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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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Belgravia Centre Hair Loss Treatment Before and After Results - New Success Story

A new entry has just been added to Belgravia’s Male Hair Loss Treatment Success Stories gallery.

Find out what this client had to say and see his regrowth results close up, or find out more about treating Male Pattern Baldness by clicking the buttons below…

(Results may vary and are not guaranteed)

VIEW SUCCESS STORY

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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.

HairlossANSWERS - Click to Submit Your Query to Our Hair Loss Experts

Name: Christian

Question: I started using fin and minox from the chemist three months ago and now I have acne. Is it from the treatments and will it go away or do I have to stop using them?

Answer: Hi, Christian. Firstly, as you are not a Belgravia client we would recommend checking directly with your medication provider. This is because they should know more about the precise products you are using and your medical profile.

skin condition acne

Our general advice, however, is that acne is not a listed side effect for either finasteride 1mg or topical minoxidil. You can check the listed known adverse events on the patient information leaflets which should come with your medications, or can be provided by the pharmacist you purchased them from.

People do respond differently to treatments though, so, if you think your hair loss products may be causing acne, it may be a good idea to stop the treatment for a while and see if your skin condition improves.

If the acne gets better, you may restart your treatments one at a time and note if the acne returns.

Should stopping hair loss treatment have no effect on your acne, there is most likely another cause behind it and you should contact your GP.

Tell them of any medications – oral or topical – and food supplements you are using during your appointment so that they can make a full assessment.

There are many potential causes of acne, including genetics, and your GP should be able to help you establish the reason behind your skin condition, and advise you on how best to clear these spots up.

We have assumed that the acne you refer to is on your face and/or body; if it is on your scalp, we recommend seeing a hair specialist for a consultation in addition to taking the above steps.


Circ - Belgravia Centre Hair Loss Clinics LondonThe 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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Belgravia Centre Hair Loss Treatment Before and After Results - New Success Story

A new entry has just been added to Belgravia’s Male Hair Loss Treatment Success Stories gallery.

Find out what this client had to say and see his regrowth results close up, or find out more about treating Male Pattern Baldness by clicking the buttons below…

(Results may vary and are not guaranteed)

VIEW SUCCESS STORY

Treatment information


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.

A 2017 Phase 2a clinical trial exploring twice-per-day oral doses of setipiprant as a potential treatment for Male Pattern Hair Loss has now published its findings.

Setipiprant is an investigational drug – originally developed as an allergy medication – currently being explored as an antagonist for the PGD2 receptor; the PGD2 receptor is an enzyme that was shown in 2012 to affect hair growth and be an area worthy of study in order for targeted treatments for various hair loss conditions to be developed.

The randomised, multi-centre study was sponsored by Allergan, and pitted setipiprant against finasteride 1mg – currently the only MHRA-licensed and FDA-approved oral men’s hair loss treatment for androgenetic alopecia.

chemical structure of setipiprant

In the results, published on 9th April 2019, some of the data for the finasteride element of the trial has been omitted, however.

Three-arm trial

The double-blind American trial comprised 169 men aged between 18 and 49 years of age, all with a confirmed diagnosis of genetic hair loss.

These participants formed three separate groups, each of which was administered oral tablets for 24 weeks.

One group of 83 men was given setipiprant 1,000mg (2 x 500mg) to be taken at 12 hour intervals, another group of 12 men was given finasteride 1mg to be taken once per day, whilst a further 74 men took a placebo twice daily at 12 hour intervals.

There were a number of participants who did not complete the trial – 26 of those taking setipiprant, 26 of those taking the placebo and 4 from the finasteride group. Reasons ranged from withdrawing consent and not properly complying with the study drug, to adverse events.

As such, the numbers reduced to 78 taking setipiprant, 11 taking finasteride and 70 taking the placebo.

For these men, the following terminal hair counts were recorded in the target area being studied, described as being at the “anterior leading edge of vertex thinning area of scalp and centered with a semi-permanent microdot tattoo to ensure same target area was reproduced each visit”.

Potentially insignificant results

Target Area Hair Count Within Left 1cm^2 Circular Area - Setipiprant Allergan study April 2019
Target Area Hair Count Within Left 1cm^2 Circular Area (in cm^2) After 24 Weeks of Treatment

The changes seen after 24 weeks of treatment, of each type, were measured using digital imaging and the recorded data can be seen in the bar chart, here.

On first appearance, these hair count results look impressive for setipiprant, however, it is only when taking into account the mean data that the true picture emerges. And it is certainly less compelling.

