A Two Phase Study to Examine the Efficacy and Absorption of a Topical Anti-Aging Product when used in Conjunction with an Ultrasonic Facial Device

BACKGROUND

To meet the public demand for achieving significant, noninvasive anti-aging effects, numerous devices employing a range of energy technologies have been recently developed. One of these technologies is ultrasound (US), this type of US (Cosmetic US) uses much lower ultrasound energy to treat the superficial layers of the skin compared to medical US. Cosmetic US use 0.4–1.2 J/mm2 of energy, a frequency of 4–10 MHz, and a focal depth of only 1.5–4.5 mm. Despite its lower energy, Cosmetic US is capable of heating tissue and disrupting stratum corneum junctions.

The effects of Cosmetic US are under described in the literature and there are very few and not well described home use devices. Furthermore the utility of these at home devices in conjunction with typical topical formulation is currently unknown; therefore we undertook two clinical studies to evaluate the JeNu Infuser™ (Hermosa Beach, California, USA) in conjunction with a market leading anti-aging topical eye product.

METHODS

We under took two clinical trials, the first (phase I) was aimed to determine if the use of an at home Cosmetic US device in conjunction with a typical anti- aging topical product would result in the ability of the device to “drive” the compound further into the skin and as a second aim, the study was designed to determine if the device could enhance the absorption of a common ingredient (Vitamin C) into the skin. The second (phase II) study was to then to perform a study comparing the anti-aging topical products efficacy with or without the concomitant use of this device in order to ascertain if the results of the first study (phase I) had any relevance to the efficacy of the product. Phase I utilized tape stripping, dansyl chloride staining and HLPC for vitamin C concentrations. Phase II utilized a randomized split face design and standard measurements of expert visual grading, corneometer, cutomeeter, SIAscope and image analysis.

RESULTS

Phase I of the study enrolled twenty subjects (mean age 43.9 ± 10.5). Dansyl chloride acid revealed that while the topical product both with and without the use of the cosmetic US device was able to absorb well into the skin (15 layers), the amount of product found at the lower level of the skin (10-15) was 6 times as concentrated with the use of the device compared to that without the use of the device (p<0.001). Additionally, quantitative HLPC was able to determine that approximately ten times the amount of vitamin C was found at the 7th level of the skin (tape strips) when the device was used compared to the product alone (p<0.001). Phase II of the study enrolled forty females subjects with signs of photo aging (mean age 46.7 ± 10.2). Those surface areas treated with the combination of the topical anti-aging product and concomitant use of the Cosmetic US device was shown to have statistically significant improvements compared to the use of the topical products alone in the areas of; radiance (P=0.13), texture/smoothness (p<0.001), crow’s feet lines/wrinkles (p0.043) after four weeks of use. Furthermore instrumental analysis revealed similar improvements in those using the device; Cutometer firmness (p=0.005) and elasticity (p=<0.001). Image analysis revealed improvements over topical product alone in terms of wrinkle length, width and severity as well as the number of fine lines.

CONCLUSIONS

The use of a Cosmetic US device results in improved absorption of topical formulations and common ingredients (Vitamin C). This improved absorption has been shown to improve subject outcomes in terms of product performance in photo aged skin.

This study was conducted by IRSI International Research Services Inc. (http://www.irsi.org/) and presented at the 2016 International Society for Biophysics and Imaging of the Skin World Congress (http://www.isbs2016.com/).