2019 Cassiopea Breezula CB-03-01 Hair Loss Treatment

Today, I have some exciting news to share with you all! If you guys recall, I made a video regarding an Italian pharmaceutical company called Cassiopea and their anti androgen containing composition topical for the treatment of androgenetic alopecia. This topical is called Breezula and I’ll just give a quick re-cap before I dive into the update for Breezula. As we all know, one of the main causes of male pattern baldness is due to the high concentrations of DHT in our scalps, which shorten the hair follicle’s life cycle and eventually miniatures the follicles until they become thinner and thinner and ultimately unable to produce new hair, resulting in baldness.

Breezula topical acts at the cutaneous level on the scalp by blocking DHT interaction with specific hair follicle androgen receptors. It reduces the skin’s production of prostaglandin D2, which is a hormone that can inhibit hair growth, esp if it is elevated in high levels. The good thing about Breezula, unlike current FDA approved hair loss medication such as finasteride, is that it does not interfere with the hormonal and androgenic profile of patients; this means that libido and sexual function are unaffected in clinical trials up to date. This is huge because those who are using finasteride or dutasteride can experience adverse side affects, mainly affecting sexual function and also affects the hormones, where as Breezula does none of that, according to their clinical trials. 

My last update on Breezula was their phase 2 dose ranging trial that took place in Germany. There were over 400 subjects who were enrolled in the trial, and the purpose of the trial was to evaluate the efficacy and safety of four doses of Clascoterone, which is the main active ingredient in Breezula, and it compared to the placebo in males from 18-55 years of age suffering from a Norwood 3 to a Norwood 5, with a historical of ongoing hair loss. The subjects applied clascoterone or the vehicle to balding areas twice a day for 1 whole year. Clascoterone was broken down into 5 treatment groups: they had 2.5% twice a day, 5% twice a day, 7.5% twice a day; a 7.5% solution once a day and a vehicle solution in the evening, and lastly a vehicle solution twice a day. 

The trial was to assess for change from baseline in non-villus target area hair count at month 12, and then the hair growth assessment score at month 12. The target area was one square centimeter. 

The 6 month results shows that the target area hair count was most significant in the 7.5% solution of Breezula applied twice a day and most subjects in all active groups saw an increase in hair growth compared to the placebo group. Even more surprising is that the 7.5% dose twice a day can be compared to the 12 month target area hair count results shown for oral Propecia – At 6 months, 7.5% twice a day of Breezula reached the same efficacy of finasteride 1mg. This is just insane! 

So a couple days ago, we finally got a huge update from Breezula, as they have finally finished their phase 2 12 month clinical trial, and had very positive results in treating androgenic alopecia. The results showed statistically significant improvement versus vehicle for target area hair count for every dose tested as well as directional improvement for hair growth assessment. The results had an excellent safety profile even at 12 months. 

So let’s take a look at their efficacy results at 12 months. Target area hair count was highest in the 7.5% twice. Day group and the hair growth assessment was also seen with most favorable results from the 7.5% dosage. The target area hair width also showed the best results from the 7.5% dosage twice a day at over 762 micro meters and you can see that in the vehicle, it represents the progression of androgenetic alopecia over time if left untreated, as the target area hair count, the target area hair width, and hair growth assessment were all decreasing due to hair loss. 

Safetly results at 12 months was excellent, with no adverse events among patients treated with Clascoterone since it is free from systemic steroid activity. 

This is great news as it means that we are getting closer to a topical that is better than finasteride with no adverse side effects, and it does not alter the hormones. The CEO of Cassiopea plans to meet with FDA mid year to discuss their phase 3 clinical trials in men which is expected to start towards the end of 2019. They are also looking into expanding this for treating women hair loss so this is also good news for women suffering from hair loss. If Breezula is approved, it would be the first topical anti androgen for the treatment of androgenic alopecia since 1997. So I am very excited about this, and hopefully it pulls through and replaces the current hair loss medication we currently have. If every goes as planned, I am expecting that they release this to the market in the next 2-3 years. Let’s keep our fingers crossed and hope for the best news.