Topical Finasteride Male Hair Loss Treatment Eyes 2020 Release
It can feel like every day a new, too-good-to-be-true hair loss cure is touted in the media, including everything from McDonald's french fries to drugs designed to treat brittle bones.
However, it does now appear that the first new addition to the arsenal of existing hair loss treatments available to treat Androgenetic Alopecia in men may be on the horizon.
Swiss pharmaceutical company Polichem has been trialling a topical version of the existing male hairloss drug finasteride, known as P-3074 for a number of years. It contains 0.25 per cent finasteride versus the 1mg found in the currently prescribed tablet form, and these studies have involved 459 men, all aged between 18 and 40, being monitored across 46 different locations in Belgium, Germany, Hungary, Russia and Spain.
Polichem's phase III clinical trial completed in March 2018 according to the trial registration listing, yet the company's website still maintains the product is in the Pivotal Phase III stage in the EU. The latest results have not yet been published though those from earlier testing, published in 2016, were promising. They showed the solution to be as effective as the 1mg tablets when applied daily in 100 or 200 µL doses.
Whilst not overly ground-breaking, given it simply involves a novel delivery method of a weaker solution of an existing drug already clinically-proven to treat Male Pattern Baldness, topical finasteride is eagerly anticipated by many. The company is said to be eyeing a 2020 release but this is yet to be confirmed.
Finasteride 1mg is the name of the generic oral drug used to treat Male Pattern Baldness by inhibiting the testosterone-derivative dihydrotestosterone (DHT) in medically-suitable over 18s. It is this hormone, which is crucial for the formation of sexual characteristics during puberty but is largely redundant after this time, that causes the trademark receding and thinning hair associated with hereditary hairloss in both men and women.
DHT does so by binding to genetically-susceptible hair follicles located around the top of the scalp, from hairline to crown, and gradually weakening them until they are incapable of producing hair. This is what gives the outward appearance of increasingly thinner hair and eventual baldness.
It was first discovered that finasteride may have potential hair growth enabling properties in 1992. Users of the drug Proscar, a daily tablet taken by men aged 60+ for the prevention of Benign Prostate Hyperplasia and which contains 5mg finasteride, noticed improvements in their hair. This was investigated and the smaller daily dose of 1mg was found to be optimal for treating Male Pattern Hair Loss.
In 1997, under its first brand name Propecia the 1mg version was licensed by the MHRA and given FDA approval for this use, and the prescription-only drug was released. Propecia's exclusive patent expired in November 2013, allowing other drug companies to offer finasteride as a generic or otherwise branded medication - still all in the 1mg once-per-day tablet form.
The benefits of applying a finasteride solution directly to the scalp, as opposed to taking it orally, are unconfirmed given the trial findings have not yet been released. However, generally, applying a drug topically will minimise potential side-effects. Although the incident rate is relatively low, the possibility of side-effects from finasteride is certainly an area of concern for some men. Presently, men wanting a solution for regrowing hair and preventing baldness without finasteride are often directed to minoxidil-only treatment courses, bolstered by additional hair growth supporting products.
What is particularly interesting about this latest Polichem trial is the pattern of hair loss the drug was tested on. Each of the 459 participants had mild to moderate vertex thinning - thinning hair along the top of the scalp - measuring III vertex, IV or V on the Norwood Hamilton scale. As such, the effects of topical finasteride on a receding hairline - traditionally the most stubborn area, with temporal hair loss taking the longest to regrow - appear to be unproven. Its oral form, in the approved 1mg/day dose, is only proven to be effective for vertex hair loss including the crown area.
When treating male hair loss in any of the key patterns - especially those involving stubborn areas such as a receding hairline or thinning crown - it can be beneficial to also apply appropriate solutions of high strength minoxidil.
This two-pronged attack provides a proactive way to both deter DHT - blocking the cause of further hair thinning - and actively promote hair growth.
In addition to these topical and oral medications, supplementary supporting products can be employed in the form of low level laser therapy devices to stimulate the follicles, and food supplements such as Hair Vitalics for Men to ensure the hair is healthy and properly nourished.
Should topical finasteride succeed in receiving its MHRA license and FDA approval, it could provide an alternative to the current oral treatment.
