Update on Hair Restoration Future

Restoring the hair lost due to hereditary factors is the dream of many men and women suffering from hair loss. Until not too long ago, the only effective and authentic-looking options for reversing hair loss were non-surgical cover-ups such as different hair systems, hair pieces, wigs, hairweaves and toupees. It was only with the arrival of follicular unit transplantation and the discovery of the true cause of baldness - the harmful effects of dihydrotestosterone (DHT) on our hair follicles - that the hair-loss sufferer’s chances of reversing their condition naturally have greatly improved.

The three best weapons in the fight against hair loss available today are the two FDA-approved medicinal drugs – finasteride (Propecia) and minoxidil (Rogaine/Regaine) and hair surgery, the follicular unit transplantation and, especially, the follicular unit extraction technique. These drugs and surgical techniques are also acknowledged by the health authorities such as FDA as the only legitimately proven tolls to treat hair loss. However, no ultimate cure exists yet as each of the three aforementioned hair restoration methods has its limitations. It is quite common to combine all three tools to achieve better results but even then it is not possible to help every patient to stop their hair loss and reverse the losses. Minoxidil and finasteride work well only in the vertex area of the scalp and are suitable mainly to halt hair loss rather than to regrow hair while finasteride cannot be used by women at all. Hair transplantation is suitable only for people who have sufficient hair density in the donor area, and many women, who typically suffer from diffuse thinning, do not make good candidates for hair transplant surgery.

Therefore, hair scientists around the world are relentlessly searching for new approaches to treating baldness. There are presently several promising drugs and new techniques under development listed below but progress seems to have slowed down recently due to the global financial crisis, as some R&D projects are finding it increasingly difficult to raise financing to further their research. None of the currently undergoing clinical studies is in the phase 3 which is the final and by far the most expensive stage of any pharmaceutical research.

The biggest progress has been achieved on dutasteride. Dutasteride is an antiandrogen drug, in its chemical structure and mode of action it is similar to finasteride. It is currently only approved by the FDA for the treatment of benign prostatic hyperplasia (non-malignant prostate enlargement) and since it is a dual 5-alpha reductase inhibitor, it should be a more potent DHT blocker than finasteride. Therefore, it is believed to be more effective in treating hair loss, especially in the frontal area of the scalp and preliminary clinical data confirmed this assumption. Dutasteride already completed Phase III clinical testing a few years ago but the study results were not published yet and its originator has not yet submitted request for it approval to the FDA. It is not exactly known what is holding it back as it seems that initial worries over dutasteride's severe side-effects were not confirmed by the clinical data.

NEOSH101 was originally developed by the US medical research company Neosil and was until recently undergoing phase IIb clinical testing. At the end of 2008, Neosil was acquired by Peplin, Inc., a development stage specialty pharmaceuticals firm and in September 2009 Peplin was taken over by the Danish LEO Pharma and since then no information on the further progress of the clinical trials has been released. In previous clinical trials, NEOSH101 was shown to be a more powerful and faster-acting, hair growth stimulant than minoxidil and it only needs applying once daily. Though significantly improving the current hair-loss treatment options, NEOSH101 is not going to become the ultimate cure for baldness. The last news we have heard about this study is from 2008 when Peplin Inc. was yet recruiting new candidates for Phase II. clinical study. No news regarding this project has ever been released by the current owner LEO Pharma. It seems that the study was temporarily suspended, most likely for financial reasons.

Another promising development area is the telomerase research. Telomerase is an enzyme that is able to put natural caps on telomeres and thus protect them from shortening. Telomerase thereby maintains the genomic integrity. Shortened telomeres are associated with causing premature aging processes. However, the uncontrolled activation of telomerase can trigger cancer. Cancer research is the main focus of the telomerase studies but scientists are also looking for other applications, such as anti-aging drugs and drugs against baldness and grey hair. Telomerase research could really change the world of medicine but the progress is slow and the first commercial application might be a good 15 years away.

Hair multiplication, often called hair cloning, follicular neogenesis or hair regeneration, is the next hopeful treatment option being explored. This technique involves extracting hair follicles from the back of the patient's scalp (some techniques only pluck the hair and use tissue surrounding the hair roots), culturing and multiplying their dermal papilla cells and injecting the newly-grown hair cells into the bald scalp. The main benefit of hair multiplication would be solving the shortage of donor hair, which is the main limiting factor in hair transplantation. Only a few years back the UK healthcare firm Intercytex and the US Aderans Research Institute (subsidiary of Bosley) were two competitors in hair multiplication research. They both have got in phase II of clinical testing. However, Intercytex had to discontinue this research project due to serious financial difficulties and following its failure to find an investor. Aderans, the main competitor of Intercytex, has acquired the assets of this project but as was mentioned above it is still only in the Phase II of clinical testing of cell-based hair regeneration. It is unlikely that this technique would be ready for the market earlier than in 5 years from now.

Generating new hair follicles in hair-free skin wounds is a totally new approach to regrowing lost hair. It was discovered accidentally when wounded skin in mice started producing new hair while healing. This technology is presently being developed by the US medical device company, Follica, which has licensed this technology from the University of Pennsylvania. Though this method may sound weird, it is said to only use common instruments and drugs that have already been medically approved and thus it might not take much too long for it to become available to the public. Follica recently secured a patent for the methods, kits, tools and instruments used for generating new hair follicles and growing hair.

This list of the undergoing projects in the area of hair-loss research includes the most promising lines of development but it is not exhaustive. However, none of the new therapies, with the exception of dutasteride's application for treating hair loss in men (which is already being prescribed off-label to patients who do not respond well to Propecia), is expected to hit the market before 2018 and the immediate future of hair restoration lies in improving the surgical techniques, increasing the yields of the follicular unit extraction method and making it more affordable to a larger portion of the population.