A new age for hair loss prevention. Breezula the new hope for hair loss.

Categorized as Hair Care Tagged ,
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Last Updated on March 13, 2021 by Rei Ramos

Cassiopea

Cassiopea the company that is developing a new drug that if approved would change the game in hair loss prevention.

The basics

Androgenetic alopecia (AGA), or most commonly called male pattern baldness, is a common genetically determined hair disorder that can affect both men and women. AGA affects 50% of men and 13% of premenopausal women and greatly increases in postmenopausal women. Our hair normally grows in cycles of 2 to 6 years, but with people who are suffering from AGA, these cycles are shortened to 6 to 8 months. Over time these hairs become miniaturized and get progressively thinner and shorter.

The primary cause of this hair miniaturization process is the sensitivity of the scalp to the androgen called Dihydrotestosterone (DHT). DHT is made from testosterone via the enzyme 5 alpha-reductase. This androgen is important in developing external genitalia on male fetuses, but DHT has shown no beneficial effect in adult men. However, DHT only does two things when we’re older — hair loss and prostate gland enlargement. That’s why currently, the primary weapon we have against fighting hair loss is a medicine created for enlarged prostate called finasteride (more on this later!).

What is Cassiopea trying to do?

Cassiopea is trying to develop a drug that would potentially add an additional arsenal for our fight against hair loss. Currently, we are very much limited on how we can fight hair loss, the only 3 main things we can try that are FDA approved are finasteride, minoxidil, and ketoconazole shampoo or what is commonly called the big 3.

Ketoconazole shampoo or its most popular brand name Nizoral is said to reduce inflammation in the scalp. While minoxidil originally used for hypertension is a topical solution that works by widening blood vessels and allowing more nutrients of the hair follicles. And Finasteride the key to fighting male pattern baldness works by blocking the action of the enzyme called 5-alpha-reductase, this changes the testosterone to another hormone that causes the prostate to grow or cause hair loss in males.

Now, this all sounds great, right? We have finasteride that blocks the main culprit that causes hair loss, and we have minoxidil that basically revives weak hair follicles. We also have ketoconazole that would help with reducing scalp inflammation. Then why do we need another drug, you ask, because finasteride is a drug that reduces DHT on the whole body. In comparison, the drug that Cassiopea is trying to make is a topical solution that could be applied directly to the scalp and would only block DHT that is on the hair follicle itself.

Why do we need a topical DHT blocker?

Currently, a lot of people are afraid of taking finasteride because of the potential side effects. The potential side effects of finasteride include:

  • Impotence
  • Loss of interest in sex
  • Trouble having an orgasm
  • Abnormal Ejaculation
  • Swelling in your hands of feet
  • Swelling or tenderness in your breasts
  • Dizziness
  • Weakness
  • Feeling like you might pass out
  • Headache
  • Runny nose
  • Skin rash

As you can see this side effects are very scary specially the sexual side effects.

PROPECIA (N = 945)Placebo
N=934
Decreased Libido1.81.3
Erectile Dysfunction1.30.7
Ejaculation Disorder
  (Decreased Volume of
Ejaculate)
1.2
(0.8)
0.7
(0.4)
Discontinuation due to drug-related sexual adverse experiences1.20.9
Drug related adverse experience for Propecia(finasteride 1 mg) in Year 1 for male patern hair loss

In April 2012, the FDA issued a warning on finasteride. It stated that sexual side effects could persist even after stopping the medication. Those side effects include decreased sex drive and ejaculation problems. The warning was based on about 100 reports the FDA received over nearly 20 years. 

As men are the primary affected by AGA, this becomes a real fear because we have to decide if these side effects are worth keeping your hair. But studies show that side effects caused by finasteride are extremely rare. In three controlled clinical trials for Propecia(Brand name of finasteride) of 12-month duration, 1.4% of patients taking Propecia (n=945) were discontinued due to adverse experiences that were probably or definitely drug-related.

As you can see, although it is very rare, the risk is also real, so we want to do whatever we need to reduce this chance of developing side effects. That’s where the topical DHT blocker Breezula comes in. Because this is a topical solution, the effects can be localized in the scalp, reducing the potential for side effects, unlike its counterpart, finasteride that goes systemic with its effects.

Does breezula works as good as finasteride?

According to Cassiopea, phase 2 of the twelve-month result for Breezula(Clascoterone) in treating AGA is very positive. According to them, a 7.5% dose of Breezula has the same effects as 1 mg oral finasteride. That result was outstanding considering that Breezula is a topical antiandrogen that will have a much lower side effect than its counterpart finasteride.

Another thing to consider when comparing these two is the ease of use. While the side effects of finasteride are real, it is extremely rare. And for a user of finasteride who wants to switch to Breezula when it eventually comes out, they would have to consider that they need to apply Breezula 2 times a day for it to have the same effects as a 1 mg a day tablet of finasteride. So for the folks out there currently taking finasteride and are not having side effects, it would not be beneficial to switch considering the extra hassle of applying a topical two times a day.

And good news for women suffering from AGA, Breezula is much safer compared to finasteride. Finasteride is not recommended for women who are pregnant or trying to conceive. Studies show that men should not take finasteride when trying to conceive.

When will breezula be released?

According to a press release by the CEO of Cassiopea, Diana Harbort they are currently on phase 3.

“We are very pleased by these excellent results which show that our topical anti-androgen is efficacious in the treatment of AGA with side effects similar to placebo and importantly without any systemic side effects. Based on these results, we plan to meet with the FDA mid-year to discuss the planned six-month Phase III trials in men. Hopefully, we will begin our Phase III program in 4Q 2019. We also plan to begin – as soon as practicable – a POC study in women, which would enlarge significantly the potential of the product. The global hair loss market is very large and very underserved with only OTC products and generic therapies available, therefore this product, if approved, could serve a global audience.” 

Diana Harbor – Cassiopea CEO

As of now we are currently waiting for another news for this amazing new drug. If approved breezula would be the first new approved drug for hair loss since finasteride in 1997.

Closing thoughts

The fight for hair loss is a losing battle, but with news like this, that shows promising results, maybe we don’t have to give up so easily. Evidence shows that experiencing hair loss leads to personal, social, and work-related problems. People with severe hair loss are more likely to experience psychological distress than those with mild hair loss. Nobody wants to admit it but losing your hair, especially at such a young age, is really depressing. Everyone would tell you to “just shave it” and “just be confident,” and you would be fine. But what they don’t understand is the mental effects hair loss does on us. It’s really depressing seeing your peers with perfect hair and comparing yourself to them and thinking, why can’t I have that. And it’s true that some people actually look good bald, but not everyone can have the perfect head shape to pull it off.