EVALUATE SKIN DISINFECTANT SPRAY 209 the application of two products, and the subsequent sensory assessment occurring con- secutively on the same forearm, therefore, reduces interference between products. Each superfi cial wound was created by a sequential removal of the stratum corneum layers using the Corneofi x® tape (2 × 1.95 cm) until a clear glistening layer was visualized (at least 40 times). The TEWL measurements were taken after wound creation and before test product application. The procedure was conducted in all four test areas for the pilot study and three test areas for the pivotal study except the TEWL measurements. The sequence of wounding was I, II, III (and IV, pilot study only), and the sequence of allocation of product to each test site was randomized. FORMULATIONS AND BLINDING For both studies, the test product was a prototype disinfectant spray containing 0.13% benz- alkonium chloride and 1% menthol derivatives (menthone glycerin acetal). The reference product was the BACTROBAN® disinfectant spray (0.13% benzalkonium chloride) sourced from a market place in China. The negative control was 0.9% w/v sodium chloride solution (saline) (China Otsuka Pharmaceuticals Co., Ltd., Foshan, China). The pilot study also in- cluded a positive control (70% v/v isopropyl alcohol) this was not included in the pivotal study. The active ingredient, batch number, and expiration date of the test products are pro- vided in Table I. The sequence of product applications on wound sites (I, II, II, and IV for the pilot study and I, II, and III for the pivotal study) was randomly assigned to each subject. There were eight different sequences in the pilot study and six different sequences in the pivotal study. The randomization schedule was generated using a computerized randomization generator and provided to the site by the GSK Biostatistics Department. In the pilot study, a square fi lter paper (1.8 × 1.8 cm) (Courage + Khazaka electronic GmbH, Köln, Germany) saturated with each product was applied and left on each test Table I The Active Ingredient, Batch Number, and Expiration Date of Test Products Product Ingredients Batch No. Use By Prototype disinfectant spray 0.13% Benzalkonium chloride (active) RDMF0024B01 May 6, 2014 Menthone glycerin acetal (active) Polysorbate 20 Edetate disodium dihydrate Propylene glycol Sodium bicarbonate Purifi ed water BACTROBAN® disinfectant spray 0.13% benzalkonium chloride (active) BDB130104 January 24, 2015 Polysorbate 20 Edetate disodium dihydrate Propylene glycol Sodium bicarbonate Purifi ed water 0.9% w/v sodium chloride solution 0.9% w/v sodium chloride 1H73G1 July 1, 2016 Aqua 70% v/v isopropyl alcohol 70% v/v isopropyl alcohol 1BI0808 August 31, 2014 Aqua

JOURNAL OF COSMETIC SCIENCE 210 site for 15 s, and there was at least 10 min interval between the study product applica- tions. In the pivotal study, the product was applied by spraying twice onto the experi- mental wound from a distance of ~10 cm within 2 min of wound creation. There was at least a 30 min interval between the product applications. The product application in the pivotal study used spray instead of fi lter paper to more accurately refl ect real-life use. The examiner conducting the skin assessments had no involvement in product applica- tion and remained blinded to the identity of the investigational product. All the products were identical in appearance and packaging to maintain blinding. The subjects were also blinded to the treatment identity. ASSESSMENT TEWL MEASUREMENT (PILOT STUDY ONLY) The TEWL was measured (g/m2/h) by means of a Tewameter TM300® (Courage & Khazaka Electronic GmbH) under standard conditions, and the probe of the Tewameter TM300® was warmed up to 30.0° ± 1.0°C. Subjects were in a temperature- and humid- ity-controlled room (19°–21°C and 45–55% relative humidity) for 15 min before each TEWL measurement. SUBJECT PERCEPTION In the pilot study, subjects rated their response to the perceived product performance (cooling/fresh and pleasant feeling intensities), tolerability (stinging/burning and itching intensities), and overall rating of the product liking using a questionnaire containing fi ve-point categorical scales. For the pivotal study, subjects were asked to rate their per- ceived cooling intensity using a 100 mm VAS at four time points (immediately 3, 5, and 15 min after product application) and to rate their overall sensory liking of the product using a nine-point categorical scale. The VAS rating in millimeter (mm) was measured and recorded by one member of the site staff. SAFETY Safety was assessed through adverse events spontaneously reported by subjects or ob- served by the investigator and the TEWL measurements (pilot study only). Changes in performance and tolerance variables, e.g., cooling, burning, and itching intensities, were not classifi ed as adverse events. STATISTICAL METHODS PILOT STUDY The proportions of subjects within a treatment experiencing cooling/fresh sensation, pleasant feeling, stinging/burning, and itching sensation during 15 s of test product