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24 TESTING


necessity for tests with test subjects with skin diseases such as atopic dermatitis has also increased in recent years. The development of suitable test designs to deliver meaningful results is therefore particularly important. For testing itself, it is important that volunteers who correspond to the target group take part in the study as test subjects. Beside official guidelines and regulations,


Dermatest has own internal standards that go beyond the applicable regulations in Europe. All tests are only carried out if they are ethically acceptable since the health of test subjects is very important. Therefore, although demand is high,


Dermatest does not offer HRIPT. The HRIPT was developed over 70 years ago. It has been adapted only slightly over the years. The methodology itself and the validity of the results have been discussed for many decades. The problem is that there is no standardized test design, therefore no transparency for the consumer. In addition, even a HRIPT, developed


to induce allergies if a potential is present, cannot guarantee the security of products. Yet it leaves the risk for test subjects to develop an allergy that accompanies and restricts them for the rest of their lives. Test designs that provide a statement about the sensitizing potential are important, but must be ethically justifiable. The overall aim should be to use


experience and focus on the development of alternative, new and modern test designs with high informative value about the tolerability and sensitization potential of products without risk for participating volunteers and not explicitly triggering sensitization during the test procedure. Therefore, two new test designs have been published for this purpose within the least 12 months by Dermatest: Sensitive Seal and HypoSense. These test designs make claims such as “for sensitive skin” or “hypoallergenic” possible. The products are first evaluated theoretically by scientists and then tested in practice under the supervision of dermatologists and dermatological staff. Both methods developed are based on established tests and therefore provide a reliable statement on compatibility. The combination of the individual methods is new. This enables a comprehensive view and holistic assessment from a single source. Thus, they comprise not only a high-quality risk assessment of the ingredients but also a patch testing and a safety in-use study to ensure that the product is skin safe. Thereby, the HypoSense is more intense


because the safety in-use study is customized regarding inclusion and exclusion criteria and a longer application period analyses the sensitisation potential during actual usage. In addition, especially sensitive subject volunteers are included having sensitive and/ or atopic skin and/or suffering from asthma or allergies. Seeing a trend towards testing products


on subject volunteers with skin diseases, the HypoSense, meets the needs of the market exactly. Additionally, consumer can easily


PERSONAL CARE July 2024


400 370% 300 329% 200 188% 100 100% 0 2020 2021 2022 2023


Figure 4: Proportion of patch tests performed with volunteers with atopic skin. From 2020 to 2023, there is an increase in test performed on atopic skin. Even if the total number of tests on atopic skin is low compared to tests on sensitive skin or the number of standard patch tests, a clear trend can be seen


inform about the benefit of this testing as the method is transparently communicated. Future research is focusing on refining


existing testing methodologies and developing new ones, such as in vitro models that mimic sensitive skin responses and aim to replicate real-life conditions more closely. These advancements will not only improve


the accuracy of product tests but also aid in the development of products that are safe for sensitive skin users.


PC


References 1. Bataille A, Gall-Ianotto CL, Genin E, Misery L. Sensitive Skin: Lessons from Transcriptomic Studies. Front. Med. 2019; 6, 115


2. Misery L, Ständer S, Szepietowski JC, Reich A, Wallengren J, Evers AW, Takamori K, Brenaut E, Gall-Ianotto CL, Fluhr J et al. Definition of Sensitive Skin: An Expert Position Paper from the Special Interest Group on Sensitive Skin of the International Forum for the Study of Itch. Acta Derm. Venereol. 2017; 97, 4–6


3. Berardesca E, Farage M, Maibach H. Sensitive skin: An overview. Int. J. Cosmet. Sci. 2013; 35, 2–8


4. Farage MA. The Prevalence of Sensitive Skin. Front. Med. 2019; 6, 98


5. Misery, L.; Jourdan, E.; Abadie, S.; Ezzedine, K.; Brenaut, E.; Huet, F.; Sayag, M.; Taieb, C. Development and validation of a new tool to assess the Burden of Sensitive Skin (BoSS). J. Eur. Acad. Dermatol. Venereol. 2018; 32, 2217–2223


6. Kim YR, Cheon HI, Misery L, Taieb C, Lee YW. Sensitive skin in Korean population: An epidemiological approach. Skin Res. Technol. 2018; 24, 229–234


7. Brenaut E, Misery L, Taieb C. Sensitive Skin in the Indian Population: An Epidemiological Approach. Front. Med. 2019; 6, 29


8. Mikkelsen CS, Holmgren HR, Kjellman P, Heidenheim M, Kappinnen A, Bjerring P,


Huldt-Nystrøm T. Rosacea: A Clinical Review. Dermatol. Rep. 2016; 8, 6387


9. Wang XY, Liu YY, Liu YX, Ma WW, Zhang JW, Liu ZJ, Liu J, Zhou BR, Xu Y. A predictive model for differential diagnosis between rosacea and sensitive skin: A cross-sectional study. Chin. Med. J. 2020; 133, 2132–2134


10. Farage MA. Understanding the Sensitive Skin Subject to Achieve a More Holistic Diagnosis. Cosmetics. 2021; 8, 81


11. Barankin B, DeKoven J. Psychosocial effect of common skin diseases. Can. Fam. Physician. 2002; 48, 712–716


12. Farage MA, Neill S, MacLean AB. Physiological changes associated with the menstrual cycle: A review. Obstet. Gynecol. Surv. 2009; 64, 58–72


13. Falcone D, Richters RJ, Uzunbajakava NE, Van Erp PE, Van De Kerkhof PC. Sensitive skin and the influence of female hormone fluctuations: Results from a cross-sectional digital survey in the Dutch population. Eur. J. Dermatol. 2017; 27, 42–48


14. Farage MA. Does sensitive skin differ between men and women? Cutan. Ocul. Toxicol. 2010, 29, 153–163.


15. Farage MA, Mandl CP, Berardesca E, Maibach HI. Sensitive Skin in China. J. Cosmet. Dermatol. Sci. Appl. 2012; 2, 184–195


16. Farage MA. How do perceptions of sensitive skin differ at different anatomical sites? An epidemiological study. Clin. Exp. Dermatol. 2009, 34, e521–e530


17. Na M, Ritacco G, O’Brien D, Lavelle M, Api AM, Basketter D. Fragrance Skin Sensitization Evaluation and Human Testing: 30-Year Experience. Dermatitis. 2021; 32, 5


18. McNamee PM, Api AM, Basketter DA, Gerberick GF, Gilpin DA, Hall BM, Robinson MK. A review of critical factors in the conduct and interpretation of the human repeat insult patch test. Reg. Toxicol. and Pharmacol. 2008; 52, 24–34


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Increase in % of tests on atopic skin


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