Given the mean is so varied – and the statistical analysis also had a P-value of 0.9239) – this effectively renders them insignificant. This is perhaps why the results were published without fanfare or press release – just yet, at least.

We believe that Allergan is currently waiting for its study to be federally evaluated so, this may also be a reason to delay comment.

To be clear, this does not mean that setipiprant does not show promise as a Male Pattern Hair Loss treatment; what it means is that further research – ideally using better matched participants – is needed to properly establish its potential.

“Although the mean number of hair count per square cm was the highest for setipiprant, the standard deviations were also the highest which suggests the particpants in this group had very different results from each other. Also, looking at the other tables they have provided in their results, their p values suggest the results did not have statistical significance,” says Belgravia hair loss specialist, Rali Bozhinova. “Overall, I think they would need more research, ideally with more participants.”

For now, it remains unproven and far more clinical trials are required if Allergan wishes to meet its current pipeline estimate of a 2021/22 release.


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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Belgravia Centre Hair Loss Treatment Before and After Results - New Success Story

A new entry has just been added to Belgravia’s Male Hair Loss Treatment Success Stories gallery.

Find out what this client had to say and see his regrowth results close up, or find out more about treating Male Pattern Baldness by clicking the buttons below…

(Results may vary and are not guaranteed)

VIEW SUCCESS STORY

Treatment information


Circ - Male Pattern Baldness hair loss treatment Belgravia Centre clinic LondonThe 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.

Belgravia Centre Hair Loss Treatment Before and After Results - New Success Story

A new entry has just been added to Belgravia’s Male Hair Loss Treatment Success Stories gallery.

Find out what this client had to say and see his regrowth results close up, or find out more about treating Male Pattern Baldness by clicking the buttons below…

(Results may vary and are not guaranteed)

VIEW SUCCESS STORY

Treatment information


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.

HairlossANSWERS - Click to Submit Your Query to Our Hair Loss Experts

Name: Scott

Question: I heard that if your hair loss isn’t too bad you can take finasteride three times a day instead of every day – is this true?

Answer: Hi, Scott. This is incorrect. Finasteride 1mg is taken once per day in all cases where it is prescribed as a treatment for Male Pattern Baldness, regardless of the level of thinning.

finasteride DHT blocker 1mg mens hair loss treatment tablet

The reason for this is to keep the optimum amount of the active medication in your system in order to effectively inhibit dihydrotestosterone (DHT). DHT, being the testosterone by-product which latches on to hair follicles located around the top of the scalp and hairline, in men genetically-predisposed to genetic hair loss.

This gradually weakens these sensitive follicles, causing a drop in hair density and producing increasingly finer, thinning hair and/or a receding hairline. If left unchecked, this can lead to eventual baldness.

Finasteride, taken in the authorised 1mg per day doses – as licensed by the UK’s medical regulatory board, the MHRA, and approved by its American counterpart, the FDA – ensures a worthwhile amount stays in your system to continually counteract DHT.

Studies have shown the half-life of oral finasteride 1mg – the length of time it stays in your bloodstream – to be 4.7 hours to 7.1 hours, with “slow accumulation” occurring when this form of treatment is used over a long period of time. This still does not mean that doses can be skipped, however.

Additionally, it is worth pointing out that overusing any medication can lead to side effects and, in the case of finasteride 1mg, is unlikely to have any hair growth benefits when compared to the authorised dose. Therefore, it is important to only take the 1mg per day dose that is recommended.

Using hair loss treatment erratically – including regularly missing doses – is unlikely to provide the maximum benefits patients look for when using it for preventing baldness. The same is true of the other clinically-proven hairloss solution, high strength minoxidil.

Before starting a treatment regime, it is wise to consult a hair loss specialist for a number of reasons, even if you eventually decide not to pursue their services. Firstly, doing so will provide you with a professional diagnosis of your condition; although many men assume they are starting to go bald when they notice some shedding or a drop in the volume of their hair, these signs do not necessarily mean they have Male Pattern Baldness.

Secondly, once you have a diagnosis, personalised treatment recommendations – including relevant hair growth supporting products – can be made based upon factors such as your hair loss condition, level and pattern of shedding, medical profile and – a point which should not be overlooked – your lifestyle requirements. After all, there’s no point in spending money on treatments you won’t actually use, so it’s always best to take a practical approach to finding the best hair loss solutions for each individual.


The 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.

