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Clascoterone Genetic Hair Loss Treatment Trial Update

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A press release from Italian-based Cassiopea, the pharmaceutical company developing a Clascoterone-based genetic hair loss treatment known as Breezula, has provided a “very positive” Phase IIa update.

This stage of the research was intended to establish the efficacy and safety of four separate doses of Breezula, and, according to its manufacturers, the topical anti-androgen has performed well, with no serious side effects related to the treatment being reported.

The press release, dated 16th April 2019, boldly claims the “results indicate that Clascoterone stops the loss of hair and grows new hair”.

What is Clascoterone (Breezula)?

Clascoterone is a newly developed, anti-androgen chemical which is applied topically. In low doses of 1 per cent, it is being explored as a potential acne treatment. However, in larger doses of 2.5 to 7.5 per cent, it is piquing interest as a hair growth product.

As with high strength minoxidil, it is applied directly to the scalp, where it penetrates the skin. It then acts on the androgen receptors located within the sebaceous glands and hair follicles.

Clascoterone Breezula clinical trial results phase 2 male pattern hair loss treatment

Like finasteride 1mg – the oral Male Pattern Hair Loss Treatment for men – Clascoterone is also a DHT blocker. Breezula’s action stops dihydrotestosterone from interacting with specific hair follicles, reducing the likelihood of thinning hair developing.

Increased hair count observed

The 12-month Phase II trial saw 400 men aged between 18 and 55 years old use various doses of Clascoterone. Three groups applied solutions of either 2.5%, 5% or 7.5% Clascoterone twice per day, whilst one group used the 7.5% dose once per day.

A total of 344 participants completed the trial, and the mean data for each group showed an increased hair count during follow-up.

The mean target area hair count increases were as follows: 10.2 for the group using the 2.5% solution, 13.8 for those using 5%, 14.3 for those using 7.5% twice per day and 12.7 for those using the 7.5% solution once per day.

There were also notable mean changes recorded in the target area hair width measurements; these registered as 521.1 for 2.5% users, 615 for 5% users, 762.5 for 7.5% twice per day users and 658.8 for 7.5% once per day users.

Researchers note in regard to the target area hair width data, “highly significant changes vs. vehicle were observed in all active groups with the highest change observed in the 7.5% BID [twice per day] group, which reached borderline statistical significance since the third month (first follow-up visit) and statistical significance at months 6, 9 and 12”.

Furthermore, the results reported an “excellent safety profile”.

Potential benefits for women with PCOS

Commenting on the Breezula clinical trial results, Belgravia hair loss specialist, Rali Bozhinova says, “These results showed statistical significance which of course sounds very promising and I look forward to seeing their future research. It looks like topical Clascoterone is overall well tolerated and is so far showing very positive efficacy on androgen-related conditions such as acne and androgenic alopecia.

Women with PCOS sometimes experience androgenic alopecia, an oily scalp and scalp acne, which are all linked to androgen effects. So, topical Clascoterone may actually be very helpful in such cases.

This study took 12 months but patients with genetic hair loss require ongoing treatment, so I think longer research on the safety of topical Clascoterone will be needed. It will also have to be tested on women.”

Breezula potential release date

In fact, Cassiopea has noted its next steps will be to meet with the FDA in advance of the men’s Phase III clinical trials starting, as well as proceeding with a proof of concept clinical trial in women.

The company’s product pipeline states that it hopes to complete these Phase III trials by 2020, ready for an anticipated launch date of 2022, assuming the MHRA and FDA – and any other appropriate medical regulatory boards – give their authorisations.

For anyone worried about losing their hair now, 2022 – whilst only three years away – is still a long way off. Given Male Pattern Hair Loss is a permanent and progressive condition, those wishing to explore options for stabilising their shedding, promoting hair growth and preventing baldness would be well advised to seek advice now.

Generally, the earlier you can start finding out what works for you, the better the results, when it comes to treating hair loss. There are existing clinically-proven hair loss treatment options which can be paired with additional hair growth supporting products, where appropriate, to form a holistic approach suited to each individual’s medical and lifestyle needs.

Then, if – later down the line – new treatments, such as Breezula, come along and are suitably proven to be safe, tolerable and effective, a specialist will be able to talk you through switching or incorporating it into your current course of hair loss solutions – but at least you’ll have got a head start!


Belgravia Centre Hair Loss Clinic Hair Loss Specialist Free ConsultationThe Belgravia Centre

The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.

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