Scientific investigation and veterinary information

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1 Scientific investigation and veterinary information Abstract Efficacy study on the moisturising spray Ermidrà versus placebo in restoring skin barrier function in a model of damaged skin barrier in the dog Pin D. Dr. Med. Vet, Vidémont E. Dr. Med. Vet., Ghibaudo G. Dr. Med. Vet.. Reserved to Veterinarians and Pharmacists

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3 Scientific investigation and veterinary information Abstract Efficacy study on the moisturising spray Ermidrà versus placebo in restoring skin barrier function in a model of damaged skin barrier in the dog Pin D. Dr. Med. Vet., Vidémont E. Dr. Med. Vet., Ghibaudo G. Dr. Med. Vet.. Moisturising spray for the skin and fur of cats and dogs. Composition Cyclodextrins: stabilising and emulsifying agents. D-panthenol: active ingredient derived from pantothenic acid with elasticising properties. Supports the physiological level of skin moisturisation and strengthens hair structure. Improves the structure of fur and prevents its dehydration. Liposomes: microspheres that penetrate into the deepest epidermal layers, gradually releasing moisturising active ingredients. Zinc gluconate: decisive for maintaining the physiological balance of the skin barrier by regularising its turnover. Willow-Herb (epilobium angustifolium): the extract of this plant, which is rich in astringent tannins, allows to regulate sebum production. It also has soothing and softening properties. Propylene glycol: high moisturising and keratolytic action. Glycerine: re-moisturising and softening action. Indications With its unique and innovative formula, Ermidrà spray is the ideal product to correctly moisturise the fur and skin of cats and dogs. Hence, it can be used after every type of shampoo to restructure the cutaneous hydrolipidic film. Moreover, with its innovative composition, this spray provides effective topical support in the following cases: dry or oily seborrhoea; when the skin reactivity threshold is exceeded; very high environmental temperature in summer, for instance, or in winter experienced by pets living in either closed or heated environments. Instructions for use Shake well before use. Apply Ermidrà spray on the pet's entire coat, ensuring that the product comes in contact with the skin. For long-haired pets or those with a thick coat of fur, spray backwards. Do not rinse. Do not dry. Apply Ermidrà spray once or twice a day, as indicated by the Vet. Bottle 300 ml Moisturising spray for the skin and fur of cats and dogs.

4 Photos by Dr. Giovanni Ghibaudo 1. The «tape stripping» method consists of applying adhesive tape on a previously established skin area. This procedure allows to remove the various layers of the horny skin in order to damage the skin barrier. The study on restoring the skin barrier entails measuring transepidermal water loss and performing a histopathological examination of skin biopsies collected from the areas focused on by the study. A hemalum-eosin stain and immuno-marking were performed during the histopathological examination to observe the evolution of cell proliferation and epidermal differentiation proteins. A study yet to be published, conducted by Prof. Didier Pin from the University of Veterinary Medicine, Lyon (France), was presented as an open communication at the European Congress of Veterinary Dermatology, Brussels, 2011: Efficacy study on the moisturising spray Ermidrà versus placebo in restoring skin barrier function in a model of damaged skin barrier in the dog. Scope of the study The scope of the study conducted by the Dermatology Unit of VetAgro Sup Campus Vétérinaire, Lyon, was to assess the efficacy of Ermidrà spray in a model of chronic skin barrier damage in the dog. To prove the efficacy of Ermidrà moisturising spray in case of an altered skin barrier, the study compared the effect of the application of Ermidrà spray with that of a NaCl solution. This model of chronic skin barrier damage consists of «stripping» the same site for several days to obtain skin lichenification and transepidermal water loss (TEWL) of about 100 g/m2/h that was measured with a device, the VapoMeter (Delfin Technologies Ltd). Results All microscopic lesions indicating the chronic nature of the epidermal barrier damage (compact horny layer, epidermal acanthosis, basal and suprabasal cell layer proliferation sites, and presence of epidermal crests, inflammatory infiltrates available either in the perivascular region or generally disseminated), particularly in the horny layer, disappeared or clearly diminished in the treated sites in 07 days with twice daily application of Ermidrà, while they were either persistent or presented a moderate improvement in control sites with twice daily application of physiological solution.

