22 TESTING Normal skin ■ Sensitive test ■ All test persons Male test persons Female test persons
Female test persons >40 years
Figure 1: Distribution of test persons with sensitive skin and normal skin. Subject database analysis from over 5,000 data records
extensive testing on a wide array of products, employing methodologies, to ensure they are suitable for specific skin types like sensitive skin.
Thereby, patch tests provide good
information about general skin tolerance and irritation potential of products. In addition, they can also be carried out on test subjects with different skin types (e.g. sensitive skin) to analyse the tolerability skin specifically. Clinical safety in-use studies with test subjects having sensitive skin are advantageous as these are true-to-life testing. Products are used in the intended area
of application over a longer period of time and the efficacy and positive effects of the products can be determined in addition to skin tolerance. Skin parameters such as erythema, hydration, and transepidermal water loss can be measured to assess the product’s impact. In addition, direct subjective feedback on
the product compatibility and efficacy can be obtained and participants provide feedback on their experience with the product. Finally, each method has its advantages and limitations, and a combination of approaches is often used to comprehensively evaluate the safety and
Surfactant UV-Filter Propoplis
Colophonium (Rosin) Lanolin (-derivatives)
Cetyl/Cetearyl Alcohol (-derivatives) Chamomilla ingredients
p-Phenylenediamine (-derivatives) Preservatives Azo Dyes
Allergenic Fragrances 0 20 40 60 80 100 120 140 160 180
Figure 2: Summary of excludes ingredient groups when tested for Dermatest's sensitive seal and HypoSense. In total, more than 330 different ingredients listed that are known for their sensitising or irritant potential
PERSONAL CARE July 2024
efficacy of cosmetic products for sensitive skin. Yet for each study the clinical evaluation by
dermatologists or trained clinicians is essential to guarantee meaningful studies and should be mandatory. Nevertheless, still studies without dermatologist exist. Additionally, it is essential to adhere to
ethical guidelines and ensure participant safety throughout the testing process. The benefit of each study should always overweigh the risk.
Detailed analysis of findings For over 45 years, Dermatest has been conducting independent dermatological studies with volunteers for cosmetics manufacturers. Two aspects are of the utmost importance: precise scientific test results for customers and the protection of test subjects. Therefore, Dermatest ensures that all
products are approved by safety assessors before they are tested by subjects. The examination of the ingredients in advance and precise planning of the test are crucial for the validity of the results. To examine the demographic distribution in Dermatest subjects a database analysis
was conducted. The database comprises over 5,000 actively participating individuals, provides an insight into the prevalence and distribution of sensitive skin (Figure 1). Approximately 34% of all subjects report
sensitive skin, with a higher prevalence among females (37.7%) than males (28%). Notably, sensitivity increases with age, particularly in females over 40, where the prevalence is as high as 41.8%. This demographic insight is crucial for targeting cosmetic product development and testing protocols. Therefore, Dermatest offers specific and
customized test designs for products that are intended for sensitive skin. The basic analyses can be performed with patch and/or application studies on subjects with sensitive skin. Beside this, Dermatest has developed special combination studies, Sensitive Seal Study and HypoSense. Both methods fulfil even higher criteria than
those of the European Cosmetics Regulation (EC) 1223/2009. Only certain products and product compositions are authorised for these combination studies. For example, a total of 330 ingredients according to INCI are excluded for these combination studies. As presented in Figure 2, exclusion criteria
are ingredient groups with known allergenic, sensitising or irritant potential, e.g allergenic fragrances, azo dyes, certain preservatives (formaldehyde releasers, parabens, thiazolinones, methyldibromo glutaronitrile), colophonium (rosin), chamomilla ingredients, lanolin and derivatives, propolis, cetyl/ cetearyl alcohol and derivatives, the UV filter benzophenone-3, para-phenyldiamine and derivatives and the surfactant sodium lauryl sulfate.
This list is continuously updated due to
current scientific discussions, publications and experience and knowledge by Dermatest. These criteria ensure that only products
with ingredients suitable for sensitive skin are included in testings with volunteers. To increase the transparency of these studies for consumer, a specific seal of approval, Sensitive Seal, and HypoSense have been developed. The need for safety tests for sensitive skin
is clearly reflected in the increase in testing on sensitive skin by customized studies by Dermatest. From 2020 to 2023, Dermatest
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