Cellmid (ASX: CDY) says it has received strong positive results in all measured areas of its independently conducted, randomised, blinded and placebo controlled human clinical study of hair-loss formulation, évolis ONE.
In the 32 patient study, évolis ONE has shown a statistically significant 80.2 per cent reduction in hair loss over 112 days (16 weeks) with twice daily use.
Hair differentiation (or anagen/telogen ratio, a measure of growing versus resting hair follicles) improved with an increase of 44.2 per cent in growing follicles during the same period, as analysed by the Van Scott 'hair pluck' method .
Hair release and recovery (overall improvement in hair quality and volume) was quantified by PhotoGrammetrix measurements and has shown an improvement by a statistically significant 143.3 per cent.
Individuals included in the study experienced “patterned baldness” of 2 to 4 on the Hamilton-Norwood scale (men) and I-2 to II-2 on the Ludwig scale (women) of hair loss.
Study participants were otherwise in general good health and within the healthy weight range, aged 31 to 55 years.
The trial was conducted by an independent clinical research organisation, the New York-based AMA Laboratories, which specialises 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” reports.
“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” said 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” she added.
“These are very exciting and valuable results expected to support stronger clinical hair growth claims of this proprietary product” said Darren Jones, Head of Product Development at Cellmid.
“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.
FGF5 and its inhibitors FGF5 is recognised as the ultimate regulator of hair cycle and hair length in humans, said the company in a statement.
"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," it said.