Device May Predict Success of Hair Loss Treatment Response
One of the top queries from people looking into how to regrow thinning hair is "does hair loss treatment work?" Whilst results can never be guaranteed given everyone responds uniquely to medication, certain levels of regrowth and stabilisation can be estimated on a case-by-case basis by experienced professionals, up to a point.
Now, the makers of a new device - currently seeking FDA clearance - claim it can predict how well men and women with androgenetic alopecia will respond to the clinically-proven treatment, minoxidil.
Androgenetic alopecia is perhaps more commonly referred to as Male Pattern Baldness and, in women, Female Pattern Hair Loss, and minoxidil is currently the only unisex MHRA licensed and FDA approved medication for its treatment.
Follea International, Ltd. submitted a De Novo application to the FDA for the prescription medical device, designed to be used by doctors and specialists, in September 2017. Called the 'Minoxidil Response Test' it was developed to help determine how effective the topical drug may be for treating genetic hair loss on an individual basis with a 24 hour turnaround time for results.
'De Novo' is the classification given by the US Food and Drug Administration (FDA) when assessing submissions for new devices which do not fit any existing classes. If a De Novo application is granted, the FDA states that this then 'establishes new “device type” along with classification, regulation, necessary controls and product code". It further notes that the "device is [then] eligible to serve as a predicate for new medical devices, where appropriate". Essentially this means that a new classification may be created and similar devices that are developed in the future may be classed in the same manner.
As this device is still awaiting the FDA's response, and clinical trial data is currently unavailable, there is no way to determine how well it may work. The Minxoidil Response Test is currently not cleared or approved by the MHRA or the FDA and its trial information is not stated on its website.
Minoxidil is a firmly-established topical vasodilating drug applied directly to the scalp where needed, either once or twice per day as directed. It is known to promote accelerated hair growth in both men and women with pattern hair loss, though the precise reason remains unconfirmed. It is understood to be due to the solution opening potassium channels, increasing localised blood flow to the areas around where it is applied.
According to the makers of this new test, "While the safety of topical minoxidil has been established, the efficacy remains relatively low i.e., only 30-40% of patients respond following 4-6 months of daily treatment." This assessment of the number of patients seeing results seems incredibly low and, in the experience of Belgravia's hair loss experts, the actual figure is likely to be far higher.
"We do not know what criteria this figure is based upon and that is crucial in order to understand the basis on which it is provided," says Belgravia superintendent pharmacist and senior hair loss specialist, Christina Chikaher. "Little information or clarity has been given as to their statements and these do require substantiation in order to form a proper context."
"For example, there are many versions of minoxidil available and the drug is known to be dose-dependent. The vagueness of their statement gives no consideration as to which doses it refers to, the age or medical profiles of those using the medication, or - a critical factor - their level of hair loss. For instance, if a male with a receding hairline that is so advanced that the skin has become smooth and shiny either side of his widow's peak, minoxidil is almost certain not to work in these areas because it cannot work on bald areas. Active hair follicles capable of hair growth are required in order for any formulation of topical minoxidil to have a chance of being effective."
"As minoxidil can be bought in certain solutions over the counter and without needing a prescription or medical advice, anyone can purchase it without necessarily knowing if it is the right product for them," she adds. "This is why at an established hair loss clinic a thorough assessment is carried out by a specialist before a personalised treatment course tailored to the client's individual level and pattern of shedding, as well as their medical suitabilities, is recommended. This is the approach we take at Belgravia and it is a realistic - and successful - one, designed to give the client the best idea of what is involved and what to expect before they start so that they can make an informed decision."
It is worth noting that the American biotech company behind the new device is currently also developing an 'Anti-Hair Shedding Treatment'. This claims to be a strengthening product focused on reducing hair loss in women which - though clever wording makes it unclear - does not seem to address actual hair loss conditions.
Many products claim to 'strengthen' or 'add volume' to thinning hair, however, these tend to be cosmetic so the effect is illusory and temporary. These tend to be designed to improve the look of the hair or the hair's condition on a relatively superficial level. Examples include the way a volumising spray may temporarily make hair appear fuller, or how an intensive conditioning masque may make the hair appear shinier.
What these types of products do not do is treat medical hair loss conditions. There are only two hair loss treatment products currently available that are clinically-proven and officially recognised by the relevant medical regulatory bodies to this: finasteride 1mg (men only) and minoxidil.
Other types of 'hair loss products' which can confuse people are hair vitamins and food supplements. Again, these are not intended to treat any medical issue - including hair loss - nor replace a balanced diet, but they can often help to support a pharmaceutical treatment programme. Classed as an 'adjunct therapy' or hair growth supporting product, food supplements can be used to top-up on key vitamins and minerals that are beneficial to hair health if people are worried that they are not covering all their bases here. Belgravia offers two separate formulations of its premium hair supplement Hair Vitalics - one for Men and one for Women - which provide a wealth of high quality vitamins, minerals, botanical extracts and amino acids, including biotin, selenium and zinc for the maintenance of normal healthy hair growth.
