ST&T initiated a pilot study on human subjects for spot application on Age/Liver Spots and Actinic Keratosis with the Nerium SkinCare topical formulation. The specific aim of this study was to evaluate the safety and efficacy of a topical natural Nerium oleander-based solution, in volunteers which have aged and sun-damaged skin, with evidence of solar lentigines (age/spots) and/or actinic keratosis.
Safety was judged on the review of the data for any adverse reactions to solution and absorption rate of cardiac glycosides into the volunteer’s bloodstream. Volunteers were instructed thoroughly about solar lentigines and actinic keratosis lesions, and were provided an examination for other related skin conditions. They were instructed in the correct application of the solution twice a day at home on designated areas, and provided a camera so they could take two pictures of treated areas at home, the diligent use of daily patient diaries as well as to contact the ST&T Center for Wellness Research Clinic immediately, should any negative side effects occur.
Efficacy was judged via 50 power skin microscope to inspect the treated area with regard to the extent of diminishing pigmentation (fading of color) in solar lentigines lesions (e.g. black to brown). Clearance of actinic keratosis lesions, and any other skin conditions, treated, or untreated were also noted.
It was ST&T’s intent to observe the safety and efficacy of the solution for use in individuals who exhibit skin damage due to age, sun and environmental conditions, and who have exhibited such conditions as solar lentigines (age spots) and/or actinic keratosis lesions.
Primary Endpoint - Safety Observations: ST&T utilized blood chemistry and CBC analysis whereby they compared participant’s baseline results with measurements throughout the study. Participant blood samples were taken on day one (1) (one hour after cream application), day seven (7), and on day thirty (30) of product use to test for oleandrin absorption and accumulation in the blood. Analysis for CG’s (Cardiac Glycosides) in blood at each blood 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 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 CGs, and heart rate, blood pressure, blood chemistry, and CBC analysis were all non-eventful. With regard to efficacy, ST&T was surprised to find that there were a statistically significant number of subjects which reported reduction in color and size of their age spots in only a thirty (30) day period as the Nerium test article contained no bleaching or whitening component.