Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309
Status:
Not yet recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
A sufficient number of subjects will be entered into testing to complete 42 subjects per each
of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168
abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and
control material) will be evaluated using the standardized ASTM E1173 test method. Following
a 14-day restriction period, subjects will be sampled for baseline, 10 minutes, 6 hours, and
24 hours post application (subjects will not be sequestered) for microbial reduction
evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and
groin: ≥ 5.0 log10 CFU/cm2.