited since they don’t have the full resources to test anyone. I was lucky enough to get tested since my wife is pregnant but if you do not show any symptoms, I do not think they will test you. There are also facilities you can go to once you have a doctor’s prescription. They did a mouth and nasal swab and sent it to the lab to get tested and I’ll find out within the next 6 days or so. I didn’t show any symptoms and it’s already been day 10, but since COVID can be asymptomatic, I still wanted to get tested so that I don’t risk my family or those around me. And It’s nerve wracking because it’s not like you can shut down a facility that operates 24/7, esp. when you have to vet international travelers entering in the US from high risk countries, so as CDC recommends, the best thing you guys can really do is to practice social distancing, washing your hands as often as you can for at least 20 seconds, wearing a mask, and limiting social interaction with others.
And until this settles, the economy will continue to collapse, many businesses will be bankrupt, and many companies that are currently researching for better hair treatments will get delayed. And this applies to any other current mainstream hair loss companies that are researching. Everything is on standby and until we, as a nation, are able to either find a vaccination or quarantine this completely, it’ll be difficult to get further updates as far as clinical trials.
Also, if you guys are interested in regrowing hair, look into micro-needling and low level laser therapy. Micro-needling at a length of 1.5mm 1x a day with 5% minoxidil 2x a day, and using low level laser therapy has been shown to promote hair growth and a lot of people have seen great results.
Anyway, that’s all I have for you guys today. If you have any questions, make sure to leave me some comments in the comment section below, or you can reach me via email which is in the contact page on my website hairliciously.com. Thanks for watching, stay safe, and I will talk to you guys next time. Take care!
Hey! Been watching you for years now! Best way to stop shedding and grow thicker hair!? Also, how can i buy breezula is it that affective?
I have a concern about the longer-term effectiveness of this drug. The Phase 2 results show that while the 6 month results were great (Hense equivalent to Finasteride) they then plummeted by month 12. For all we know this drop could continue. I don’t know if this is due to an upregulation in androgen receptors or what but it’s a little disheartening.
What’s also misleading is that they’re measuring hair counts against placebo rather than baseline, hence you may still lose hair after a year but not as much as you otherwise could of.
I’m not putting it down completely, being the first FDA approved drug for androgenic alopecia since the 90s is monumental in itself. However, it doesn’t seem we’re looking at a long term solution for those who can’t tolerate finasteride.
You said microneedling 1x a day with 5% minoxidil 2x per day but don’t you mean micro needling 1x per week?