Now, the makers of a new device - currently seeking FDA clearance - claim it can predict how well men and women with androgenetic alopecia will respond to the clinically-proven treatment, minoxidil.
Androgenetic alopecia is perhaps more commonly referred to as Male Pattern Baldness and, in women, Female Pattern Hair Loss, and minoxidil is currently the only unisex MHRA licensed and FDA approved medication for its treatment.
Predicting potential response to minoxidil
'De Novo' is the classification given by the US Food and Drug Administration (FDA) when assessing submissions for new devices which do not fit any existing classes. If a De Novo application is granted, the FDA states that this then 'establishes new “device type” along with classification, regulation, necessary controls and product code". It further notes that the "device is [then] eligible to serve as a predicate for new medical devices, where appropriate". Essentially this means that a new classification may be created and similar devices that are developed in the future may be classed in the same manner.
As this device is still awaiting the FDA's response, and clinical trial data is currently unavailable, there is no way to determine how well it may work. The Minxoidil Response Test is currently not cleared or approved by the MHRA or the FDA and its trial information is not stated on its website.
Minoxidil hair loss treatment
Minoxidil is a firmly-established topical vasodilating drug applied directly to the scalp where needed, either once or twice per day as directed. It is known to promote accelerated hair growth in both men and women with pattern hair loss, though the precise reason remains unconfirmed. It is understood to be due to the solution opening potassium channels, increasing localised blood flow to the areas around where it is applied.
According to the makers of this new test, "While the safety of topical minoxidil has been established, the efficacy remains relatively low i.e., only 30-40% of patients respond following 4-6 months of daily treatment." This assessment of the number of patients seeing results seems incredibly low and, in the experience of Belgravia's hair loss experts, the actual figure is likely to be far higher.
"We do not know what criteria this figure is based upon and that is crucial in order to understand the basis on which it is provided," says Belgravia superintendent pharmacist and senior hair loss specialist, Christina Chikaher. "Little information or clarity has been given as to their statements and these do require substantiation in order to form a proper context."
"For example, there are many versions of minoxidil available and the drug is known to be dose-dependent. The vagueness of their statement gives no consideration as to which doses it refers to, the age or medical profiles of those using the medication, or - a critical factor - their level of hair loss. For instance, if a male with a receding hairline that is so advanced that the skin has become smooth and shiny either side of his widow's peak, minoxidil is almost certain not to work in these areas because it cannot work on bald areas. Active hair follicles capable of hair growth are required in order for any formulation of topical minoxidil to have a chance of being effective."
"As minoxidil can be bought in certain solutions over the counter and without needing a prescription or medical advice, anyone can purchase it without necessarily knowing if it is the right product for them," she adds. "This is why at an established hair loss clinic a thorough assessment is carried out by a specialist before a personalised treatment course tailored to the client's individual level and pattern of shedding, as well as their medical suitabilities, is recommended. This is the approach we take at Belgravia and it is a realistic - and successful - one, designed to give the client the best idea of what is involved and what to expect before they start so that they can make an informed decision."
Company developing hair loss product
It is worth noting that the American biotech company behind the new device is currently also developing an 'Anti-Hair Shedding Treatment'. This claims to be a strengthening product focused on reducing hair loss in women which - though clever wording makes it unclear - does not seem to address actual hair loss conditions.
What these types of products do not do is treat medical hair loss conditions. There are only two hair loss treatment products currently available that are clinically-proven and officially recognised by the relevant medical regulatory bodies to this: finasteride 1mg (men only) and minoxidil.
Other types of 'hair loss products' which can confuse people are hair vitamins and food supplements. Again, these are not intended to treat any medical issue - including hair loss - nor replace a balanced diet, but they can often help to support a pharmaceutical treatment programme. Classed as an 'adjunct therapy' or hair growth supporting product, food supplements can be used to top-up on key vitamins and minerals that are beneficial to hair health if people are worried that they are not covering all their bases here. Belgravia offers two separate formulations of its premium hair supplement Hair Vitalics - one for Men and one for Women - which provide a wealth of high quality vitamins, minerals, botanical extracts and amino acids, including biotin, selenium and zinc for the maintenance of normal healthy hair growth.
The Belgravia Centre
The Belgravia Centre is a world-renowned group of a hair loss clinic 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 from anywhere in the world for home-use treatment.
View our Hair Loss Success Stories, which includes the world's largest gallery of hair growth photos and demonstrates the level of success that so many of Belgravia's patients achieve.
