RESEARCH PROTOCOL                                                                                        1 of 8Revision 04...
RESEARCH PROTOCOL                                                                                  2 of 8Revision 041. INT...
RESEARCH PROTOCOL                                                                                    3 of 8Revision 04    ...
RESEARCH PROTOCOL                                                                                     4 of 8Revision 043. ...
RESEARCH PROTOCOL                                                                                     5 of 8Revision 043.5...
RESEARCH PROTOCOL                                                                                     6 of 8Revision 043.6...
RESEARCH PROTOCOL                                                                                   7 of 8Revision 044. RE...
RESEARCH PROTOCOL                                                                                 8 of 8   Revision 04    ...
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Assessment of the cumulative irritation and sensitization ript


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Assessment of the cumulative irritation and sensitization ript

  1. 1. RESEARCH PROTOCOL 1 of 8Revision 04 Allergisa pesquisa dermato-cosmética ltda. ASSESSMENT OF THE CUMULATIVE IRRITATION AND SENSITIZATION POTENTIALS (Repeated Insult Patch Test) RESEARCH PROTOCOLCONTENTS 1. Introduction 2 of 8 2. Objective 3 of 8 3. Methods 4 of 8 3.1. Population and Sample 4 of 8 3.2. Ethical Aspects 4 of 8 3.3. Product 4 of 8 3.4. Required Material and Equipments 4 of 8 3.5. Study Length 5 of 8 3.6. Methodology 5 of 8 3.7. Study Design 6 of 8 3.8. Results 6 of 8 4. References 7 of 8 History of Revision 8 of 8ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT
  2. 2. RESEARCH PROTOCOL 2 of 8Revision 041. INTRODUCTION Over the last few years, the cosmetic and pharmaceutical industry has grownconsiderably, same as its concern in developing effective and safe products. Thecreation of the Consumer Defense Code, the requirements of the National Agency ofSanitary Surveillance of the Ministry of Health and the competition itself have led thecompanies to adopt a more careful attitude as to the action and benefits of their productsby trying to associate their claims to scientific works. Industry awareness and consumer requirements caused cosmetic manufacturers toadopt a new procedure: before marketing a product, nowadays companies areconcerned to conduct clinical tests on safety and efficacy, which are coordinated bydermatologists. This procedure provides cosmetic companies with greater safety,credibility and reliability from their consumers. A growing concern of the cosmetic industry is the prevention of possible adversereactions in users of its products. After all, consumers are much more critical about skinirritation caused by a cosmetic product than about irritation caused by topical medication. An adverse reaction is considered to be any signs or symptoms triggered by atopical product used correctly (FISHER, 1995). Among cutaneous adverse reactionscaused by these products, the major ones are contact eczematous dermatitis, urticaria,acne and stains (SAMPAIO, & RIVITTI, 2000). The irritation potential of a product depends on a series of variables: componentsused, ingredient concentration, absorption, amount applied, skin condition, applicationmode and frequency, and cumulative effect (DOOMS-GOOSSENS, 1993). As human variability is very large, no food, medication or cosmetic products are fullyinnocuous. The term hypoallergenic is used for products with very little capacity toinduce an allergic reaction. Therefore, as a principle, all cosmetic products should behypoallergenic.ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT
  3. 3. RESEARCH PROTOCOL 3 of 8Revision 04 Tests conducted with humans are governed by very strict laws in order to protect andsafeguard people. These laws vary from country to country. In Brazil, these researches areallowed, provided that their protocols are approved by a Medical Ethics Committee, andcomply with the precepts of the Helsinki Declaration (CONSELHO NACIONAL DE SAÚDE[NATIONAL HEALTH COUNCIL], 1996). Patch tests are the main tool used to diagnose reactions caused by cosmetics andin allergenicity researches. As the key potential risks of using a new product areirritation, sensitization allergy, phototoxicity and photoallergy, the following clinical testsare involved in allergenicity researches: primary and accumulated dermal irritation,cutaneous sensitization, phototoxicity and photoallergy. These consist of repeatedapplications of the product to the skin. The purpose is to detect any possible irritations orinduction to sensitization (KLIGMAN & WOODING, 1967, FISHER, 1995). If the product passes the patch tests, it is important to carry out usage tests with thefinished product before it is introduced in the market (BARAN & MAIBACH, 1994).Besides allergenicity, this test can also assess sensorial characteristics of the product,and detect additional complaints and comments as to its performance. The company finds out about any possible considerations and complaints that willarise when the product is marketed, so it can develop strategies such as specific trainingfor its Consumer Service prior to product launch (BARAN & MAIBACH, 1994).2. OBJECTIVE The objective of this study is to evaluate by repetitive epidermal contact (RepeatedInsult Patch Test - RIPT) the allergenic (sensitization) potential and/or the cumulativecutaneous irritation potential of topical products and products like non-woven fabrics andfibers.ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT
