J. Cosmet. Sci., 66, 79–86 (March/April 2015) 79 Effects of a new topical combination on sensitive skin A. FAUGER, A. LHOSTE, M. CHAVAGNAC-BONNEVILLE, M. SAYAG, and E. JOURDAN, Scientifi c and Research Department, Laboratoire Bioderma, Lyon, France. N. ARDIET, Centre d’Investigation et de REcherche Cutanée, Lyon, France. C. PERICHAUD and S. TROMPEZINSKI, Naos Recherche, Lyon, France. L. MISERY, Department of Dermatology, University Hospital of Brest, France and Laboratory of Neurosciences of Brest, University of Western Brittany, Brest, France. Accepted for publication February 1, 2015. Synopsis Using well-tolerated cosmetics or those with soothing effects is recommended to treat sensitive skin. How- ever, we lack clinical studies. Two clinical trials were performed on sensitive skin in France and Thailand. The primary objective was to evaluate the preventive soothing effect. The secondary objectives were to evaluate the immediate soothing effect, product tolerance, and impact on quality of life. Evaluation methods included a stinging test and scoring erythema and stinging intensity. We also assessed tolerance, quality of life using the Dermatology Life Quality Index, and cosmetic qualities. The clinical trials were performed in France and Thailand to test effi cacy in two different environments and on different ethnic skin. Interesting effects were observed in patients with sensitive skin in France and Thailand: a preventive soothing effect, a soothing effect on erythema, and an immediate soothing effect. In vivo biometrological, sodium lauryl sulfate, and capsaicin tests confi rmed these data. A favorable effect on quality of life was also noted. The product was appreciated by volunteers for its effi cacy, tolerance, and cosmetic qualities. A preliminary study on the effects on interleu- kin 8 was also included in the paper. INTRODUCTION “Sensitive skin” is defi ned as an erythema and/or unpleasant sensation (stinging, burning, pain, pruritus, and tingling) in response to multiple factors, which may be physical (UV, heat, cold, and wind), chemical (cosmetics, soap, water, detergents, and pollutants), and occasionally psychological (stress), or hormonal (menstrual cycle) (1–8). “Reactive,” “overreactive,” and “irritable” skin are synonyms of “sensitive” skin. The term “reactive skin” is more accurate than “sensitive skin,” which may be confused with “sensitized skin” due to an allergic disorder, but “sensitive skin” is more commonly used. Address all correspondence to Laurent Misery at laurent.misery@chu-brest.fr.

JOURNAL OF COSMETIC SCIENCE 80 Sensitive skin is very frequent. In France, approximately 50% of individuals (59% of women and 41% of men) report having reactive skin (9). This patient-reported preva- lence varies little across European countries (10), the United States of America (11), and Japan (12). Sensitive skin is clearly a very frequent cosmetic problem. Although the appearance of this kind of skin is normal in most cases, sensitive skin may occur in individuals who have another skin disorder (e.g., atopic dermatitis, seborrheic derma- titis, or rosacea) (9). The association with ethnicity is controversial (3,4,13). Three large epidemiological studies reported no “racial” differences when reporting sensitiv- ity (11,14,15), most likely because races or ethnicities do not exist (16). On the other hand, cultural factors (10–12) are most likely crucial for defi ning sensitive skin, related symptoms, and lifestyle factors that may favor several triggering factors. For example, Japanese women react more intensely than German women, even though there is no difference in the sensory innervation of their skin (17). The role of phototype has also been suggested (18). The debate is still out on how to treat sensitive skin. Using well-tolerated cosmetics or cosmetics with soothing effects, which decrease skin reactivity to insults, is recom- mended. In this study, we tested a cream made up of different compounds. Our aims were to have well tolerance, limit neurogenic and keratinocyte-induced infl amma- tion, and reinforce skin barrier function in two different environments and on differ- ent ethnic skin (France and Thailand). Preliminary biological studies were also presented. PATIENTS AND METHODS PRODUCT The tested cosmetic product (Sensibio Tolérance +®) is a cream containing sodium PCA (sodium l-pyrrolidone carboxylate 1%) and Neurocontrol® (1.25%), a combination of RMX (rhamnose, mannitol, and xylitol, which are three carbohydrates) and a tetrapep- tide [a transient receptor potential V1 (TRPV1) inhibitor]. In vitro studies. Human normal keratinocytes (HNK) from 3 different donors (Lonza, Belgium) were cultured (65,000 cells/well) with KBM [(keratinocyte basal medium) Lonza] and BPE (bovine pituitary extract), hEGF (human Epidermal Growth Factor), insulin, hydrocortisone, gentamicin, amphotericin B, epinephrine, and transferrin. The following day, the culture medium was replaced by the same medium supplemented or not with tested molecules (rhamnose, mannitol, xylitol and their association). After a 1-h incubation, tumor necrosis factor-α (TNF-α) (50 ng/ml) was added to induce interleukin 8 (IL-8) synthesis. After 24-h incubation, IL-8 amounts were measured by enzyme-linked immu- nosorbent assay (ELISA) (R&D Systems, Bristol, UK). Clinical studies. The primary objective was to evaluate the preventive soothing effect. The secondary objectives were to evaluate the immediate soothing effect, product tolerance, and its impact on quality of life. The studies were performed by Dermscan in France and Thailand under the same con- ditions, with the same cosmetic product. Inclusion criteria were women aged 18 years or older, an I-II-III-IV phototype (Fitzpatrick scale), sensitive skin on their face, a