HEALTH AND PERSONAL CARE

Transcription

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2 1. INTRODUCTION 1.1 Acne facts 1.2 What cause acne? 1.3 Types of acne 1.4 Treatment 2. BERACARE TRIPLE A SYSTEM: CONCEPT 3. BERACARE TRIPLE A SYSTEM: in vivo effectiveness 3.1 Assessment of its effect on acne lesions (comedos) 3.2 Assessment of the antiseborrheic activity 3.3 Evaluation of the cosmetic effectiveness 4. BERACARE TRIPLE A SYSTEM: action against Propionibacterium acnes (Minimum Inhibitory Concentration) 5. BERACARE TRIPLE A SYSTEM: general conclusions 6. TOXICOLOGICAL DATA: dermatological evaluation topical compatibility 6.1 Patch test: skin tolerance 6.2 Conclusions 7. TOXICOLOGICAL DATA: dermatological evaluation of potential photoirritant and photosensitization topic 7.1 Patch test: photoirritation and photosensitization 7.2 Conclusions 8. BERACARE TRIPLE A SYSTEM: Cosmetic interest 9. BERACARE TRIPLE A SYSTEM: General conclusions 10. BERACARE TRIPLE A SYSTEM: Technical specifications 11. BERACARE TRIPLE A SYSTEM: Storage information 12. BERACARE TRIPLE A SYSTEM: Regulatory information 13. REFERENCES

3 1. INTRODUCTION 1.1 ACNE FACTS Acne is a disease of the pilosebaceous duct (hair follicle). The characteristic lesion is the comedo a collection of sebaceous secretions and dead cells retained in the hair follicle and excretory duct of the sebaceous gland. Non-inflammatory comedomes are commonly called pimples and can be opened (blackheads) or closed (whiteheads). If bacteria are present, then the secretion of lipases (enzymes) can break down the oily sebaceous materials. The release of free fatty acids results in an inflammatory response causing erythema (redness) and swelling around the comedones. If the comedos are ruptured, inflammation is spread and inflammatory acne cab result in the skin becoming elevated (papule), filled with pus (pustules) or the formation of cysts. Over 90% of the population suffer from pimples and acne at some time of their life. Although more frequently associated with hormonal changes during teenage years, it can persist well into the twenties and sometimes much more later in life. o Blackhead Whitehead

4 Acne pathogeny Follicle and precocious comedo Papule / Pustule

5 Whitehead (closed) / Blackhead (opened) Nodule / Scar 1.2 WHAT CAUSE ACNE? There are three main causes of acne and generally all three need to be present. - Oily skin: sebaceous secretions typically increase during puberty and stages in the menstrual cycle as a result of increase androgen production. - Bacterial infection: particularly by the anaerobic Propionibacterium acnes. - Hyperkeratosis of the follicular wall leading to a thickening of the hair follicle wall and closing of the orifice. 1.3 TYPES OF ACNE Acne vulgaris is the most common form of acne which includes several types of pimples. These acne lesions include blackheads, whiteheads, papules, pustules, nodules and cysts. Mild to moderate acne vulgaris consists of the following types of acne spots: - Blackheads: result when a pore is only partially blocked, allowing some of trapped sebum, bacteria, and dead skin cells to slowly drain to the surface. The black color is not caused by dirt. Rather, it is a reaction of the skin s own pigment, melanin, reacting with the oxygen in the air. A blackhead tends to be a stable structure, and can often take a long time to clear. - Whiteheads: result when a pore is completely blocked, trapping sebum, bacteria, and dead skin cells, causing a white appearance on the surface. These types of acne lesions sometimes seem to be begging to be popped and are normally quicker on life cycle than blackheads.

