ST&T initiated a pilot study on human subjects that provided an opportunity to test the Nerium SkinCare topical formulation on a still larger surface area of skin and evaluate its soothing healing effect on Sunburn. In this study, the Nerium SkinCare formulation was also tested against a typical sunburn treatment OTC product already in the market place. The specific aim of this study was to evaluate the safety and efficacy of the topical natural Nerium oleander-based solution in volunteers exhibiting mild to moderate sunburn.
Safety parameters were set to assess evidence of adverse reactions to the solution and any absorption of cardiac glycosides into the volunteer’s bloodstream. Observations were also made via full blood chemistry and CBC for any variations in blood chemistry or organ function. Volunteers were instructed thoroughly at the ST&T Center for Wellness Research Clinic about sunburn, the correct application of the solution (twice a day) on sunburned areas of skin, the requirement to document progress via taking of two pictures daily of the treated areas with a digital camera, and the diligent documentation of their product use via the daily volunteer diaries as well as to contact the ST&T Center for Wellness Research Clinic immediately, should any negative side effects occur (Volunteer captured digital data was
designed more as a mechanism to help promote compliance, and visually to capture and measure healing progress.).
Efficacy parameters were set to assess improvement of skin appearance (reduction of redness and inflammation), skin sensitivity, and reduction of any other physical discomfort, and/or flaking of skin.
Although the focus of this study is on sunburn, volunteers who asked to use the study solution on other areas of skin, or use it for skin conditions not related to the study focus were allowed as long as they documented the applications in the volunteer’s journal, and in advance of use consulted the ST&T physician 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 to detect CG absorption, toxicity, or any organ system changes. 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 absorption and accumulation in the blood. Some subjects were observed for inflammation, redness, rash, or indications of allergic reactions within normal ranges or were explained by diet or other causes, and the analysis for CG’s in blood at each draw period all resulted in ND (none detected).
With respect to our review of efficacy, we found that more than double the number of subjects who used the Nerium SkinCare cream experienced better results than the OTC product (40% vs.15% respectively), and it was interesting that some forty-five percent (45%) of the subjects found the OTC and Nerium product worked the same. This represents a total of eighty-five percent (85%) of the subjects that found the natural Nerium SkinCare formula worked better or the same as the OTC product.
Since the natural Nerium oleander-based product contained no "additives" like the OTC product (i.e. Tea Tree Oil, Vitamins A, B, D, and Collagen), it originally was not anticipated that the Nerium SkinCare product would out perform the OTC product.
ST&T suggested that these results should encourage further study on the Nerium oleander-based compound as a therapeutic aged and sun damaged skin treatment. It also suggested that if there were other known therapeutic vitamins and agents added to the Nerium SkinCare formula, that its performance could be further enhanced.