Follica Male Pattern Hair Loss Treatment Completes Phase 2 Trial

In June 2019 we reported on a new device developed by USA-based biopharmaceutical company Follica, Inc, to treat Male Pattern Baldness.

At this stage it was recruiting men for Phase II clinical trials of its "in-office" Hair Follicle Neogenesis (HFN) device, used alongside topical medication, designed to promote hair growth through hair follicle regeneration.

On 19th December 2019 Follica, Inc circulated a press release announcing its completion and topline safety and efficacy data from the small-scale trial which the company describes as "compelling".

"The compelling data generated by the company thus far indicate that Follica’s approach could be a promising new option for the approximately 90 million people who are eligible for the treatment of androgenetic alopecia in the United States alone,” said Dr Ken Washenik, MD, PhD. senior medical advisor to Follica.

Skin wounding to encourage hair regrowth

The HFN device that was trialled applies micro-abrasions to the scalp. This involves lightly wounding the scalp so that the ensuing healing process - combined with the effects of an unspecified "topical on-market drug", believed to be the hair loss medication high strength minoxidil - then further promotes active hair growth.

Unlike established hair growth supporting products which have been FDA-cleared for the purpose of treating androgenetic alopecia, for instance the HairMax LaserBand devices, the HFN gadget is not meant for home-use; it is designed to be administered at the office of a doctor or dermatologist, or at a designated hairloss clinic.

As its trial information states: "Follica’s approach is based on generating an “embryonic window” in adults via a series of skin disruptions, stimulating stem cells and causing new hair follicles to grow. This process of hair follicle neogenesis involves minimal daily interruption and is enhanced through the application of a topical compound as part of the treatment regimen following HFN."

For its Phase II endpoint-blinded, randomised and controlled trial, Follica recruited 48 men, all aged between 18 and 40 years old, with "moderate" Male Pattern Hair Loss. Their level of shedding had a classification of Hamilton Norwood III-IV.

Participants were then separated into three treatment groups although the treatments each of these arms underwent was not made public. What was published was the fact that researchers conducted the trials to "select the optimal treatment regimen using Follica’s proprietary device in combination with a topical drug", which was successfully achieved.

The optimal frequency and number of treatments was studied across three treatment arms. The regimen was well tolerated across all treatment arms with no reported serious adverse events. No adverse events were related to device treatment. A single non-severe event (headache) was determined to be related to use of the drug and is in line with minor side effects seen from treatment with the approved drug alone.

The findings note that:

• "The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19)."
• "Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire study population and a substantially improved outcome seen with the optimal treatment regimen."
  
• "Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005)."

Jason Bhardwaj, Follica CEO, Jason Bhardwhaj said of the findings, “Our data show that clinical results differ significantly based on the approach to disrupting the skin and confirm Follica’s proprietary treatment paradigm is optimized for new hair growth. We look forward to initiating the pivotal trial.”

The initiation of a Phase 3 registration study is expected in the first half of 2020.

Is Follica worth waiting for?

Belgravia hair loss specialists are often asked by both men and women with thinning hair whether it is worth waiting for new hair loss solutions to become available so they can use the latest treatments to regrow hair and prevent baldness.

The advice is generally the same: genetic hair loss is a progressive condition, meaning it will get gradually worse over time if nature is left to run its course.

For those who are going bald, there is a window of time - whilst the affected hair follicles are still capable of producing hair - during which it may be possible to promote accelerated hair growth and prevent baldness with appropriate treatment. However, once the effects of DHT have rendered the follicles incapable of hair growth, and the skin has taken on a smooth, shiny appearance, non-surgical treatment is no longer likely to be effective.

Therefore, given there are clinically-proven, MHRA-licensed and FDA-approved hair loss treatments available now, it is often advised that those interested in stabilising their shedding get started as soon as possible, using the best options that are currently available. This can be either topical applications of high strength minoxidil, the oral DHT-blocking tablet finasteride 1mg, or both, either of which can be combined with the use of drug-free hair growth supporting products.

New hair loss treatments and devices, as with any other medical therapies and new drugs, take a long time - often many years - to develop, and pass the necessary medical regulatory board requirements to be made available to the public, either over-the-counter or by prescription only. For example, obtaining a license from the UK's MHRA, FDA approval for medicines and FDA clearance for medical devices, in the USA.

As the nature of genetic hair loss is both permanent and progressive, treatment is generally seen as being best to start 'sooner rather than later'.

This does not mean that better hair loss treatments may be developed in future, it simply means they are unlikely to become available quickly enough to be worth anyone losing their hair now, waiting for.

Should a better innovation become available, with all the necessary safety and efficacy licenses, approvals and authorisations required, you can always talk to your hair loss specialist or other treatment supervisor about making the switch. But at least you will not have lost time - and potentially hair - waiting.