6 - Papules: are small, normally red, tender bumps with no head. Do not squeeze a papule. It will do no good, and may exacerbate scarring. - Pustules: is similar to whiteheads, but is inflamed, and appears as a red circle with a white or yellow center. Severe acne vulgaris is characterized by nodules and cysts: - Nodules: As opposed to the lesions mentioned above, nodular acne consists of acne spots which are much larger, can be quite painful, and can sometimes last for months. Nodules are large, hard bumps under the skin s surface. Scarring is common and absolutely do not attempt to squeeze such a lesion. You may cause severe trauma to the skin and the lesion may last for months longer than it normally would. - Cysts: an acne cyst can appear similar to a nodule, but is pus-filled, and can been described as having a diameter of 5mm or more across. They can be painful. Again, scarring is common with cystic acne. Squeezing an acne cyst may cause a deeper infection and more painful inflammation which will last much longer than if you had left it alone. Acne type I Acne type II Acne type III Acne type IV

7 1.4 TREATMENT Acne treatment consists of reducing sebum production; remove dead skin cells (squamation) and killing bacteria with topical drugs or actives and oral medications. The treatment depends upon whether the acne is mild, moderate or severe. Normally the treatment of acne consists in reducing the formation of new comedones and it is common use topical of: tretinoin, benzoyl peroxide, adapalene, or salicylic acid. Topical medications are avaiable as cream, gel, lotion, pads or tonics preparations and normally include: - Antibiotics (agents that kill bacteria): such as erythromycin, clindamycin and meclocycline - Comedolitytics (agents that loosen hard plugs and open pores): such as vitamin A acid tretinoin, salicylic acid, adapalene, resorcinol and sulfur. - Comedolitycs and antibiotics: such as benzoyl peroxide, azelaic acid, or benzoyl peroxide plus erythromycin are used. It is common to find topical products with this actives but is common to have adverse effects with these actives, for example: - Benzoyl peroxide: promotes contact allergy and local irritation - Erythromycin: promotes irritation, redness and pruritis - Salicylic acid: local irritation, redness Sometimes it is possible observe an adverse effects such as peeling (desquamation), irritation, dryness, and increased sensitive to sunlight and is required use of a sunscreen. In some case there are difficulties in manipulate the active mainly treating about the solubilization of the active, because the most of these actives are in powder form. After studies BERACA INGREDIENTES developed a great product with natural actives that acts treating the acne without adverse effects.

8 2. BERACARE TRIPLE A SYSTEM: CONCEPT BERACARE TRIPLE A SYSTEM was developed to improve the healthy of acne prone skin. The effectiveness of this product is obtained because of the synergism between different natural constituents. These constituents were extracted from natural products from RAIN FOREST and were choose because there are special properties in each one, and togheter form a multifunctional active. 1-) Flavonoids (anthocyanins) obtained from Euterpe oleracea The anthocyanins or flavonoids are powerful natural antioxidants that provide some protection against environmental damage to the skin and are effective in slowing down skin inflammation because provide the action against free radical during inflammatory process. In synergism with fatty acid and phytosterols promotes skin benefits like, miniaturization and regeneration. 2-) Terpens and essential fatty acid obtained from Carapa guaianensis seed oil Normally the deficiency in fatty acids causes the epidermis to thicken due to cell proliferation, and increase in trans epidermic water loss (TEWL) too. The fatty acid obtained from Carapa guaianensis promotes regeneration of the epidermis maintaining the natural moisture of the skin. The anti-inflammatory action and calm effect is promoted because of the terpenic components LIMMONOIDS contained in the unsaponifiable matter. These substances contained in the oil are mostly limmonoids, degraded triterpenes which have shown to be biologically active as anti-inflammatory agents. 3-) Beta- caryophyllene obtained from Copaifera officinalis (copaiba balsam) resin Beta-caryophyllene (sesquiterpene) is a natural germicide obtained of the essential oil (obtained of the part of balsam by distillation), excellent for preventing infections and inflammations.

