| ST&T initiated a pilot study on human subjects that provided for testing a topical application for
Cold Sores (HSV-1) utilizing the Nerium SkinCare topical formulation Nerium CS™. ST&T initiated this pilot study to test the safety and efficacy of the Nerium natural topical
oleander-based antiseptic solution, Nerium CS™, to help promote and speed the healing, reduce
symptoms, and/or to mitigate and reduce pain and the spreading of skin irruptions or wounds to
mouth areas [lip lesions, pimples, blemishes, fever blisters, or active cold sore(s)]. Study Aim/Purpose: The specific aim of this study was to evaluate the safety and efficacy of the natural Nerium topical
oleander-based antiseptic solution, Nerium CS™, in volunteers with lip lesions, pimples, blemishes,
fever blisters, or active cold sore(s). Subjects enrolled were all healthy, with no significant medical
history. All had lip lesions, pimples, blemishes, fever blisters, active cold sore(s) thought to be
related to the Herpes Simplex Virus type 1 [HSV-1] (in lab cultures/tests of volunteers, 80% showed
a positive results for HSV-1 and there were 20% who had sores/lesions related to another underlying
cause). It is estimated that recurrent HSV -1 (cold sores of the mouth area) alone affects approximately 20-40%
(some figures suggest as high as 80%) of the adult population in the United States. The frequency of
the disease among affected individuals varies from rare episodes to 12 or more recurrences per year.
Although there are a variety of intravenous, oral and topical antiviral drug agents tested in clinical
research settings which have shown efficacy against herpes lesions, there is a need for over-the-counter
natural antiseptic products with proven efficacy, to help lessen and/or mitigate the symptoms. Background-Viral Related Skin Eruptions/Vesicles: Upon contact with the body, HSV-1 penetrates susceptible cells and begins to replicate itself with
cell nuclei, destroying host cells. Clinically, there are five stages of this type of skin infection: Prodromal Stage: a generalized precursor of herpes infection becomes evident about 6 to 48
hours before a cold sore is visible, subject may feel tingling, burning, itching, numbness, tenderness,
or pain in the affected area, even symptoms consisting of mild malasia, fever and localized
lymphadenopathy, which can occur with HSV-1. The infection then proceeds into a localized skin reaction. Erythema Stage: an erythematous reaction, or localized redness without induration. Papular Stage: begins with induration, or hardening of the skin. Vesicle Stage: The vesicular stage begins with destruction of host cells causing painful eruption of
vesicles. Ulcer Stage: The blisters ulcerate and form a crust, drying out and healing rapidly. When the crust falls
off, the virus is no longer transmissible, or contagious. The mean duration of recurrence is 7-12 days, and sometimes up to 2 weeks or more. The viral
particles persist in its latent form, without symptoms, in the neural ganglia until recurrence. Viral
replication usually occurs at the same site, triggered by a variety of different factors, such as
sunlight, physical, environmental or emotional stress and cell destruction with subsequent vesicle
formation begins again. It is suggested that viral shedding begins prior to vesicle formation. Clinical Summary: In the study of this natural Nerium oleander-based topical antiseptic solution, Nerium CS™, it
was found that its effectiveness help promote and speed the healing, reduce symptoms, and/or
to mitigate and reduce pain and the spreading of skin irruptions or wounds to outside mouth areas
in form of lip lesions, pimples, blemishes, fever blisters, or active cold sore(s) / HSV-1. The Nerium
topical solution was faster than or equal to traditional drug therapies, though it was found that its
greatest success on inhibiting and/or clearing of vesicles was if it is applied early, before or at the
early onset of the outbreak. Participant blood samples were done at visit day 1 (screening) and at the study conclusion (their
last visit). A comprehensive blood chemistry panel was run to test for oleandrin absorption and
accumulation in the blood. From results of the blood test, there were no adverse reactions noted,
blood analysis showed all subjects within normal ranges, and that there was no detectable CG’s
in the blood. The subjects were enrolled for the natural Nerium CS™ treatment duration of 10-26 days depending
on the severity of cold sore and time they took to heal. On average, subjects where the Nerium
antiseptic solution was applied at stage 1-2 (Prodromal or Erythema), rarely progressed to other
stages and vesicles cleared within two days. Subjects who were seen in stage 3-4 (Papular or
Vesicle) before applying the antiseptic solution experienced a healing time of two to four days on
average, other subjects presenting at stages 3, 4, or 5 (Papular, Vesicle, or Ulcer) had varying
results from 3-5 days on average and up to 10 days or more (likely dependent upon the infection
or viral load, environmental considerations, i.e. stressors, diet, sun [UV radiation] exposure,
etc.). Solution effectiveness was apparent, (faster than or equal to traditional drug therapies),
though it had greatest success on inhibiting and/or clearing vesicles if applied before or at the
early onset of the outbreak. |