As superintendent pharmacist and senior hair loss specialist, Christina Chikaher states: "Research papers have been written regarding the promising results of topical finasteride so I certainly look forward to seeing the published findings from this latest trial. It is likely to be quite effective with lessened potential side effects than the oral treatment. If they have completed Phase III testing - assuming the drug has met all necessary criteria regarding safety, efficacy and tolerability - then I would assume they are close to licensing the product so a 2020 release date sounds plausible. It's only 18 months away, after all."
However, it does now appear that the first new addition to the arsenal of existing hair loss treatments available to treat Androgenetic Alopecia in men may be on the horizon.
Polichem's phase III clinical trial completed in March 2018 according to the trial registration listing, yet the company's website still maintains the product is in the Pivotal Phase III stage in the EU. The latest results have not yet been published though those from earlier testing, published in 2016, were promising. They showed the solution to be as effective as the 1mg tablets when applied daily in 100 or 200 µL doses.
Whilst not overly ground-breaking, given it simply involves a novel delivery method of a weaker solution of an existing drug already clinically-proven to treat Male Pattern Baldness, topical finasteride is eagerly anticipated by many. The company is said to be eyeing a 2020 release but this is yet to be confirmed.
What is finasteride?
Finasteride 1mg is the name of the generic oral drug used to treat Male Pattern Baldness by inhibiting the testosterone-derivative dihydrotestosterone (DHT) in medically-suitable over 18s. It is this hormone, which is crucial for the formation of sexual characteristics during puberty but is largely redundant after this time, that causes the trademark receding and thinning hair associated with hereditary hairloss in both men and women.
DHT does so by binding to genetically-susceptible hair follicles located around the top of the scalp, from hairline to crown, and gradually weakening them until they are incapable of producing hair. This is what gives the outward appearance of increasingly thinner hair and eventual baldness.
In 1997, under its first brand name Propecia the 1mg version was licensed by the MHRA and given FDA approval for this use, and the prescription-only drug was released. Propecia's exclusive patent expired in November 2013, allowing other drug companies to offer finasteride as a generic or otherwise branded medication - still all in the 1mg once-per-day tablet form.
The benefits of applying a finasteride solution directly to the scalp, as opposed to taking it orally, are unconfirmed given the trial findings have not yet been released. However, generally, applying a drug topically will minimise potential side-effects. Although the incident rate is relatively low, the possibility of side-effects from finasteride is certainly an area of concern for some men. Presently, men wanting a solution for regrowing hair and preventing baldness without finasteride are often directed to minoxidil-only treatment courses, bolstered by additional hair growth supporting products.
Specific pattern of male hair loss
What is particularly interesting about this latest Polichem trial is the pattern of hair loss the drug was tested on. Each of the 459 participants had mild to moderate vertex thinning - thinning hair along the top of the scalp - measuring III vertex, IV or V on the Norwood Hamilton scale. As such, the effects of topical finasteride on a receding hairline - traditionally the most stubborn area, with temporal hair loss taking the longest to regrow - appear to be unproven. Its oral form, in the approved 1mg/day dose, is only proven to be effective for vertex hair loss including the crown area.
When treating male hair loss in any of the key patterns - especially those involving stubborn areas such as a receding hairline or thinning crown - it can be beneficial to also apply appropriate solutions of high strength minoxidil.
This two-pronged attack provides a proactive way to both deter DHT - blocking the cause of further hair thinning - and actively promote hair growth.
In addition to these topical and oral medications, supplementary supporting products can be employed in the form of low level laser therapy devices to stimulate the follicles, and food supplements such as Hair Vitalics for Men to ensure the hair is healthy and properly nourished.
Should topical finasteride succeed in receiving its MHRA license and FDA approval, it could provide an alternative to the current oral treatment.
As superintendent pharmacist and senior hair loss specialist, Christina Chikaher states: "Research papers have been written regarding the promising results of topical finasteride so I certainly look forward to seeing the published findings from this latest trial. It is likely to be quite effective with lessened potential side effects than the oral treatment. If they have completed Phase III testing - assuming the drug has met all necessary criteria regarding safety, efficacy and tolerability - then I would assume they are close to licensing the product so a 2020 release date sounds plausible. It's only 18 months away, after all."
The Belgravia Centre
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