9 3. IN VIVO EFFECTIVENESS OF BERACARE TRIPLE A SYSTEM WITH OILY AND ACNE PRONE SKINS The effectiveness of BERACARE TRIPLE A SYSTEM has been demonstrated at level of 1,5% on volunteers, and it was observed after treatment of 56 days (approximately 8 weeks). These volunteers had oily and acne prone skin. Study principle - assessment of its effect on acne type lesions (comedos); - assessment of the antiseborrheic effect - assessment of the effectiveness and the tolerance of the active ingredient and formulation too, by volunteers Formulation studied BERACARE TRIPLE A SYSTEM has been tested at level of 1,5% in a cosmetic formulation (basic formulation). The formulation it was tested with ingredients non comedogenic and neutrals.

10 Formulation studied Formulation Code: ANTI ACNE FACIAL CREAM FAC02103G05 INGREDIENTS INCI NAME % W/W SUPPLIER PHASE A Desmineralized water Water 80,10 - VERSENE POWDER Tetrasodium EDTA 0,10 DOW CHEMICALS BERACARE LPFF Phospholipids (and) Silica (and) Maltodextrin 0,50 BERACA INGREDIENTS METHYLPARABEN Methylparaben 0,10 - GERMAL 115 Imidazolydinyl Urea 0,20 ISP BERACARE TRIPLE A SYSTEM PHASE B Copaifera officinalis (balsam copaiba) resin, carapa guaianensis seed oil, euterpe oleracea fruit oil 1,50 BERACA INGREDIENTS CETEARYL ALCOHOL Cetearyl Alcohol 4,00 - BERACARE APS Steareth 2 (and) Steareth 2 (and) PPG 15 Stearyl Ether 2,00 BERACA INGREDIENTS OCTYL PALMITATE Octyl Palmitate 2,00 - BERAOIL V0900 Helianthus Annus (Sunflower) Seed Oil 1,00 BERACA INGREDIENTS PROPYLPARABEN Propylparaben 0,10 - Procedure: PHASE C FRAGRANCE Fragrance 0,50 - ü Heat phase A to 80 C (after disperse BERACARE LPFF until total homogenezation); ü Heat phase B to 80 C separately; ü Add phase A to B and homogenize during 10 minutes stirring and keep the temperature until total homogenezation. ü Cool down to 40 C and add phase C whilst stirring moderately. ü Cool further down to R.T. whilst stirring.

11 3.1 Assessment of its effect on acne type lesions (comedos) Study protocol I - Evaluation of activity in retention and inflammatory lesions, before and after treatment; - 20 adult volunteers of both sex had been selected with oily or mixing acne prone skin - The number of retentional elements (comedos, cysts...) was counted on the face of the volunteers on the first day (Day 0) - The volunteers treated the area (the right side of face) applying the formulation with 1,5% of BERACARE TRIPLE A SYSTEM twice a day for 8 weeks (56 days) Results obtained: COMEDOLYTIC ACTIVITY D0 100% D28-30% D56-72% 0% 20% 40% 60% 80% 100% 120% Percentage of Comedos Inhibition Comedolytic activity: % of comedos inhibition: 30% after 4 weeks (D28) 72% after 8 weeks (D56)

12 3.2 Assessment of the anti-seborrheic activity Study protocol II - 10 adult volunteers of both sexes had been selected - It was measured the rate of superficial skin lipids using a SEBUMETER on the skin of the volunteers, on the forehead. - The forehead was divided with a line in two sides - The right side of the forehead was used as control area where no application was carried out - The left side of the forehead is the area treated with de cream with 1,5% of BERACARE TRIPLE A SYSTEM twice day during 6 weeks (42 days) Results obtained: EVOLUTION OF "SEBUM" QUANTITY D0 D42-65% micro grams/cm2 After 6 weeks (42 days) it was concluded that BERACARE TRIPLE A SYSTEM reduced in approximately 65% the evolution of SEBUM quantity. 3.3 Assessment of the effectiveness and the tolerance of the active ingredient and formulation too, by volunteers

