Clascoterone Male Pattern Hair Loss Treatment in Development
Androgenetic alopecia (AGA), perhaps better known as Male Pattern Baldness, is the most common form of hair loss worldwide. Therefore it may be surprising to learn that there are currently only two treatments appropriately licensed or approved by the UK and USA medical regulatory bodies, the MHRA and the FDA.
These well-established topical and oral medications have been shown to be effective in stabilising shedding, promoting regrowth and, when used on an on-going basis, preventing baldness.
Now Cassiopea, a small Italian biotech company, is developing a novel clascoterone antiandrogen treatment which goes by the brand name of Breezula in the hopes of adding to this roster.
The double-blind Phase 2 clinical currently taking place across six different sites in Germany, aims to establish the efficacy and safety of clascoterone, using a placebo vehicle for comparison. Though 404 participants, aged 18-55 years with mild to moderate Male Pattern Baldness, were initially enrolled, there are now 375 subjects with available data suggesting some volunteers may have dropped out.
Results from the half-way, six month point in the trial were announced via press release by Cassiopea on 16th July 2018. They showed clascoterone to have similar results to the clinically-proven drug finasteride 1mg in terms of efficacy.
Finasteride 1mg is a DHT-blocker, inhibiting this hormone which is known to cause thinning hair and hair loss by attaching to hair follicles along the top of the scalp, from crown to vertex, in men with a genetic predisposition to Male Pattern Baldness. It comes in an oral, one-a-day 1mg tablet form which has been clinically-proven. A topical finasteride solution - whilst not yet approved by the necessary medical regulatory bodies - is currently being developed.
Breezula has a similar effect in that it is designed to inhibit DHT through clascoterone being absorbed from where the lotion is applied on the scalp, into the hair follicles and bloodstream, rather than the current system option. Systemic medication, including finasteride 1mg, involves a prescription drug entering the body via the bloodstream and then being circulated to the relevant areas, such as the hair follicles.
The developers say that Breezula also 'reduces the skin’s production of prostaglandin D2, a hormone-like compound that, in elevated levels, can inhibit hair growth'.
Various doses are being tested, with a 7.5 per cent solution applied twice daily to the scalp currently producing the most positive results with a 62 per cent improvement in hair growth across the trial participants. Interestingly, the men being studied are noted as having genetic hairloss that affects their vertex - top of the scalp - or their temporal regions. This is particularly noteworthy given finasteride has not been proven - as a result of a lack of data - in relation to treating a receding hairline. The range of hair treatments being tested can be seen in the table below. Continues below...
Six Month Interim Analysis Efficacy Results (PP) of Clascoterone (Breezula) topical treatment for Male Pattern Baldness. Information released by Cassiopea, July 2018 [TAHC = Target Area Headcount; HGA = Hair Growth Assessment; BID = twice per day; QD = once per day; Vehicle = Placebo]
Medications that are applied topically tend to have a lower side effect profile than systemic medications. As such, it is no surprise Cassiopea claims that, so far, Breezula has demonstrated minimal side effects.
Those that have occurred have been reported as local skin infections classified as 'mild' and not related to any kind of 'hormonal disturbances'. The company explains this as follows: 'Clascoterone is metabolized quickly to Cortexolone, a physiological component of the body’s endogenous pool of corticosteroids, thus attaining high local activity without having any systemic effects.'
Former president of the North American Hair Research Society and the International Society of Hair Restoration Surgery, Dr. Ken Washenik, commented on the interim findings: “The interim data on Clascoterone represents a dramatic advance in the treatment of AGA that has been on the ”bucket list” of physicians who treat AGA and their patients for decades. The promise of the same, or improved, efficacy, without any systemic androgen-related side effects, from a topical application, compared to a systemic medication, provides important hope for these patients and their physicians.”
Trials for the men's version continue with a view to gaining FDA approval as soon as possible. This is estimated to be around 2022 which isn't great news for those wanting to address this permanent, progressive form of hair loss sooner rather than later.
The encouraging six month results have led to a women's trial getting the green light, however. Breezula will be tested in clinical trials as a potential treatment for Female Pattern Hair Loss though the start date is yet to be announced.
