Science behind nailKALM®
nailKALM® is a safe, effective anti-fungal treatment containing AMYCOT® — a unique, organic, non-toxic active ingredient naturally derived from Spirulina
AMYCOT® is a powerful natural ingredient derived from Arthrospira maxima (Spirulina), a naturally occurring micro algae (cyanobacterium). The biosource of this product has its origin in one of the earliest forms of plant life on our planet earth.
It is a microscopic, water borne, single cell plant that has been used for centuries as a highly nutritious source of food containing very high levels of essential vitamins and anti-oxidants.
The anti-fungal activity of AMYCOT® is due to a putative enzymatic action that destroys the chitin/chitosan polymers found in the fungal cell wall. Damage to the polymers causes the fungal walls to collapse, eventually killing the fungus.
Tests have shown nailKALM® stimulate the growth of the skin derived cells such as keratinocytes thus, enhancing skin, nail and hair growth. nailKALM® is naturally derived, and non-sensitising.
The discovery of AMYCOT®
The discovery of AMYCOT® was the result of a New Zealand scientist’s long term interest and work with bioactives. These are compounds produced by living organisms that have an effect on other organisms. Penicillin, the original antibiotic, is an example of such a compound.
As part of this interest he sought to develop a protective mechanism for solid-state fermentation systems, as used in the mushroom and other industries. These are subject to contamination by invading microorganisms, particularly fungi.
The main aim of the research was to find a natural alternative to chemical treatments.
The scientist commenced his research with a small range of algae and Cyanobacteria, but soon stumbled across one species that proved very effective.
It was a ubiquitous group of Cyanobacteria that lives in fresh, brackish or saline water. However, not all strains were equally effective — only one seemed to exert a powerful effect on fungi.
AMYCOT® is an antimicrobial extract derived from the microorganism Arthrospira maxima.
Clinical Trials Results
Investigator-initiated clinical trial (NY-based podiatrist, USA 2006)
Proven efficacy with 50 patient trial (including 15 patients with Type 2 diabetes) who had tinea and onychomycosis in a 90-day trial. The ages of the patients ranged from 21 to 72 years of age. The subjects were treated over a period of 90 days with 8% AMYCOT® lotion (equivalent to the current dose in nailKALM®). In all classes studied, an average of 80% of the fungal nails applied with 8% Amycot lotion demonstrated an improvement of one full class. An average of 15% demonstrated an improvement of two full classes. A remainder of 5% demonstrated either full recovery or remained unchanged. (Ref 1 below).
Investigator-initiated clinical trials (Drs. MG & AM Freeman, Australia, 2011, Australian College of Dermatology)
Cured 7 out of 10 Onychomycosis subjects, with nailKALM® after 3 month treatment and an additional subject after 6 months. (Ref 2 below).
Phase II Clinical Trial (ACUNOVA India 2010/12)
A randomised, double-blind, placebo controlled, parallel, single centre, efficacy and safety study on 28 subjects with tinea (14) and onychomycosis (10) showing significant efficacy over placebo with overall mycological cure rate of 92% against combined tinea/onychomycosis infections (severe to very severe). Onychomycosis subjects (5/5) treated with nailKALM® had 100% mycological and clinical cure rates while none of the subjects receiving placebo were cured (0/5) after 3 months treatment and another 3 months follow-up. (Ref 3 below).
Zoe* had a fungal nail infection that covered two thirds of her toenail. Four weeks after using nailKALM® twice daily a scraping was taken and no live fungi were present. Two months after treatment stopped, the damaged nail had grown out and had been replaced by a new healthy nail.
*Changed for privacy reasons
Proof of Efficacy — Efficacious anti-fungal activity
An in vitro efficacy trial was undertaken by an independent TGA licensed testing laboratory, ConMac Laboratory Services, Queensland in 2003 to compare the efficacy of AMYCOT® with established proprietary products containing various actives.
The trials confirmed that preparations containing AMYCOT show comparable efficacy with proprietary products and actives tested against test fungi and yeasts in vitro. It should be noted that in vitro results do not always translate to clinical results.
In addition to biochemical techniques, Scanning Electron Microscopy (“SEM”) was employed to investigate the mode of action of the bioactive against common dermatophytes that cause fungal conditions in humans, using in vitro and in vivo models.
A lawn of Trichoderma viride, a vigorous predator of Ascomycete fungi that preys on other fungi, was grown then sprayed with AMYCOT®.
Figure 1: Photo showing normal growth morphology of Trichoderma Viride.
Figure 2: AMYCOT® digestion of Trichoderma Viride after 24 hours showing complete digestion of the fungal cell wall leading to the formation of inert protoplasts.
Figure 3: AMYCOT® digestion of Trichoderma Viride after 5 days showing that all that is left is a mass of dry cytoplasmic matter.
(Figures 1-3) taken before spraying and at 1-day and 5-day intervals following application demonstrate graphic evidence of the rapid and complete destruction of fungi by AMYCOT®.
References:
1. Data in file.
2. Freeman AM and Freeman MG. Nailkalm (Arthrospira maxima) for the treatment of dermatophyte nail infections. Australasian Journal of Dermatology 2011:52 Suppl 1:25.
3. Data in file. This trial has been registered with the clinical trial registry - India (CTRI; registration number: CTRI/2012/03/002522). Manuscript in preparation.
4. Data in file.