13 Study protocol III - The same volunteers who had participated of the dermatological panel had made the cosmetic evaluation of the product - The points evaluated were: adstringent effect, moisturizer effect, less oily skin, matt effect, cleanser skin. Cosmetic effectiveness: Auto-evaluation % of panel 100% 95% 90% 85% 85% 90% 95% 95% 90% 80% Adstringent effect Moisturization Less oily Control "matt" effect Cleanness

14 4. BERACARE TRIPLE A SYSTEM: Action against Propionibacterium acnes (Minimum Inhibitory Concentration) Propionibacterium acnes is most frequently found in people with acne prone skin (quantitatively is found in polysebaceous follicle). This bacteria produce lipases that is able to break down sebum triglycerides into free fatty acids (known for being comedogenic), so start the process of hyperkeratinization of the follicle, leading to the formation of comedos. It was evaluated the MIC (Minimum Inhibitory Concnetration) of BERACARE TRIPLE A SYSTEM against Propioniumbacterium acnes. Methodology: INCQS ( rev.01) Fundação Oswaldo Cruz. Manual da Qualidade. Método da verificação da Capacidade Inibitória de cosméticos, medicamentos não estéreis, matérias-primas e correlatos FARMACOPÉIA BRASILEIRA. 4ed. São Paulo: Atheneu,1988 Result: It was observed that BERACARE TRIPLE A SYSTEM has bactericidal action, and may not permit its own contamination by the microorganism evaluated. It was concluded that BERACARE TRIPLE A SYSTEM presents efficient bactericidal action with strains of Propionibacterium acnes (ATCC 6919) when used at 1,5% of concentration. The control treatment presented satisfactory results and validate performance essay.

15 5. BERACARE TRIPLE A SYSTEM: General conclusions After 8 weeks BERACARE TRIPLE A SYSTEM reduces the number of comedos effectively in 72%. After 6 weeks BERACARE TRIPLE A SYSTEM regulates sebum activity reducing effectively 70% approximately. After 8 weeks of use it was possible to prove by the volunteers that the skin becomes less oily more matt, cleaner and softer and moisturizer. 6. TOXICOLOGICAL DATA: Dermatological evaluation topical compatibility 6.1 PATCH TEST: SKIN TOLERANCE Objective: To prove the absence of primary irritation, accumulated irritation and accumulated sensitization potential of the formulation for topical use of the BERACARE TRIPLE A SYSTEM. 6.2 CONCLUSIONS The products cited before was evaluated under the following compatibility cutaneous clinical study: ü Primary skin irritation ü Cumulative skin irritation ü Skin sensitization Under the conditions that BERACARE TRIPLE A SYSTEM was evaluated and in the sample of volunteers studied, the data allows us to concluded that: There were no irritation potential observed There were no sensitization potential observed

16 7. TOXICOLOGICAL DATA: Dermatological evaluation of potential photo-irritant and photosensitization topic 7.1 PATCH TEST: Photoirritation and photosensitization Objective: To prove the absence of photo-irritation potential and photosensitization potential of the formulation for topical use of the BERACARE TRIPLE A SYSTEM. 7.2 CONCLUSIONS BERACARE TRIPLE A SYSTEM was evaluated under the following compatibility cutaneous clinical study protocols: ü Photo-irritation primary and cumulative ü Photosensitization Under the conditions that all the products from BERACARE TRIPLE SYSTEM was evaluated and in the sample of volunteers studied, the data allows us to concluded that: There were no photo-irritation potential observed There were no photosensitization (photoallergy) potential observed

17 8. COSMETIC INTEREST 8.1 APPLICATIONS HEALTH AND PERSONAL CARE According to the comedolytic and antiseborrheic activity BERACARE TRIPLE A SYSTEM is a natural active that can be applied in cosmetic formulations with special concentration, from 1,5% mainly in products for the treatment of oily and mixed oily skin, and acne prone skin. According to toxicological data BERACARE TRIPLE A SYSTEM is: ü non-comedogenic (can be applied in hyppoalergenic products). Is a product easy to manipulate and can be applied in formulations like: - Sprayable emulsions - creams (W/O and O/W) - lotions (W/O and O/W) - milks (W/O and O/W) - serums - wipes - tonics (adstringent effect, cleansing effect,...) - gels - foaming products (liquid soap, syndet, shower gel, cleansing foaming,...) - make-up 9. GENERAL CONCLUSION BERACARE TRIPLE A SYSTEM is: 100% natural Isn t irritating and sensitizing to skin (non-comedogenic) Isn t necessary to use sunscreen together (we only indicated use sunscreen such a complete to protect the skin against UV rays. It is easy to manipulate, due to solubility in many cosmetic ingredients is possible apply in: liquid soaps, soap, tonics, wipes, emulsion (O/W and W/O), make-up

