Primary Skin Irritation Safety Evaluation of Soothing and Moisturizing Mist by Skin Type in Middle-aged Women

This study aimed to evaluate the primary skin irritation response of a soothing and moisturizing mist product according to skin type in middle-aged women. Although the human application test was originally designed for healthy adults aged 19 to 64 years, the final analysis included data from 31 female participants who completed the test. The participants ranged in age from 43 to 61 years, with a mean age of 51.5 years. Based on the classification results provided by the testing institution, skin types were categorized as dry skin (n=12), normal skin (n=5), and combination skin (n=14). The test product, LAMÉCELL Soothing & Moisturizing MIST, and the negative control, tertiary purified water, were applied to the back area of each participant using a 24-hour closed patch test. Erythema and edema responses were evaluated by a physician at 30 minutes and 24 hours after patch removal, and the Primary Irritation Index (PII) was calculated based on the evaluation scores. As a result, no erythema or edema responses were observed at either the test product site or the negative control site. The PII of the test product was calculated as 0.00, and the product was classified within the non-irritation range under the present test conditions. No specific adverse reactions related to the test product were observed during the study period. These findings indicate that the soothing and moisturizing mist product did not show primary skin irritation responses under the present test conditions in an analysis group composed of middle-aged women with dry, normal, and combination skin types. The results should be interpreted as basic data for evaluating primary skin irritation responses of the finished mist formulation, rather than as evidence of moisturizing or soothing efficacy.