For around 1.5 million men in Australia and 35 million men in the US, baldness is a significant issue.
Around 45 per cent of Australian men will develop significant hair loss – according to a 2003 Victoria-based study with a sample size of 5000 by Sinclair Dermatology.
"Hair loss is pretty much universal in men as they grow older," says.
"However for some men, particularly if hair loss is severe or it happens at a young age it can actually become a significant problem. Men with premature hair loss look older, find it more difficult to find a partner, and have even been shown to be discriminated against in the workplace."
The problem with the current hair loss treatments available?
They have "limited effectiveness and unwanted side effects," claims Sinclair.
The first option, Minoxidil lotion or Regaine (previously Rogaine), requires twice-daily application to the scalp. "If you use it continuously and properly...over many, many months you can get about nine percent of your hair to regrow.
"But it often irritates the scalp, it's messy and alters the smell and feel of the hair." Six-weeks is the average length of use "because people don't like how it looks or feels," yet regrowth will only start about four months into treatment.
Finasteride is the second hair loss treatment option approved by the Therapeutic Goods Administration (TGA), and unlike Regaine which can be used by women, is for men only. "The main rule with Finasteride is that you put a handbrake on the hair loss process, and stop it from getting worse," Sinclair said. "Finasteride might generate a bit of regrowth on vertex of scalp - the bald spot at the back - but it won't regrow hair at the front of the scalp."
Taken in tablet-form once-daily, Sinclair said Finasteride is usually well-tolerated. However around two per cent of men will experience side effects of erectile dysfunction or reduced libido, "which should reverse if treatment stops."
Treatment in the future
The Samson Clinical Trials conducted at the Sinclair Dermatology Research Clinical Trials Centre over the last 10 years are generating promising results in the hair loss treatment-field. "We have been developing Minoxidil as a tablet. The patent has been awarded in Australia and is currently under examination in the US and Europe.
"The benefit of the tablet is that you can deliver much higher concentrations of Minoxidil to the hair follicle and stimulate proportionately greater hair growth. We're seeing double or triple the amount of hair growth with the tablet than you seen in the lotion (Regaine). Unlike Finasteride, Minoxidil regrows hair over the entire scalp and so the tablets are also helping to restore receding hairlines," Sinclair said.
"The next step is to do further dose ranging studies to determine the ideal dose to take to market. As the treatment will need to be administered long-term to maintain the regrowth, safety is paramount."
Beyond the trials
While high doses of Minoxidil can cause side effects including hypotension (low blood pressure), fluid retention and tachycardia (a resting heart rate that is above normal), these side effects are dose-related, Sinclair said.
"In the trial-doses administered, once-daily Minoxidil tablets had minimal side effects.
"We hope to commence [the final trial stage,] Phase III clinical trials in 2019, which will require significant additional investment. However the global hair loss market is estimated to be worth $4 billion per year, and so we are optimistic we will be able to find commercial partners to help take it to the next stage."
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