The results of some recent testing have just been announced. The results tease the possibility of the first new FDA approved hair loss treatment in decades. That might be exciting enough for many, especially women who cannot use one of the two existing approved treatments. But the real excitement is around the efficacy demonstrated in their results. We look closer.
Follica and The University of Pennsylvania
Follica is a Boston based biotech. Part of the much larger Pure Tech Health group, which boasts within its stable of companies, one FDA approved product along with another 14 at the clinical stage. This week they announced some outstanding test results with puts a new FDA approved hair loss treatment on horizon.
Follica themselves have signed a global marketing deal with the University of Pennsylvania. It allows them to develop and market a breakthrough in hair loss science discovered in one of the University laboratories. That research centred around using an established technique and testing its effect on hair loss. The technique itself requires the skin to be intentionally disrupted or damaged. This disruption sees the body send healing cells to the site of the damage. On arrival at the site of the damage, those cells need to make a decision on exactly what type of cell they should become. It is this ‘decision making’ process that the team at Pennsylvania was investigating. The hope was that they might influence the outcome of that decision. For their work on hair follicles, they were hoping to encourage the cells to choose to become hair cells rather than skin cells.
Their work and results were sufficient to convince Follica to take on the research and go through to clinical trials. With the aim, ultimately, of coming to market with a product. With the support of solid trial results, it could mean the introduction of only the third FDA approved hair loss treatment and the first for decades.
FDA Approved Hair Loss Treatments
Of the two existing hair loss treatments that have FDA approval only one is considered safe for women. This is due to side-effects that could potentially damage an unborn baby. Both existing treatments come with side-effects that make a decision to use them challenging for some. Both treatments require a lifetime commitment so the threat of a lost libido, for example, is too much for many young men.
When we factor in the efficacy rates on the existing treatments the decision does not get any easier. Bear in mind that anyone embarking on a course of treatment might need to wait 6 months to see any improvement. That glacial rate of improvement might not happen at all, a significant minority will not experience any. Testing has set the benchmark for improvement at around 12% to be deemed worthy of approval. It may not sound like much, and to be honest, it isn’t, but it does mean the progress of hair loss has been halted and to some degree reversed. A miracle that has taken humanity thousands of years to achieve.
Hair Loss – A New Hope
So just in time for Christmas, Follica has finally announced details of their testing on the new treatment. Their trial involved 48 subjects, all with hair loss at Grade 3 or 4 on the Norwood Scale, with some taking differing levels of the medication and others taking a placebo. The skin was damaged during a 5-minute session using a device the Follica team has developed for the task. They then treat the area with a soup of growth factors.
Measuring the success was done using the accepted method of counting new non-vellus hairs. As previously mentioned, for the existing treatments that benchmark is set at 12%. Even the least effective dosage using the Follica method was found to produce a 29% improvement. The most effective dosage actually achieved an incredible 44%. This is not just an improvement, this is the difference between a treatment that barely does what it claims, and one that delivers visible improvement to the naked eye. It seems to us almost certain that a new FDA approved hair loss treatment is on horizon.
The Hair Ambulance
To be clear. These results signalled the end of a highly successful Phase II clinical trial in which all endpoints were reached. We can look forward to large scale Phase III clinical trials in 2020 and will be waiting, with bated breath, for more news. This really could be a game-changer for the hair loss market, one that finally consigns the underwhelming offers currently available to the history books.
The Hair Ambulance brings world-leading hair loss solutions to your door. Hair loss is no longer inevitable. Use the contact form here to either arrange a home visit or book a consultation at one of our private hair loss clinics. Early intervention is a necessity. Do not delay if you are concerned about your hair loss.