Related Stories


Belgravia Centre Hair Loss Treatment Before and After Results - New Success Story

A new entry has just been added to Belgravia’s Male Hair Loss Treatment Success Stories gallery.

Find out what this client had to say and see his regrowth results close up, or find out more about treating Male Pattern Baldness by clicking the buttons below…

(Results may vary and are not guaranteed)

VIEW SUCCESS STORY

Treatment information


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.

The International Society of Hair Restoration Surgeons (ISHRS) has launched a campaign to warn people of the dangers associated with getting a ‘black market’ hair transplant.

In a shocking press statement from March 2019, the industry body advised that 77.5 per cent of its members – qualified hair restoration surgeons – have seen an increase in the number of people coming to them for help after ‘botched’ procedures.

The reason for the number of poor results has been put squarely at the door of illegal hair transplant clinics, and poorly trained – or completely unqualified – non-medical practitioners carrying out these highly skilled procedures.

The ISHRS reports that, due to the demand for hair transplants, often cheap ones carried out abroad, and unscrupulous attempts to cash in on people’s hair loss concerns, they have even heard of instances where the operation has been carried out by a taxi driver.

Disfiguring results, scarring and infections

ISHRS members reported cases where post-op patients of these dubious ‘clinics’, presented to them with scarring and infections, over-harvesting – where too much donor hair has been removed, leaving the area bald with little hope of there being enough to use for any corrective procedures – and infections.

Additionally, poor results such as “disfiguring” unnatural looking hairlines and follicles being placed so that grafted hair grows in the wrong direction, were obvious.

Another issue the medical association feels potential customers, particularly those seeking a hair transplant abroad and looking into medical tourism, should be aware of is inaccurate graft counts.

The cost of hair transplants tends to be worked out based on the number of grafts, which is essentially a per-hair price. The ISHRS advised that patients have been booked in – and charged for – a specific number of grafts, but in reality have received around half that amount.

When having medical procedures in a foreign country, whilst their marketing may be sophisticated, including online reviews which cannot be easily verified by the viewer, the reality can often include poor-to-no aftercare and language barriers, making it hard to address any concerns or pursue recourse.

This is, of course, in addition to any issues with the conditions of the clinic and its equipment, not to mention ensuring the staff carrying out your operation are properly, medically trained and have the relevant skills and qualifications.

One way to avoid falling into the black market hair transplant trap is to check the ISHRS website – ishrs.org – to verify credentials for a specific clinic and/or surgeon, before going ahead.

“This is a serious crisis for anyone seeking help for hair loss, which is why the ISHRS is working diligently to educate patients about these dangers. We have many competent doctors in the ISHRS operating in the medical tourism industry who have signed a commitment that the Doctor does the surgery and have attended educational meetings regularly to assure the hair restoration surgery in the end makes you happy and not one you will regret for a lifetime,” says Ricardo Mejia, MD, chair of the ISHRS Committee on Issues Pertaining to the Unlicensed Practice of Medicine.

Non-surgical alternatives

Unethical hair restoration practitioners are unlikely to provide unbiased advice when it comes to dealing with hairloss.

It is likely a hair transplant is neither necessary nor appropriate for certain levels of Male Pattern Baldness, or for men who are under 30 years old.

Where there is a drop in hair density and thinning hair or a receding hairline but the hair is still present – the scalp has not yet taken on the smooth, shiny look associated with going bald – non-surgical hair loss treatment is generally the first step to consider.

Many top surgeons advise men considering hair replacement surgery to first follow a course of clinically-proven hair treatments – high strength minoxidil and/or finasteride 1mg – for a minimum of 6 to 12 months.

Doing so will give the candidate an idea of what can be achieved without surgery but, should they still decide to go ahead with the op, they will have maximised their hair growth and stabilised hair fall in preparation for the procedure. This is likely to lead to better results as it gives the surgeon more to work with, as well as a cleaner area with less shedding to deal with.

For those who have a hair transplant, aftercare is critical in maintaining the results obtained, which should become fully realised around 12 months post-op. Continuing to follow this type of pharmaceutical hair loss treatment programme, with additional hair growth supporting products where desired, plays a big role in preventing baldness around the grafts.

When choosing a surgical practitioner or hair loss specialist, it is vital to not only do your research, but to meet with a number of different businesses in order to make an informed decision.

Dealing with hairloss can be a tough and emotional ordeal so, once you know they are properly qualified and equipped to meet your needs, go with the professionals you feel most comfortable dealing with and will be comfortable about reaching out to for help, should you need it.


The 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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