Nancy A. Monteiro-Riviere, Center for Cutaneous Toxicology and Residue Pharmacology, and the Department of Clinical Sciences, North Carolina State University, Raleigh, NC

The purpose of this study was to objectively assess in a randomized controlled experiment the efficacy of ProtèqueÒ Skin Protection Lotion to modulate sodium lauryl sulfate (SLS) induced irritant contact dermatitis in a well characterized swine model. Protèque is a non-corticosteroid lotion consisting of dimethicone, triclosan (Irgasan DP300), tocopheryl acetate, Aloe Vera gel, and Lonicera Japonica in a proprietary base formulation. SLS (1 and 3%) was applied in 4.0cm2 Hill Top Chambers on the backs of weanling Yorkshire swine (n=4/trt). Protèque was applied 15 minutes before (pretreatment) or immediately after SLS. The effect of cleansing skin before application, and the efficacy of a Protèque formulation without triclosan was evaluated. Finally, the ability of Protèque to modulate UVB-induced photo-irritation was also assessed. SLS reproducibly induced a Draize level 2-3 erythema in non-treated control sites. Application of Protèque lotion significantly (p<0.05) blocked erythema, especially when applied after SLS. Results were consistent for both 1 and 3% SLS. The use of cleanser, as well as Protèque without triclosan, did not increase efficacy. UVB alone produced a Draize level 3 erythema. Protèque pre-treatment reduced this to a level 1 response, as well as significantly lowering the histological index of skin damage and the number of UVB-induced sunburn cells from 50 (control) to 3 (treated). These studies clearly demonstrate that 1.) Protèque lotion significantly reduces SLS-induced irritation when applied after SLS exposure, 2.) the antimicrobial additive triclosan is not the active ingredient modulating this effect, and 3.) treatment with Protèque lotion prior to UVB irradiation markedly reduces the severity of sunburn as assessed by multiple indices. (Supported by Protèque International, Inc.)

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