Skin Irritation and Sensitization Study

Consumer products or raw materials designed for repeat use on the skin may prove to be irritants or sensitizers for certain individuals. A standard method for evaluating this potential is the Repeat Insult Patch Test (RIPT) carried out on a selected panel. The panel of 50 individuals is screened to avoid members who are under a doctor’s care, who may have existing skin or systemic conditions, or who are taking medications that may interfere with test results.

 

The resulting panel covers an age range of 18 – 66, 12 men / 38 women, Caucasian, Hispanic, and Asian demographics. Patches are semi-occlusive to allow for air flow similar to what might be expected for light clothing. A set amount of derma-glove is applied to back between the shoulder blades, the patch is then applied and the panelist is instructed not to bathe or expose the area to direct sunlight. After 24 hours the patch is removed and visually evaluated by trained technicians using the following scoring scale.

 

This procedure is repeated for three weeks until nine 24 hour exposure scores have been recorded. A tenth test is run where a similar protocol is followed for application and dose but the patch is now evaluated at 24 hours and 48 hours. This is only done if the panelist(s) do not have a test score above 2.

 

The results indicate that derma-glove®, as evaluated by the RIPT protocol, is a non-primary irritant and a non-primary sensitizer. Not a single test panelist showed any indication of an adverse reaction. This is a stunning result considering the level of alcohol in an FDA registered product. The inclusion of Invis-O-Bond® in the derma-glove® product line provides the health care benefits of a hand sanitizer with none of the irritation properties.