18 10. TECHNICAL SPECIFICATIONS ANALYSIS UNITS SPECIFICATION Appearance Visual Liquid Color Visual Yellow to greenish Color (Lovibond) % (R/Y/B/N) < 1,0R / < 20,0Y / < 1,0B / < 1,0N Cor (Gardner) % < 15,0 Specific gravity g/cm 3 0,885 0,935 Refractive index - 1,478 1,498 Acidity value % oleic acid < 5,0 Total microbiologic count cfu/g <100 SOLUBILITY Propylene glycol Alcohol Glycerin Vegetable oil Mineral oil PPG-15 Stearyl ether PPG-2 Hydroxyethyl cocamide PPG-2 Hydroxyethyl stearamide Octyl palmitate Caprylic / Capric Triglyceride Isopropyl palmitate Bechidroils Insoluble Insoluble Insoluble Soluble Soluble Soluble Soluble Soluble Soluble Soluble Soluble Soluble 11. STORAGE INFORMATION BERACARE TRIPLE A SYSTEM is stable until 18 months when stored in cool, dry, and well ventilated surroundings. Light protected, not above room temperature, in original and tightly sealed containers (nitrogen blanketed).

19 12. REGULATORY INFORMATION ü INCI name CTFA / CAS number ü INCI name EU Labeling / CAS number INCI name (CTFA) CAS no. Copaifera officinalis (balsam copaiba) resin Carapa guaianensis seed oil Euterpe oleracea fruit oil INCI name (EU LABELING) CAS no. Copaifera officinalis oil Carapa guaianensis nut oil Euterpe oleracea oil REFERENCES - Viglioglia y Rubin Cosmiatria II. 2 ª edition, Peyrefitte, G.; Martini, M.C.; Chivot, M. Cahiers D Esthétique Cosmétique. Andrei, National Health Council: Resolution 196/96 of the Ministry of Health. Official diary, Oct.16, Sampaio e Col. Dermatology. Fourthy edition, Medicals Arts, Basketter, reynolds & York: Predicitive testing in Contact Dermatitis: Irritant Dermatitis. Elsevier Science Inc, Kligman, A.M.; Wooding, W.M. A method for the measurement and Evaluation of Irritants of Human Skin. J. Invest Dermatol. 49:78-94, Maibach, H.I.; Epstein, W.L. Predicitive Patch testing for Sensitization and irritation. Am. Perf. And Cosm.80: Maibach, H.I.; Marzulli, F.N. Dermatotoxicology. Fifth Edition. Taylor and Francis Publishers, Jackson, E.M.; Goldner, R. irritant Contact Dermatitis. Marcel Dekker, INC, Walker, A.P.; Basketter, D.A.; Baverel, M. e col. Test Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients in Man. Food and Chemical Toxicology. 35: , 1997.

20 - Rietschel R.L, Towler, J.F.J. Fisher s Contact Dermatitis. Fifth Edition. Lizriwot Williams & Williams. - Cosmetics & Toiletries magazine. Vol.119, no. 3/March Basile A.C.; Sertié J.Á.; Freitas P.C.; Zanini A.C. J Ethnopharmacol, 22:1, 1988Jan, HAMMER et al Journal of Ethnopharmacology, 40: ; P. - GRENARD et al Pharmacopés Tradicionalles en Guyane, Orstom, Paris, pp