JOURNAL OF COSMETIC SCIENCE 204 (30) N. Kollias, R. Gillies, M. Moran, I. E. Kochevar, and R. R. Anderson, Endogenous skin fl uorescence includes bands that may serve as quantitative markers of aging and photoaging, J. Invest. Dermatol., 111, 776–780 (1998). (31) C. Jeanmaire, L. Danoux, G. Pauly. Glycation during human dermal intrinsic and actinic ageing: An in vivo and in vitro model study, Br. J. Dermatol., 145, 10–18 (2001). (32) S. J. Hoonhorst, A. T. Lo Tam Loi, J. E. Hartman, E. D. Telenga, M. van den Berge, L. Koenderman, J. W. Lammers, H. M. Boezen, D. S. Postma, and N. H. Ten Hacken, Advanced glycation end products in the skin are enhanced in COPD, Metabolism, 63, 1149–1156 (2014). (33) K. Nomoto, M. Yagi, S. Arita, M. Ogura, and Y. Yonei, Skin accumulation of advanced glycation end products and lifestyle behaviors in Japanese, Anti-Aging Med., 9, 165–173 (2012). (34) M. Fu, K. Wells-Knecht, J. Blackledge, T. J. Lyons, S. R. Thorpe, and J. W. Baynes, Glycation, gly- coxidation, and cross-linking of collagen by glucose: Kinetics, mechanisms, and inhibition of late stages of the Maillard reaction, Diabetes, 43, 676–683 (1994). (35) J. V. Hunt, R. T. Dean, and S. Wolff, Hydroxyl radical production and autoxidative glycosylation - Glucose autoxidation as the cause of protein damage in the experimental glycation model of diabetes mellitus and ageing, Biochem. J., 256, 205–212 (1988). (36) G. Rhie, M. H. Shin, J. Y. Seo, W. W. Choi, K. H. Cho, K. H. Kim, K. C. Park, H. C. Eun, and J. H. Chung, Aging- and photoaging-dependent changes of enzymic and nonenzymic antioxidants in the epidermis and dermis of human skin in vivo, J. Invest. Dermatol., 117, 1212–1217 (2001). (37) D. Qu and Y. Park. Skin youthfulness index – A novel model correlating age with objectively measured visual parameters of facial skin, IFSCC Mag., 17(3), 9–16 (2014). Footnote: IRB review of the study. IRB review of the study: This was a skin assessment study conducted on volunteers using a medical device for diagnostic use that has been deemed of no signifi cant risk. As per the Food and Drug Administration Information Sheet Guidance “Signifi cant Risk and Nonsignifi cant Risk Medical Device Studies,” the following exemption for IRB approval applies to this study: …. diagnostic device studies (e.g., in vitro diagnostic studies) are exempt from the requirements of 21 CFR Part 812 under certain circumstances. The study is exempt as long as the sponsor complies with the requirements at 21 CFR 809.10(c) for labeling, and if the testing: (i) is noninvasive (ii) does not require an invasive sampling procedure that presents signifi cant risk (iii) does not by design or intention introduce energy into a subject and (iv) is not used as a diagnostic procedure without confi rmation of the diag- nosis by another, medically established diagnostic product or procedure. 21 CFR 812.2(c)(3). Therefore, while we followed guidelines of good clinical practices including informed consent and appropriate legal oversight, we did not seek an IRB approval as per the previ- ously mentioned exemption.

J. Cosmet. Sci., 68, 205–217 (May/June 2017) 205 Two randomized studies to evaluate the cooling sensation, consumer liking, and tolerability of a skin disinfectant spray PEILI GONG, NAN WANG, LEI GUAN, and WEI LAI GlaxoSmithKline (China) Investment Co, Beijing, China (P.G.), GlaxoSmithKline Consumer Healthcare, Brentford, United Kingdom (N.W.), Guangzhou Landproof Testing Technology Co. Ltd., Tianhe District, Guangzhou, China (L.G.), and Department of Dermatology, The Third Affi liated Hospital, Sun Yat-Sen University, Guangzhou, China (W.L.). Accepted for publication March 24, 2017. Synopsis The aim of these two clinical studies was to evaluate the sensory characteristics and irritation potential of a prototype disinfectant spray (containing 0.13% w/v benzalkonium chloride and a cooling agent) in subjects with experimental wounds. The pilot study was a single center, “replicated latinClinicalTrials. ClinicalTrials. square design,” randomized and double-blinded study. The pivotal study was a single center, randomized, controlled, crossover, double-blinded study, following a direct comparison test design of the study products. The experimental wounds were generated using sequential tape strippings of the forearm skin before product application. The test product was compared with the currently marketed BACTROBAN® disinfectant spray, negative control (0.9% w/v saline), and positive control (70% w/v isopropyl alcohol, pilot study only). The pilot study was intended to inform the study design and sample size for the pivotal study. The pilot study demonstrated that the positive control product delivered signifi cantly more irritancy (stinging /burning sensory) than the negative control product on the experimental wound, which verifi ed the integrity of the wound model. The results of the pivotal study suggested that the prototype formulation delivered signifi cantly more cooling sensation than both BACTROBAN® disinfectant spray and negative control at 3 and 5 min after product application, and overall for a 15-min period after application. No statistically signifi cant differences in product liking were observed between the prototype disinfectant spray and the BACTROBAN® disinfectant spray or negative control. The prototype disinfectant spray, BACTROBAN® disinfectant spray, and control products were well-tolerated in these studies. Address all correspondence to Wei Lai at drlaiwei@163.com. GlaxoSmithKline (China) Investment Co., Ltd sponsored this study and was involved in the study design and clinical operation. Prof. Wei Lai has been an advisory board member for GSK. Guangzhou Landproof Testing Technology Co. Ltd. conducted the experiments and initial effi cacy evaluation. All authors report no com- peting interests. ClinicalTrials.gov Identifi er: NCT02106403. ® BACTROBAN® is a registered trademark owned by GSK group of companies.