Experimental techniques: The Skin; Biocompatibility. Dr. Gábor Erős
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1 Experimental techniques: The Skin; Biocompatibility Dr. Gábor Erős
2 Structure of the skin
3 Possibilities - Human trials - Animal experiments - In vitro examinations
4 Cosmetic products and their ingredients must not be tested in animal experiments!!!
5 Questions and problems - Barrier function and transdermal drug delivery - Contact dermatitis: allergic or irritant - Rosacea - Sun damage, UV-radiation - Melanoma and other skin tumors - Wound healing
6 Methods - Inspection, palpation - Photography (photo analysis) - Non-invasive dermatophysiological methods - Ultrasound - Confocal laser scanning microscopy - Tape stripping + spectroscopy - Intravital videomicroscopy - Histology, immunhistochemistry
7 Animals used for dermatologic research - Large animals (pig) - Guinea pig, hamster, rabbit - Mouse There is a difference between HAIRLESS mouse and NUDE mouse NUDE: immun-compromitted HAIRLESS: mutant, but NOT immun-compromitted (SKH-1 and SKH-2)
8 Dermatophysiology: Transepidermal water loss (TEWL) - Diffusion principle in a opened chamber - Two pairs of sensors (temperature and relative humidity) inside the cavity - g / m 2 x h - dermatology, cosmetology, etc.
9 TEWL measurement in animal
10 Dermatophysiology: Melanin & Erythema (Mexameter) - 3 specific wavelengths - Reflection is measured, absorption is calculated - Special wavelength corresponding to the absorption peak of hemoglobin
11 Dermatophysiology: Skin Surface Hydratation (Corneometer) - Capacitance measurement of a dielectric medium - Temperature stability
12 Dermatophysiology: other parameters -ph - Sebum on the skin furface - Elasticity - Skin topography (UV-light video camera)
13 Ultrasound -Tumor - Burn injuries - Skin aging -Edema? - High frequency (15-70 MHz)
14 Confocal laser scanning microscopy - Depicts skin structures horizontally in cellular resolution Stratum corneum Stratum granulosum Papillary dermis
15 Tape stripping + spectroscopy - Adhesive tape to collect corneocytes - Analysis by means of Fourier transform infrared spectroscopy (FTIR) - Human trials, animal experiments (Csizmazia et al., Pharm Dev Technol 2010; Csizmazia et al., J Drug Del Sci Tech 2011)
16 Animal model of different skin disorders: Irritant contact dermatitis - Non-specific and non-imunological - External chemical or physical impacts - Inducible in rodents with different agents - Sodium lauryl sulphate (SLS), SDS - SLS: anionic surfactant
17 Other agents inducing skin irritation Chemical Methyl salicylate Phenol Croton oil Benzalkonium chloride Ethyl phenylpropiolate Maximal response 20 min 1 hr 6 hr 6 hr 8 hr (Patrick et al., Toxicol Appl Pharmacol 1985)
18 Irritant contact dermatitis: confocal microscopy images and routine H&E staining Disruption of stratum corneum Parakeratosis Microvesicle containing inflammatory cells Hicks et al., J Am Acad Dermatol; 2003
19 Animal model of different skin disorders: Allergic contact dermatitis - Mouse model: repeated application of 2,4,6-trinitro-1- chlorobenzene (TNCB) induces chronic allergic contact dermatitis (skin swelling + scratching behaviour) (days) Senzitization with TNCB (abdomen, epicutaneous) Challenge with TNCB (ears) (Yamaura et al., J Toxicol Sci 2011)
20 Animal model of different skin disorders: Wound healing (Sorg et al., J Anat 2007)
21 Animal model of different skin disorders: Transdermal drug delivery - Forming of a skinfold Buffer - Sandwiching of the skinfold with titanium frames Muscle Dermis Epidermis - Forming of a circular wound Gel - Fixation of the buffer-containing cylinder (Erős et al., Scientific World Journal (accepted for publication)
22
23 Animal model of different skin disorders: Melanoma - Large animal model: swine, horse (no sunlight etiology) - Goat (similar to that of caused by chronic sunlight exposure) - Guinea pig, hamster (dimethylbenzanthracene DMBA, metastases) In guinea pig: similarities to human - Mouse: VERY DIFFICULT! - DMBA + UV - Transgenic mice: HGF/SF (neonatally)
24 Biocompatibility 1. Biosafety - Appropriate host response (local and systemic) Biofunctionality - Ability to perform the special task - Absence of cytotoxicity, mutagenesis, carcinogenesis
25 Biocompatibility 2. Biomaterials and components relevant to in vivo assessment of tissue compatibility: - Additives, process contaminants, residues - Leachable substances - Degradation products - Other components in the final product - Properties and characteristics of the final product
26 Biocompatibility 3. Body contact and contact duration of implanted materials: - Surface devices - Skin - Mucosal membranes - Breached or compromised surfaces - External communicating devices - Blood (direct or indirect) -Tissue / bone /dentin Contact duration: - Limited ( 24 h) - Prolonged (>24 h and <30 days) - Permanent (>30 days) (FDA-categories)
27 Biocompatibility 4. Biological response tests: (prior to clinical testing) - Cytotoxicity - Sensitization - Irritation - Intracutaneous reactivity - Systemic toxicity (acute) - Subchronic toxicity - Genotoxicity - Implantation - Hemocompatibility INITIAL EVALUATION STEPS - Chronic toxicity - Carcinogenicity - Reproductive and developmental toxicity - Biodegradation SUPPLEMENTARY EVALUATION STEPS
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