Evolis: First Clinically-Validated FGF5 Inhibitor Hair Loss Product

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Pharmaceutical company Cellmid Limited has produced a new hair loss product called évolis ONE which has shown promising results in an independently tested, blinded, placebo-controlled clinical study.

The spray-on product is designed to treat genetic hair loss in both men and women with minimal side effects and has various patents pending in connection with its formula.

First clinically-validated FGF5 inhibitor hair growth product

According to reports on the B3C newswire and the évolis website, there have been 'strong positive results in all measured areas of its independently conducted, randomized, blinded and placebo controlled human clinical study of the évolis ONE formulation'.

The product is made in Australia and took 12 years to develop. It is said to have demonstrated 'efficacy in reducing hair loss, increasing hair growth and improving hair recovery and release' during the trials, which were carried out by an independent CRO in New York (AMA Laboratories, INC) that specialises in dermatological product testing.

These results make Cellmid Limited, through its subsidiary Advangen Limited, the first company to introduce a clinically-validated FGF5 inhibitor hair growth product to the market in the form of its' tonics.

The évolis tonics - one for men and one for women - are topical formulas which the website claims 'May benefit in reducing hair loss, leading to the appearance of thicker hair'. They feature botanical extracts including poterium officinale, rosa multiflora, eriobotrya japonica, ginkgo biloba and swertia chirata.

For best results, users are advised to apply three-to-five sprays of the tonic twice daily - once in the morning then again in the evening. It should be massaged into the affected areas after shampooing, and the hair can be wet or dry during application.

The manufacturers advise users 'will need to use évolis for a minimum of 16 weeks, twice per day every day' in order to see results. Continued use of évolis is also recommended to maintain any results obtained, as is complimenting the tonic with shampoos from the range which also contain botanical extracts, as well as a 'unique Catch and Release polymer to assist with volumising'.

What is FGF5?

FGF5, or 'Fibroblast growth factor 5' is a naturally occurring protein found in the body that is programmed by the FGF gene. It speeds up the hair growth cycle and determines hair length.

Restraining FGF5 has been found to extend the Anagen (growth) stage of the hair growth cycle in mammals, including cats and mice, producing long hair. As it also impacts the human hair cycle it is of significant interest to scientists researching hair loss treatments and cures.

The  Nishinihon Journal of Dermatology published a paper entitled ' "Sanguisorba Officinalis Root Extract Has FGF-5 Inhibitory Activity and Reduces Hair Loss by Causing Prolongation of the Anagen Period" in 2007. Since then many companies have tried to harness FGF5 to produce the next generation of treatments for Male Pattern Baldness and Female Hair Loss.

Whilst inhibiting FGF5 can help to prolong the hair growth phase, an excess of FGF5 has the opposite effect, leading to the hair prematurely entering the Telogen, or 'resting' phase, causing hair to fall out.

Results of clinical trials

Objective, independent clinical trials of évolis ONE were carried out on 32 otherwise healthy individuals, aged between 31 and 55, with androgenetic alopecia.

Men taking part measured between 2 and 4 on the Norwood scale, whilst female subjects registered I-2 to II-2 on the Ludwig scale of hair loss. The trials lasted 112 days (16 weeks) and products were applied twice daily.

Gravimetric Determination methods were used to analyse the impact of évolis ONE in reducing genetic hair loss over 112 days (16 weeks) with twice daily use. Findings showed this resulted in an 80.2% reduction in hair loss.

When testing the 'hair differentiation' - the ratio of growing (anagen) hairs to resting (telogen) hair follicles - results gathered based on the Van Scott “hair pluck” method found an anagen increase of 44.2% over the same period .

PhotoGrammetrix™3 measurements, a form of visual assessment using scientific photographs, used to gauge the general improvement in hair quality and volume showed an increase of 143.3%. This visual evaluation was reportedly conducted by AMA’s Institutional Review Board.

A 51 subject Repeat Insult Patch Test (RIPT) exploring skin irritation and sensitisation was also carried out by AMA Laboratories and was said to result in a “zero adverse event” report. However, évolis warns users that those 'who suffer from a skin condition such as eczema, psoriasis or sensitive skin may experience irritation and/or a dry, itchy scalp' and advises them to carry out a patch test first to assess their sensitivity.

Comment

Maria Halasz, CEO of Cellmid commented on the clinical trial results, saying “In addition to the hair count and hair loss measurements the photographs taken during the PhotoGrammetrix™ evaluation demonstrate visible improvement in overall hair quality and volume... As this product has active ingredients subject to Cellmid’s recently filed patent application, the results give us multiple opportunities to commercialise this valuable asset.”

Darren Jones, Head of Product Development at Cellmid, added, “These are very exciting and valuable results expected to support stronger clinical hair growth claims of this proprietary product. FGF5 is well recognised as the ultimate controller of hair loss. We are excited to be the first on the market with a clinically validated product range addressing FGF5” he added.

Leonora Doclis, Senior Trichologist at The Belgravia Centre said, "The exploration of FGF5 inhibitors is an innovative approach to developing new hair loss treatments and the results of évolis' in vitro tests suggest this could be an exciting area to explore. However, as these tests were carried out on a fairly small scale, it would be interesting to see wider-ranging research carried out into the efficacy of these tonics used both on their own and in conjunction with other existing hair loss treatments like minoxidil. As the évolis formula comprises four botanical ingredients it may prove a good, natural hair growth booster to use alongside medically-proven hair loss treatments".

Ingredients

Purified water, ethanol, butylene glycol, ginkgo biloba extract, eriobotrya japonica leaf extract, panthenyl ethyl ether, swertia chirata extract, glycyrrhetinic acid, citric acid, sodium citrate, maltodextrin

évolis tonic for Women: Purified water, ethanol, butylene glycol, poterium officinale root extract, rosa multiflora fruit extract, panthenyl ethyl ether, swertia chirata extract, glycyrrhetinic acid, citric acid, sodium citrate, maltodextrin

Information correct at date of publishing: May 2015