  4. 4. RESEARCH PROTOCOL 4 of 8Revision 043. METHODS3.1. POPULATION AND SAMPLE At least fifty voluntary subjects of both sexes, phototypes I to IV (PATHAK, 1983), inthe 18-80 age range will be selected, should they have already been approved in amedical screening. Exclusion criteria will be: localized or generalized dermatologicaldiseases, presence of lesions or moles on the back of the subjects, use of any topicaland/or oral steroids and/or antihistamines for at least seven days prior to the start of thestudy, personal history of adverse reactions to the type of product going to be tested, aswell as pregnancy or nursing. The subjects will be submitted to an interview and to a dermatological examination.3.2. ETHICAL ASPECTS The subjects will be given explanations and guidance on the objectives and methodsof the research. They will be given proper instructions and sign a participation consent termelaborated according to Helsinki Declaration and approved by the Research EthicsCommittee (CONSELHO NACIONAL DE SAÚDE [NATIONAL HEALTH COUNCIL], 1996). They will be followed-up by specialist physicians in case they present any adversereactions to the test product.3.3. PRODUCT A sample of the test product will be catalogued and kept in our files for one year. The informations given by the contractor company on the test product will be attachedto the final report.3.4. REQUIRED MATERIAL AND EQUIPMENTS • Hypoallergenic adhesive cards for the patch test with 1 sq.-cm filter paper discs duly identified. • Semi-occlusive hypoallergenic tape. • Saline solution.ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT
  5. 5. RESEARCH PROTOCOL 5 of 8Revision 043.5. STUDY LENGTH This study will be accomplished in eight weeks.3.6. METHODOLOGY3.6.1. APPLICATION TECHNIQUE Cosmetics and other topical products: The product will be spread on a filter paper disk (0.05g/cm2), and the saline solution(control) on another disk. The disks will be attached to the right or left side of the back andcovered with semi-permeable hypoallergenic tape. Some products, such as hair coloring orhair straightening products, shampoos and toilet soaps, must be prepared and dilutedprevious to being applied on the disks. Non-woven fabrics and fibers: Prior to the initiation of the study the test product will be cut into squares ofapproximately 2.0 x 2.0 cm. The squares will be moistened with saline solution, attached to the right or left sides ofthe backs of the subjects and covered with a semi-occlusive hypoallergenic tape.3.6.2. EVALUATION The rating scale set by the International Contact Dermatitis Research Group (ICDRG)will be used (WILKINSON, 1970; FISHER, 1995). REACTION RESULT 0- none Negative (-) 1- slight erythema Doubtful (?) 2- clear erythema Positive (+) 3- erythema + edema + papules Positive (++) 4- erythema + edema + papules + vesicles Positive (+++)ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT
  6. 6. RESEARCH PROTOCOL 6 of 8Revision 043.6.3. CUMULATIVE IRRITATION AND SENSITIZATION RESEARCH - RIPT (KLIGMAN& WOODING, 1967; MARZULLI & MAIBACH, 1975) The patches will be applied always to the same duly protected areas (either right or leftside of the backs of the subjects). The product will be applied every day, and the firstapplication will remain in contact with the skin for 48 hours. On the weekend, the patch willremain on the site for 72 hours. The research will last three weeks, totaling fourteenapplications. The product will be re-applied always to the same sites, and the reactions will berecorded. After fourteen consecutive applications, a rest period of at least 14 days will befollowed, during which no patches will be applied. After this rest period, a single patch withthe sample will be applied either on the right or left side of the back of the subjects whereno patches have been applied before (virgin area). This patch will be removed after 48hours of contact with the skin. The reactions will be recorded 30 minutes and 24 hours afterremoval.3.7. STUDY DESIGN This will be a clinical single-blind randomized controlled study.3.8. RESULTS Any adverse reaction happening throughout the study period will be described on thefinal report.ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT
  7. 7. RESEARCH PROTOCOL 7 of 8Revision 044. REFERENCES BARAN, R. & MAIBACH, H.I., (ed.). Cosmetic Dermatology, Baltimore, Willians & Wilkins, 1994. CONSELHO NACIONAL DE SAÚDE [NATIONAL HEALTH COUNCIL]. Resolução 196/96 do Ministério da Saúde. Diário Oficial, 16/10/1996. DOOMS-GOOSSENS, A. Cosmetics as causes of allergic contact dermatitis. Cutis. 52: 316-320, 1993. FISHER, A.A. Contact Dermatitis, 2a edition, Philadelphia, Lea & Febiger, 1995. KLIGMAN, A.M. & WOODING, W.M. A method for the measurement and evaluation of irritants of human skin. J.Invest.Derm. 49:78-94, 1967. MARZULLI, F.N. & MAIBACH, H. I. The rabbit as a model for evaluating skin irritants: a comparison of results obtained on animals and man using repeated skin exposures. Fd. Cosmet. Toxicol. 13: 533-540, 1975. PATHAK, M.A. & COL. Photobiology of melanin pigmentation: dose/response of skin to sunlight and its contents. J.Am.Acad.Dermatol. 9: 724-733, 1983. SAMPAIO, S.A.P. & RIVITTI, E.A. Dermatologia Básica, 2a edição, São Paulo, Artes Médicas, 2000. WILKINSON, D.S. & COL. Terminology of contact dermatitis. Acta Dermatovener (Stockholm) 50: 287-292, 1970.ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT
  8. 8. RESEARCH PROTOCOL 8 of 8 Revision 04 HISTORY OF REVISIONRevision Revision Date Event Description 04 11/27/2006 Inclusion of one more reading in the item 3.6.3.Elaborated by: Approved by: ALLERGISA pesquisa dermato-cosmética ltda. Cumulative Irritation and Sensitization Potentials - RIPT