ST&T initiated a pilot study on human subjects that provided an opportunity to test the Nerium
SkinCare topical formulation on
a larger surface area of skin and another problem skin condition
called
Acne Vulgaris. In this study the Nerium SkinCare formulation was also tested against a
well-known
acne product already in the market place. The specific aim of this study was to evaluate
the safety and efficacy of this topical natural Nerium oleander-based solution in volunteers with Acne Vulgaris.
Safety was judged on the review of data for any adverse reactions to solution and absorption rate of
cardiac
glycosides into the volunteer’s bloodstream. Volunteers were instructed thoroughly at the ST&T Center
for Wellness Research Clinic about the treatment of their Acne Vulgaris. They were shown how to
apply the solution twice a day on blemished areas, and asked to take two pictures of treated areas
with a digital camera. Subjects were also instructed on the importance of the diligent use of daily
volunteer diaries as well as to contact the ST&T Center for Wellness Research Clinic immediately
should they experience any negative side effects.
Efficacy was judged on the review of data with respect to the healing and improvement in skin
appearance (diminishing of whiteheads, blackheads,
papules, and pustules).
Although the focus of this study was on Acne Vulgaris, volunteers who wanted to use the study
solutions on other areas of skin, or use it for skin conditions not related to the study focus were
allowed to do so, as long as use was documented in the volunteer’s journal, and pre-approved by
our medical technician or study coordinator.
Study Observations:
Primary Endpoint - Safety Observations: ST&T utilized blood chemistry and CBC analysis
whereby a comparison was made of the participant’s baseline results with measurements taken
throughout the study. Participant blood samples were taken on day one (1) (one hour after cream
application), day seven (7), day fifteen (15), and on day thirty (30) of product use to test for
oleandrin (CG) absorption and accumulation in the blood. In addition, subjects were observed for
inflammation, rash, or tenderness. Analysis for CG’s in blood at each draw period all resulted in ND
(none detected).