5 Abstract Evolution of mean TEWL values of all test sites and all sites treated with Ermidrà, in 06 dogs (36 control sites and 36 sites with Ermidrà ) during the first 08 hours of the study mean of control sites mean of sites treated with Ermidrà Linear (mean of control sites) Linear (mean of sites treated with Ermidrà ) Time (in hours), T0 = start of application of Ermidrà, soon after using adhesive tape Different inclination of the two solid line curves (controls and treated) between T0 and T0+2 Controls curve (blue with solid line): inclination= Treated subjects curve (red with solid line): inclination= The difference is more remarkable considering that TEWL values at T0 are higher for treated sites than for control sites. The same phenomenon is confirmed by the trend lines (broken lines, blue for controls, red for treated subjects), where the two curves move in the two opposite directions (upward for controls, downward for treated subjects), crossing each other. The treated subjects curve (solid red line) shows a rapid reduction in TEWL during the first two hours, following stabilisation. The controls curve (solid blue line) shows a less defined reduction during the first two hours, followed by a considerable upward spike at T0+8. This spike is generally observed in the healthy dog.it corresponds to the fact that, after the skin barrier is damaged by the repeated application of adhesive tape, lipids present in the epidermis are rapidly mobilised to compensate for said damage, which can be noticed by the diminishing TEWL. When cell reserves of lipids are depleted, compensation stops and TEWL increases until new lipids are synthesised and return to repair the skin barrier lesion. The application of Ermidrà prevents the spike, namely the increase in TEWL, by compensating for the skin barrier damage (even without cell lipids) with a remoisturising action that justifies its use.

6 Graph 02: evolution during the 144 hours of the study Evolution of the mean of TEWL values of all control sites and of all sites treated with Ermidrà in 06 dogs (36 control sites and 36 sites with Ermidrà ) during the overall duration of the study mean of control sites mean of sites treated with Ermidrà Linear (mean of control sites) Linear (mean of sites treated with Ermidrà ) Time (in hours), T0 = start of application of Ermidrà, soon after using adhesive tape The curves of both controls and treated subjects present the same evolution, precisely a slow descent in time. However, TEWL values, both for treated sites and during every assessment in time, are lower than those obtained for control sites (the solid red line is always lower than the solid blue line). The inclination of the trend curve of treated sites (red broken line) is higher than the inclination of the trend curve of control sites (blue broken line). At 144 hours a return to baseline levels of TEWL can be observed for treated sites, while the value is higher for control sites.

7 References Beco L, Fontaine J. Cornéométrie et perte d eau transépidermique : validation des techniques chez des chiens sains. Ann Méd Vét 2000 ; 144 : Breternitz M, Flach M, Präbler J, Elsner P, Fluhr JW. Acute barrier disruption by adhesive tapes is influenced by pressure, time and anatomical location: integrity and cohesion assessed by sequential tape stripping; a randomized, controlled study. Br J dermatol 2007; 156: Denda M, Wood LC, Emani S, Calhoun C, Brown BE, Elias PM, Feingold KR. The epidermal hyperplasia associated with repeated barrier disruption by acetone treatment or tape stripping cannot be attributed to increased water loss. Arch Dermatol Res 1996; 288: Fluhr JW, Feingold KR, Elias PM. Transepidermal water loss reflects permeability barrier status: validation in human and rodent in vivo and ex vivo models. Exp Dermatol 2006; 15: Hachem JP, Crumrine D, Fluhr J, Brown BE, Feinglod KR, Elias PM. ph regulates epidermal permeability barrier homeostasis, and stratum corneum integrity/cohesion. J Invest Dermatol 2003; 121: Hachem JP, Houben E, Crumrine D et al. Serine protease signaling of epidermal permeability barrier homeostasis. J Invest Dermatol 2006; 126: Hester SL, Rees CA, Kennis RA, Zoran DL, Bigley KE, Wright AS, Kirby NA, Bauer JE. Evaluation of corneometry (skin hydration) and transepidermal water-loss measurements in two canine breeds. J Nutr 2004; 134: 2110S-3S.

8 mentalism sas DPE0063/01