Since the arrival of minoxidil in the 1980s and finasteride in the 1990s, no treatment for baldness has raised so many expectations. Tested on more than a thousand volunteers, Breezula, a hair lotion based on clascoterone, is now presented as a potentially better tolerated alternative. But what can we really expect from it? Are we facing a therapeutic revolution or a measured advance? Decryption, with the insight of Dr Gérald Kierzek.
Baldness: a frequent fatality with very real psychological consequences
Baldness, or androgenetic alopecia, affects between 50 and 70% of men during their lifetime. It often begins early, sometimes as early as the thirties, and progresses gradually. The cause is a genetic sensitivity of hair follicles to dihydrotestosterone (DHT), a hormone derived from testosterone. Under its influence, the follicles shrink, the hair growth cycle shortens, and the hair becomes thinner until it disappears in places.
“We must understand that baldness is not a disease in the strict sense, but an extremely common hormonal and genetic phenomenon”explains Dr. Gérald Kierzek.
“It is not dangerous for health, but its psychological impact is often underestimated. Many men experience this loss as premature aging or a direct attack on their image.”
On a medical level, one point is fundamental: “Androgenetic baldness is not reversible when the follicles are destroyed. No treatment, today, can recreate a missing hair follicle. Existing treatments aim to slow down the progression and densify what can still be.”
Minoxidil and finasteride: useful but imperfect references
For more than thirty years, medical treatment of baldness has essentially been based on two treatments. Minoxidil, applied topically to the scalp, acts by improving local vascularization, which promotes the supply of nutrients to the follicles. It can stimulate moderate regrowth and slow down hair loss, provided it is used daily and over the long term.
Finasteride, for its part, acts further upstream of the hormonal mechanism. Administered orally, it blocks the transformation of testosterone into DHT. “It is an effective treatment in certain patients, especially in the early stages”recognizes Dr. Kierzek. “But its main obstacle remains the fear of side effects.”
Reduced libido, erectile dysfunction, mood changes, and even suicidal thoughts have led European authorities to reinforce warnings. A topical version of finasteride has recently emerged to limit these effects, without resolving all the questions. And above all, reminds the doctor: “Whatever the treatment, as soon as it is stopped, the fall starts again. There is no definitive cure.”
Breezula: a new anti-hormonal approach, but local
It is in this context that Breezula arouses so much interest. This experimental treatment is based on clascoterone, a local anti-androgen applied directly to the scalp. Its objective is simple: to prevent DHT from attaching to the receptors of hair follicles, where it exerts its deleterious effects.
“Breezula is not a miracle cure”immediately tempers Dr. Gérald Kierzek. “It’s a topical lotion with 5% clascoterone, which locally blocks DHT receptors. The idea is to work exactly where the problem is, without exposing the whole body to hormonal inhibition.”
Unlike oral finasteride, the product is designed to remain primarily local, with minimal systemic absorption. It is this point which explains the current craze because many men today refuse oral treatments for fear of adverse effects.
Encouraging results, but to be interpreted with caution
Developed by the Cosmo Pharmaceuticals laboratory, Breezula was evaluated in two phase III clinical trials including approximately 1,465 men suffering from mild to moderate alopecia. For several months, participants applied the gel twice daily, while a control group received a placebo.
The data reported show a significant increase in hair density in the treated areas, significantly greater than that observed in the placebo group. “The figures speak of sometimes very high relative improvements, up to several hundred percent compared to the placebo”explains Dr. Kierzek. “But we must be very clear: this does not mean that patients regain a full head of hair.”
In reality, Breezula seems to be able to strengthen existing hair and slow down the miniaturization of still active follicles. We are talking about densification and stabilization, not spectacular transformation. “A man who is already very bald will probably not benefit from it.”
Tolerance: a key point for long-term treatment
In terms of safety, the results so far have been reassuring. The adverse effects observed are mainly local, such as slight irritation or transient itching of the scalp. No significant systemic hormonal effects were demonstrated in the trials.
“This is a fundamental point”emphasizes Dr. Kierzek.
“A treatment against baldness is necessarily a long-term treatment. If it is not well tolerated, patients stop it. The fact that Breezula seems to act locally without a global hormonal impact is, at this stage, a real positive point.”
Despite the enthusiasm, experts urge caution. Breezula will not replace minoxidil, finasteride, or hair transplantation in advanced stages. “It is more of a complementary treatment, particularly interesting in men in the early stages of baldness or in those who do not tolerate oral treatments,” summarizes Dr. Kierzek.
When will Breezula be available in France?
The treatment is not yet commercialized. Health authorities must examine all the data before issuing a marketing authorization. The usual deadlines suggest a possible arrival in Europe around 2027, at best.
Until then, doctors warn against products sold online under the name Breezula. “They do not correspond to the medicine evaluated clinically and may be ineffective or even dangerous.