Assessing the Sting Potential of Film Forming Barriers

The barrier property of skin can be compromised by a variety of agents/activities, such as adhesive trauma, irritation caused by urine and/or fecal incontinence, digestive juices, and shear/friction. All of which can lead to a wound.  Film forming skin protectants have been used to minimize damage to the skin. The purpose of this study is to evaluate a new (non-stinging) formulation for its stinging potential against a pre-existing no sting formulation, 70% IPA and saline (+/-controls, respectively). Twenty-one volunteers (50 years of age and older) were recruited. Four, 1-inch x 2-inch test sites were located on the upper back with two sites being on each side of the back. A hypoallergenic cloth adhesive tape (1” x 2”) was applied to 4 test sites on the back (2 on each side) and removed, repeatedly using new tape each time. Sites were stripped until “glistening.” Using this technique (4) 1 inch x 2 inch irritated sites were created on the back (2 on each side). The test formulations and controls were applied one at a time to the four challenged sites. The two test barrier film products were randomly applied to two of the four challenged test sites as were the alcohol and saline (controls). The subjects were asked to rate the amount of burning/stinging immediately after each treatment using a 0-4 scale. Application of alcohol to challenged skin produced a strong sting response while application of saline elicited little or no response. Neither of the no-sting formulations was found to elicit a statistically significant sting response relative to each other and/or saline. There was a statically significant difference when compared to the alcohol control.  Based upon this study it can be concluded that the new formulation produces little or no stinging and is comparable to saline in this respect.