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.
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).
The study's primary end-point was to evaluate the Nerium Test Articles safety/toxicity, a) Determine if the Nerium oleander CG metabolites (Cardiac Glycosides) were being absorbed through the skin, b) If so, how much, c) If there was any significant blood pressure or heart rate changes, d) If there were changes in blood chemistry or organ system functions. Lab analysis of blood samples showed no detectable amounts of CG's and heart rate, blood pressure, blood chemistry, and CBC analysis were all non-eventful.
With regard to our review of efficacy, we found that a statistically significant number of the subjects, [70%] which were using the natural Nerium oleander-based formula found it worked better or the same as the OTC (The Nerium Test Article contained no added acids or cleansing compounds as did the OTC).