A Novel Microfiber Wipe for Delivery of Active Substances to Human Skin: Clinical Proof of Concept.

A novel technology for the delivery of active substances to the skin based on microfibers loaded with dried active substances was developed. The objective of this work was to demonstrate deposition of the active substances on the skin including concurrent cleansing properties of the wipe. As model active substance to measure deposition capacity Niacinamide was used and as parameter to measure cleansing capacities of the wipe squalene uptake was measured. Wipes loaded with niacinamide were used in the face and the forearm of 25 subjects. By means of Raman spectrometry the deposited niacinamide was analyzed before and after application. Wipes used on the face were analyzed for squalene to assess skin cleansing properties and for residual niacinamide. Forearm analysis including placebo and verum on left and right arm respectively was performed to rule out changes of the skin through application of the tissue. Measured amounts of niacinamide from face application demonstrate statistically significant results in the study population. Analysis of the wipes used show a liberation of 28.3% of niacinamide from the wipes and an uptake of 1.7 mg squalene per wipe. Results from forearm application show statistically significant differences (p < 0.05) between placebo and active for the complete study population. Sub group analyses are significant for both gender and ethnicity for face and forearm analysis respectively. Results clearly demonstrate deposition of niacinamide on the skin and the cleansing properties of the wipe. The institutional review board approved this prospective study.