K SEBOLYTIC® SHAMPOO PROPERTIES: APPLICATIONS: • Antiseborrheic Cleansing shampoo as an aid for the control of keratoseborrheic disorders in dogs and cats • Keratolytic • Keratomodulating • Antibacterial • Antifungal What goes wrong in keratoseborrheic disorders (KSD)? S h a m p o o Staphylococcus intermedius HYPERSEBORRHEA Alteration in sebum and epidermal lipids secretion / composition Malassezia pachydermatis MICROBIAL PROLIFERATION KERATINIZATION DEFECTS Abnormal differentiation Epidermal barrier deficiency Excessive scale formation = Hyperkeratosis INFLAMMATION AND PRURITUS Basal cells hyperproliferation Inflammatory infiltrate Neutrophils 6/17 Lymphocytes Mastocytes MALODOR Sebolytic® response: a multi-site action TARGET ACTIONS Remove excess scale ACTIVE INGREDIENTS Salicylic acid Exfoliant action Keratoplastic effects on the intercellular cement (15) (15) Mildly bacteriostatic Linoleic acid Decrease horny layer thickness Help to control bacterial proliferation (15) Incorporation in the intercellular cement (16) Restore the epidermal barrier Maintain functional integrity of keratinocytes and promote their normal maturation ﻻlinolenic acid Major structural component of cell membrane phospholipids (17) Zinc gluconate Inhibits the enzyme 5α reductase which Reduce sebum secretion stimulates sebaceous secretion (18) 2. Regulate sebum production Vitamin B6 Piroctone olamine Synergistic inhibition of 5α reductase (18) Large antimicrobial spectrum (3, 4) (Gram + & Gram – bacteria, yeasts) High affinity for keratines 3. Control microbial proliferation Glycotechnologies 4. Reduction of skin inflammation Tea tree oil Reduce sebum secretion Antimicrobial activity High persistence on skin and hairs (3) Microbial anti-adhesive effect 5. Control malodor BENEFITS Solubilises intercellular cement 1. Correct keratinisation defects Regulate the keratinisation process PROPERTIES (5-9) Antimicrobial activity Natural sugars present in epidermal cell Respect the skin / microflora membranes (10) Reduction of cytokine signalling (11, 12) Immunomodulatory properties reduction of inflammation Natural pleasant odor Reduce malodor Interact with microbe membranes Reduction of histamine and inflammatory mediators production 7/17 (20) (21) Antimicrobial activity Reduction of skin inflammation and itching An optimised formula A formulation for optimal tolerance Mild cleansing agents Physiological pH. No coal tar, therefore : o No skin irritating, drying and staining effect o No unpleasant shampoo odor, appearance and color o Can be used in cats Tea Tree Oil provides a natural pleasant herbal scent, therefore no perfume was added to the shampoo, reducing hypersensitization hazards. Glycotechnologies complement the antimicrobial activity of piroctone olamine while respecting the cutaneous ecosystem A formulation for deep targeted action in skin To exert their inhibitory action on sebaceous gland secretion, topical zinc and vitamin B6 should penetrate and diffuse into deep skin structures. For this purpose they were incorporated, together with monosaccharides, in Non-ionic Spherulites®, that favour the flow of active ingredients to their sites of action. (22) Zinc gluconate Vitamin B6 Sebaceous glands Hair follicle Non-ionic Spherulites® delivering zinc gluconate and vitamin B6 in deep cutaneous structures What are the proofs of Sebolytic® efficacy and safety? Sebolytic® safety in cats Tolerance study to evaluate shampoo safety in cats (23) A number of reports have described signs of toxicity associated with the use of highly concentrated, low quality Tea Tree oil (Melaleuca oil) products in cats. However, an adapted much lower concentration (0.25%) of Melaleuca oil in the new Sebolytic shampoo, and the high quality of the raw material used, prevent the occurrence of similar hazards in cats. A specific study was performed to confirm the good local and general tolerance of the shampoo in this species. RESULTS: No significant change in animal body weight or food consumption was recorded over the study period. No local or general intolerance signs to the test shampoo were recorded. In particular, no skin irritation could be detected at any of the examination time points. 8/17 Sebolytic® clinical efficacy in dogs with KSD Randomized, double blind, multi-center field trial to evaluate clinical and antimicrobial efficacy of tar and non-tar antiseborrheic shampoos for dogs. (24) • • • • INCLUSION CRITERIA Dogs with severe/greasy KSD No pyoderma, parasitic disease, flea allergy dermatitis No treatment in the previous 3 weeks No concomitant treatment Sebolytic with tar 23 dogs 47 dogs 7 baths 3 day-intervals Day 1 B L I N D E V A L U A T I O N 1 2 Scales Skin greasiness Skin malodor Overall skin & haircoat condition Associated signs: pruritus, erythema, excoriations Product - smell - color - consistency - ease of use Cocci, Malassezia counts (oil immersion objective) MICROBIAL SCORE (0 to 4) 2 KSD Index reduction after 20 days of treatment 16 3 Scotch test & cytological exam at skin target sites: KSD INDEX (0 to 16) 1 USER SATISFACTION (0 to 4) Relative reduction of microbial score on treatment Day 1 Malassezia 14 12 Day 1 10 8 Day 20 4 22.2 Sebolytic with tar 4.2 Sebolytic without tar 2 100 Before treatment 16.7 Sebolytic with tar Day 20 Cocci 6 D20 24 dogs Sebolytic without tar 5.6 Sebolytic without tar 100 Before treatment 0 Sebolytic without tar 0 Sebolytic with tar 3 Product appreciation by users ODOR Very satisfied APPEARANCE & COLOR Satisfied Unsatisfied SEBOLYTIC WITHOUT TAR 0% SEBOLYTIC WITH TAR 20% SEBOLYTIC WITHOUT TAR 40% SEBOLYTIC WITH TAR 60% SEBOLYTIC WITHOUT TAR 80% SEBOLYTIC WITH TAR 100% GENERAL APPRECIATION Not satisfied at all 9/17 20 40 60 80 100 Sebolytic® without tar proved as effective as the reference tar shampoo, in controlling severe KSD signs and associated microbial proliferation in dogs. This new antiseborrheic shampoo represents a safe, better-accepted and efficient topical treatment alternative to coal-tar products in veterinary dermatology.
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