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  2. 2. A cosmeceutical is an ingredient with medicinal properties, which manifests beneficial topical actions and provides protection against degenerative skin conditions The term cosmeceutical was coined in 1980 by the dermatologist Albert kligman
  3. 3. The FD&C Act does not recognize any such category as "cosmeceuticals.“  A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.
  4. 4. According to FD&C Act. COSMETICS “Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" DRUG "Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals
  5. 5. International Regulatory Policies Cosmetics No extensive testing like drugs Less time consuming and cost Prohibit the false advertisements. Cosmeceuticals Cosmecuticals are not regulated by the U.S.FDA are not subject to premarket requirements for proof of safety or efficacy. Cosmecuticals products in vitro studies using silicone replicas of skin clinical trials (supported by the cosmetic companies themselves) The rigorous testing required for pharmaceuticals, is not mandatory for cosmeceuticals products
  6. 6. Cosmetic versus drug A deodorant is a cosmetic but an antiperspirant is a drug A shampoo is a cosmetic but an antidandruff shampoo is a drug A toothpaste is a cosmetic but an anticaries toothpaste is drug A mouthwash is cosmetic but an antigingivitis mouth wash is a drug A suntan product is a cosmetic but a sunscreen product is a drug A skin moisturizer is a cosmetic but a wrinkle remover is a drug A skin product to hide acne is cosmetic but an antiacne product is a drug An antibacterial deodorant soap is a cosmetic but an antibacterial antiinfective soap is a drug
  7. 7. List of common ingredient used in cosmeceuticals •UV protection •Exfoliants •Alpha hydroxy acids Lactic acid Glycolic acid •Beta hydroxy acids •Retinoids •Moisturizers •Antioxidants •Peptides •De-pigmenting agents
  8. 8. Uv protection UVA wavelengths penetrate deeply into the dermis, causing skin to wrinkle. UVB radiation is associated with many skin cancers. The SPF number on sun blockers only applies to UVB protection and has no connection with UVA protection. A SPF number of 30 is recommended for daily use. Higher numbers do not proportionately increase protection. Exfoliants Exfoliants remove dead cells and the outer layers of thickened skin, encouraging skin turnover. Alpha hydroxy acids Softens fine wrinkles, lightens pigmentation spots, generally tightens and improves skin texture. Makes skin look healthier and more radiant.
  9. 9. Retinoids Treats mild to moderate acne and photo-damaged skin, removes dead surface cells, Claims to build collagen, regenerate the skin’s elasticity. Moisturizers Moisturizers smooth the surface of the skin, lubricate its outer layers, and lock in moisture. Antioxidants Antioxidants, the ingredients meant to defend against free radical damage. Vitamin A & C Resveratrol Green tea Co-enzyme Q-10 Algae
  10. 10. Peptides peptides that may stimulate skin metabolism and repair, while others may inhibit hyperpigmentation, slow the breakdown of collagen Eg: Argireline Depigmentation agents It acts by inhibiting conversion of tyrosine to melanin Eg: Hydroquinone, aloesin, arbutin, azelaic acid, glycolic acid
  11. 11. Why Does Skin Age?? Aging results from cumulative damage to tissues that overwhelm the body's natural ability to repair them. The tell tale signs of aging on the skin include discoloration, wrinkles, and texture loss These effects result from •Genetically programmed chronological aging •Photoaging - sun exposure •Environmental and lifestyle factors – damage by chemicals, pollutants, smoking, etc.
  12. 12. What are Sunscreens? Certain synthetic organic substances or sunscreens have molecular structures that are capable of "filtering out" the harmful UV rays by mechanisms including absorption, reflection or diffusion. Examples include avobenzone, aminobenzoic acid, titanium oxide, zinc oxide and others. Such ingredients appear in the FDA monograph on sunscreen agents. Sunscreens are regulated as over the counter drugs by the FDA. The efficacy of sunscreens is measured as SPF (sun protection factor).
  13. 13. Photoaging - sun exposure Effect of UV Rays UV damage is manifested as • sunburn, • skin discoloration •texture loss. UV rays also trigger skin aging through: Free radical reactions and oxidative stress. Increased activity of enzymes such as collagenase and elastase that are catalyzed by metal ions.
  14. 14. The results are:    Abnormal cross linking of Collagen fibers Scar tissue build up and visible wrinkles and skin discoloration Ravages of chronological aging are accelerated
  15. 15. The sunscreens listed in the FDA OTC monograph Drug Name Concentration % Absorbance Aminobenzoic acid up to 15 UVB Avobenzone 2-3 UVA I Cinoxate up to 3 UVB Dioxybenzone II up to 3 UVB, UVA I & II Homosalate up to 15 UVB Menthyl anthranilate up to 5 UVA II Octyl methoxycinnamate up to 7.5 UVB Octisalate up to 5 UVB Oxybenzone up to 5 UVB Padimate O up to 8 UVB Phenylbenzimidazole sulfonic acid up to 4 UVB Sulisobenzone up to 10 UVB, UVA II Titanium dioxide 2-25 Physical Trolamine salicylate up to 12 UVB Zinc oxide 2-20 Physical
  16. 16. Several natural extracts protect the skin from the damaging effects of UV rays: •Tetrahydrocurcuminoids •SabiWhite •Green tea Extract •Sesame antioxidants •Umbelliferin •Xylosin •Rosemary extract •Rosmarinic acid •Lupeol •Arjunolic acid
  17. 17. Product Safety Testing Testing needs are determined by the company marketing the product .May include: •In vitro testing •Cumulative Irritation testing •Repeat Insult Patch Tests (RIPT) •Sensitization •Ocular Irritation •Facial Sting •Phototoxicity •Photoallergy •Dermal irritation •Acnegenicity
  18. 18. Dermal irritation Defined as the production of “reversible damage of the skin following the application of a test substance for up to 4 hours”. Tests used to study dermal irritation: 1. EPISKIN™ human skin model. 2. EpiDerm™ human skin model. 3. PREDISKIN™ human skin model. 4. Pig ear test.
  19. 19. Examples of Instrumental Measurements Parameter Instrument Moisturization Conductance/Impedance Skin barrier function TEWL(Transepidermal Water Loss) Skin texture Topography Skin elasticity Elastometer Skin thickness Ultrasound Blood flow Laser Doppler Sebum (oiliness) Sebumeter Color Chromameter
  20. 20. Advantage of cosmeceuticals •Safe for long-terms use •Promote beauty throught health and wellness of skin •cosmeceuticals with natural ingredients are preferred.
  21. 21. REFERENCE 1) Kligman AM. Cosmetics A dermatologists look to the future: Promises and problems. Dermatol Clin 2000; 18:699-709. 2) Food & Drug Administration (FDA) 3) Cosmetic, Toiletry, and Fragrance Association (CTFA) 4) Thornfeldt C. Cosmeceuticals containing herbs: fact, fiction, and future. Dermatol Surg. Jul 2005;31(7 Pt 2):873‐80; 5) Amer.M, Maged M. Cosmeceuticals versus pharmaceuticals. Clinics in Dermatology 2009; 27:428–430.