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allied
academies
Journal of Dermatology Research and Skin Care | Volume 2
May 14-15, 2018 | Montreal, Canada
Spring Dermatology &
Skin Care Expo Conference
A
MYCOT® is a bioactive extract derived from a strain
of Spirulina
(Arthrospira maxima
), a
cyanobacterium
,
which is commonly used as food supplement and has been
consumed for centuries by the Aztecs in Mexico and tribes in
Africa. AMYCOT® is produced through a proprietary process
which enriches for the bioactive(s). The complex mixture
contains a variety of molecules known to have anti-fungal
activity as well as a unique activity targeting chitin, a cell wall
component present in a broad range of fungi including yeasts.
The fungicidal property of AMYCOT® is supported by electron
microscopic studies showing rupture of test fungi after a few
days as well as
in vitro
zone inhibition studies against a variety
of dermatophytes and yeasts. Preclinical
in vitro
studies
including use of an
in vitro
3D human epidermis model have
shown that AMYCOT® is non-toxic and non-allergenic with
stimulation of skin cell growth properties. Furthermore, the
bioactive extract demonstrates anti-inflammatory activity
by reducing secretion of IL-1 alpha, a cytokine central to skin
inflammation (unpublished results). Previous open-label
studies by independent investigators demonstrated efficacy of
AMYCOT® against a variety of dermatological fungal infections
such as tinea and onychomycosis (2; unpublished results). To
further confirm these studies, a single-center, randomised,
double-blind, placebo-controlled clinical study was conducted
in India. AMYCOT® was formulated as a lotion (8% AMYCOT®)
to treat onychomycosis and as a cream (12% AMYCOT®) against
tinea infections. The study’s sample size was determined from
a previous study on a cream and lotion that observed an 81%
cure rate for the experimental drugs and an assigned 10% IGA
response of ‘cleared’ or ‘excellent’ for the placebo group using
a two-group Fisher’s-exact test of equal proportions. Based
on these assumptions, there is over 95% power to detect a
significant difference between the treatment and placebo
groups with 14 subjects per group (28 subjects overall) at 5%
level of significance, and assuming a 20% dropout rate. From
screening 50 potential patients, a total of 28 patients, 18 with
tinea and 10 with onychomycosis were randomized in a ratio
of 1:1 to treatment or placebo group. All were positive for all
three parameters constituting mycological cure, which was
assessed, was assessed by potassium hydroxide (KOH) smear,
fungal culture and live spore count. Clinical cure was defined as
Investigator global assessment (IGA) responseof ‘cleared’ (100%
improvement) or ‘excellent’ (>90% improvement). At the end of
treatment, all three parameters were negative in the treatment
arm, while KOH smear was positive in all subjects, and culture
and live spore count were positive in six of them in the placebo
arm. The treatments showed a significant improvement in all
three parameters (p<0.0001, 0.019 and 0.019 respectively).
At the end of the study, clinical cure was achieved in 11/14 of
the tinea subjects and 5/5 of onychomycosis subjects in the
treatment arms, while none in the placebo arm. No treatment-
relatedadverseeffectswereobserved inbothgroups. Additional
examples onother subjectswithonychomycosis and paronychia
will be presented including the successful use of the bioactive
extract against acne and pompholyx based on AMYCOT®’s
anti-inflammatory and skin repair properties. nailKALM® (8%
AMYCOT®) lotion and skinKALM® (12% AMYCOT®) are listed
with the Australian TGA (Therapeutic Goods Administration).
Speaker Biography
Leodevico (Vic) Ilag is a Chief Scientific Officer and more than 20 years of biotech
experience in the discovery and development of biologics and diagnostics serving in
multiple senior executive roles in R&D and business development with several biotech
companies in Australia and Europe.
e:
vilag@xerion.com.auLeodevico (Vic) L Ilag
Xerion Limited, Australia
AMYCOT®: A novel bioactive extract from
Spirulina
with multi-functional properties
shows clinical efficacy against onychomycosis and tinea infections; And its
implications for other dermatological conditions
Notes: