JOURNAL OF COSMETIC SCIENCE 212 The Wilcoxon signed-rank test results showed the difference in rating between products for all attributes (Table III). This was a pilot study and not powered to show statistically signifi - cant differences between treatments. The only statistically signifi cant difference observed was between the negative (sodium chloride solution) and positive control (70% isopropyl alcohol) in relation to the “stinging/burning sensation” in favor of the negative control. No itching sensation was recorded by subjects after applying any of the four products. PIVOTAL STUDY The cooling sensation VAS score raw means are plotted in Figure 2 by treatment and as- sessment time for all treatments. Treatment comparisons are provided in Table IV. Statistically signifi cant product differences were observed between the prototype for- mulation and the BACTROBAN® disinfectant spray at 3 and 5 min after application Table II Pilot Study Subject Sensory Questionnaire Responses Prototype disinfectant spray (N = 12) BACTROBAN® disinfectant spray (N = 11) 70% isopropyl alcohol (N = 12) 0.9% sodium chloride solution (N = 12) N (%) N (%) N (%) N (%) Cooling/Fresh sensation None 0 0 0 0 Weak 2 (16.7) 1 (8.3) 4 (33.3) 2 (16.7) Moderate 5 (41.7) 4 (33.3) 3 (25.0) 2 (16.7) Strong 4 (33.3) 7 (58.3) 4 (33.3) 4 (33.3) Extremely strong 1 (8.3) 0 1 (8.3) 4 (33.3) Pleasant feeling Disagree strongly 0 0 1 (8.3) 0 Disagree moderately 1 (8.3) 0 2 (16.7) 0 Neither agree nor disagree 4 (33.3) 1 (9.1) 0 5 (41.7) Agree 7 (58.3) 10 (90.9) 8 (66.7) 7 (58.3) Strongly agree 0 0 1 (8.3) 0 Stinging/Burning sensation None 4 (33.3) 5 (45.5) 4 (33.3) 7 (58.3) Weak 5 (41.7) 3 (27.3) 3 (25.0) 4 (33.3) Moderate 3 (25.0) 3 (27.3) 2 (16.7) 1 (8.3) Strong 0 0 3 (25.0) 0 Unbearable 0 0 0 0 Itching sensation None 9 (75.0) 10 (90.9) 10 (83.3) 9 (75.0) Weak 3 (25.0) 1 (9.1) 2 (16.7) 3 (25.0) Moderate 0 0 0 0 Strong 0 0 0 0 Unbearable 0 0 0 0 Overall product rating Dislike very much 0 0 0 0 Dislike moderately 0 0 3 (25.0) 0 Neither like nor dislike 5 (41.7) 4 (36.4) 5 (41.7) 7 (58.3) Like moderately 6 (50.0) 6 (54.5) 3 (25.0) 5 (41.7) Like very much 1 (8.3) 1 (9.1) 1 (8.3) 0

EVALUATE SKIN DISINFECTANT SPRAY 213 and in average AUEC in favor of the prototype formulation. Statistically signifi cant product differences were also observed in favor of the prototype formulation compared with the negative control (saline) at 3, 5, and 15 min after application and in average AUEC. For overall liking score, the raw means of the three treatments are plotted in Figure 3, and treatment comparisons are provided in Table V. There were no statistically signifi cant differences observed. The comparison between prototype formulation and negative con- trol (saline) approached signifi cance (difference 0.4 and p-value 0.0561). SAFETY RESULTS PILOT STUDY No adverse event was recorded. At the Day 4 and Day 8 follow-up visits, mild erythema was observed in 50% of subjects localized at one or more of the wound sites. The fi ndings were observed across all treatment groups. The examining clinician and Principal In- vestigator diagnosed these signs as being part of the normal wound healing, infl amma- tory response with no causal relationship to test products. These observations were not recorded as Adverse Event (AEs) per the protocol defi nition of an AE as an untoward/ unintended medical occurrence. The four treatment groups had similar TEWL means Table III Pilot Study Comparison of Treatments using Wilcoxon Signed-Rank Test Prototype disinfectant spray (N = 12) BACTROBAN® disinfectant spray (N = 11) 70% isopropyl alcohol (N = 12) Cooling/Fresh sensation BACTROBAN® disinfectant spray 0.7500 70% isopropyl alcohol 0.6875 0.5625 0.9% sodium chloride solution (N = 12) 0.1825 0.1758 0.4375 Pleasant feeling BACTROBAN® disinfectant spray 0.1250 70% isopropyl alcohol 1.0000 0.5625 0.9% sodium chloride solution (N = 12) 1.0000 0.2500 1.0000 Stinging/Burning sensation BACTROBAN® disinfectant spray 1.0000 70% isopropyl alcohol 0.4082 0.5313 0.9% sodium chloride solution (N = 12) 0.1875 0.3594 0.0313 Itching sensation BACTROBAN® disinfectant spray 1.0000 70% isopropyl alcohol 1.0000 1.0000 0.9% sodium chloride solution (N = 12) 1.0000 1.0000 1.0000 Overall product liking BACTROBAN® disinfectant spray 1.0000 70% isopropyl alcohol 0.0625 0.1250 0.9% sodium chloride solution (N = 12) 0.3750 0.3750 0.5625