Although high strength minoxidil can be used by both sexes, finasteride is neither recommended nor approved for use by women as a hair loss treatment. Therefore, if a clinically-proven, safe and effective antiandrogen for women were to be developed, this would certainly be considered a significant breakthrough and a welcome addition to current hair loss treatment options.
These well-established topical and oral medications have been shown to be effective in stabilising shedding, promoting regrowth and, when used on an on-going basis, preventing baldness.
Promising trial results so far
The double-blind Phase 2 clinical currently taking place across six different sites in Germany, aims to establish the efficacy and safety of clascoterone, using a placebo vehicle for comparison. Though 404 participants, aged 18-55 years with mild to moderate Male Pattern Baldness, were initially enrolled, there are now 375 subjects with available data suggesting some volunteers may have dropped out.
Results from the half-way, six month point in the trial were announced via press release by Cassiopea on 16th July 2018. They showed clascoterone to have similar results to the clinically-proven drug finasteride 1mg in terms of efficacy.
Finasteride 1mg is a DHT-blocker, inhibiting this hormone which is known to cause thinning hair and hair loss by attaching to hair follicles along the top of the scalp, from crown to vertex, in men with a genetic predisposition to Male Pattern Baldness. It comes in an oral, one-a-day 1mg tablet form which has been clinically-proven. A topical finasteride solution - whilst not yet approved by the necessary medical regulatory bodies - is currently being developed.
Breezula has a similar effect in that it is designed to inhibit DHT through clascoterone being absorbed from where the lotion is applied on the scalp, into the hair follicles and bloodstream, rather than the current system option. Systemic medication, including finasteride 1mg, involves a prescription drug entering the body via the bloodstream and then being circulated to the relevant areas, such as the hair follicles.
The developers say that Breezula also 'reduces the skin’s production of prostaglandin D2, a hormone-like compound that, in elevated levels, can inhibit hair growth'.
Various doses are being tested, with a 7.5 per cent solution applied twice daily to the scalp currently producing the most positive results with a 62 per cent improvement in hair growth across the trial participants. Interestingly, the men being studied are noted as having genetic hairloss that affects their vertex - top of the scalp - or their temporal regions. This is particularly noteworthy given finasteride has not been proven - as a result of a lack of data - in relation to treating a receding hairline. The range of hair treatments being tested can be seen in the table below. Continues below...
Minimising side effects
Medications that are applied topically tend to have a lower side effect profile than systemic medications. As such, it is no surprise Cassiopea claims that, so far, Breezula has demonstrated minimal side effects.
Those that have occurred have been reported as local skin infections classified as 'mild' and not related to any kind of 'hormonal disturbances'. The company explains this as follows: 'Clascoterone is metabolized quickly to Cortexolone, a physiological component of the body’s endogenous pool of corticosteroids, thus attaining high local activity without having any systemic effects.'
Former president of the North American Hair Research Society and the International Society of Hair Restoration Surgery, Dr. Ken Washenik, commented on the interim findings: “The interim data on Clascoterone represents a dramatic advance in the treatment of AGA that has been on the ”bucket list” of physicians who treat AGA and their patients for decades. The promise of the same, or improved, efficacy, without any systemic androgen-related side effects, from a topical application, compared to a systemic medication, provides important hope for these patients and their physicians.”
To be tested for women's hair loss
Trials for the men's version continue with a view to gaining FDA approval as soon as possible. This is estimated to be around 2022 which isn't great news for those wanting to address this permanent, progressive form of hair loss sooner rather than later.
The encouraging six month results have led to a women's trial getting the green light, however. Breezula will be tested in clinical trials as a potential treatment for Female Pattern Hair Loss though the start date is yet to be announced.
Although high strength minoxidil can be used by both sexes, finasteride is neither recommended nor approved for use by women as a hair loss treatment. Therefore, if a clinically-proven, safe and effective antiandrogen for women were to be developed, this would certainly be considered a significant breakthrough and a welcome addition to current hair loss treatment options.
The Belgravia Centre
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