Magnifico! Breezula from Italy Achieves Positive Results in Phase II Trial

It was nearly 22 years ago that the FDA approved Propecia (finasteride) to slow or stop the rate of hair loss and regrow hair. That was the last time the FDA approved a medical treatment for hair loss, which is pretty amazing considering the flurry of discoveries related to hair loss and hair regrowth we’ve been tracking in recent years.

The latest promising advances are coming from a small company in Italy,Cassiopea, which just reported positive findings from its phase II clinical trial of Breezula®, known generically as Clascoterone. The study of 400 men ages 18 to 55 examined how different dosages of Breezula performed in terms hair count and looks. It included a control group that were given a placebo as well.

What they found was promising. The higher the dosage the better the results, and Cassiopea reported no serious treatment-related adverse events among the patients treated. That’s important, because a portion of the men who take finasteride experience unwanted side effects, and women who are of child bearing age are warned not to take the drug.

So far, studies to date have found that Breezula does not interfere with the hormonal profiles or testosterone profiles of male subjects. There have been no reports of changes in libido or sexual behavior in the clinical trials completed so far. If Breezula proves to be equally or more effective than finasteride without the side effects, that will be an important advance.

Drilling down into the data, there were three different things being watched: the progression of male pattern baldness, the regrowth of hair and ‘hair growth assessment,’ which basically is what the subject thinks of their hair. The four dosages being tested were 2.5 percent solution applied twice daily, five percent solution applied twice daily, 7.5 percent solution applied twice daily and 7.5 percent solution applied once daily.

While all four groups who were treated with Breezula reported that hair loss slowed, there was marked improvement among the higher dosage (5 percent and 7.5 percent) groups. Perhaps equally exciting is that it worked relatively quickly, with statistically significant results starting at their 3-month checkups.

As for hair thickness, the results were also positive, but it took slightly longer to materialize. Only the group treated with 7.5 percent solution applied twice daily reported statistically significant results after three months. It took the others six months to reach that point. The thicker hair that resulted from the application of Breezula was sustained over the entire 12 months of the study.

Finally, the subjective assessment of how the subjects felt about their hair also came out positive for Breezula. About three out of five of the test subjects felt better about their hair. Interestingly, half of the placebo group also felt better about their hair, apparently tricked into thinking the substance they were rubbing into their scalp was doing something when it actually was not!

So what is Breezula? Like finasteride, it is an anti-androgen. Unlike finasteride, which is taken orally, Breezula is applied directly on the scalp to penetrate the skin. When it soaks in, Breezula reaches the androgen receptors within the sebaceous glands and hair follicles. The primary cause in male and female pattern hair loss is that high local concentrations of dihydrotestosterone (DHT) bind to androgen receptors within the scalp hair follicles, so Breezula works by blocking DHT interaction with the specific hair follicle androgen receptors.

Phew, that’s pretty complicated!

The bottom line is that Breezula would be the only topical antiandrogen approved for use in pattern hair loss that could be used by both men and women.

“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,” said Diana Harbort, CEO of Cassiopea, in a news release. “Based on these results, we plan to meet with the FDA mid-year to discuss the planned six-month Phase III trials in men.”

Harbort says the plan is to begin the Phase III program before the end of this year. Additionally, she laid out plans to begin studying the safety and effectiveness of Breezula in women.

Before wrapping up we at Arocha Hair Restoration want to be clear that the vast majority of men we treat with finasteride do not experience side effects. Statistically, more than eight out of ten men treated with finasteride see hair loss slow or stop and about two thirds experience hair regrowth. Even so, we are hopeful that sometime in the 2020s Breezula will become an additional option in our arsenal to help the small percentage of men who do experience side effects. If it proves to also be effective in women, that will be a major step forward for the hair restoration community!