Positive clinical study results reported for évolis ONE – a hair growth product using novel FGF5 inhibitor

Cellmid Limited, an Australian biotechnology company, has reported strong positive results in all measured areas of its independently conducted, randomised, blinded and placebo controlled human clinical study of their hair growth product, évolis ONE.

The 32 patient study was conducted with Cellmid’s novel and proprietary FGF5 inhibitor formulation, évolis ONE, which is a fully optimised, GMP manufactured and market ready product. FGF5 regulates hair cycle and hair length in humans. Expressed by macrophage-like cells surrounding the hair follicle, it acts by triggering the dermal papilla to transition from growing (anagen) to resting (telogen) phase. Overexpression of FGF5 induces hair follicles to undergo premature entry into catagen phase and fall out. 

Using Gravimetric Analysis, évolis ONE showed a statistically significant 80.2% reduction in hair loss over 112 days (16 weeks) with twice daily use. Hair differentiation improved with an increase of 44.2% in growing follicles during the same period, as analysed by the Van Scott “hair pluck” method.  Hair release and recovery was quantified by PhotoGrammetrix™ measurements and showed an improvement by a statistically significant 143.3%.  

The trial was conducted by AMA Laboratories, INC. in New York, a leading independent CRO specialising in dermatological product testing. The efficacy study followed a 51 subject Repeat Insult Patch Test (RIPT) to assess safety by evaluating skin irritation and sensitisation. The safety study, also conducted by AMA Laboratories, resulted in a “zero adverse event” report.

évolis ONE demonstrated visible improvement in overall hair quality and volume

“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” added Maria Halasz, CEO of Cellmid. “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, said, “These are very exciting and valuable results expected to support stronger clinical hair growth claims of this proprietary product….We are excited to be the first on the market with a clinically validated product range addressing FGF5.” 

For more information about Cellmid, please visit cellmid.com.au.