Clinical studies in Chinese subjects investigating the tolerance and soothing efficacy of a cream and balm containing 4-t-butylcyclohexanol on the sensitivity of facial skin.

Abstract

Asian subjects are particularly prone to skin sensitivity. We developed a facial cream and balm containing 4-t-butylcyclohexanol to provide skin comfort and a soothing effect for sensitive skin. Assess the dermatological and ophthalmological tolerance and efficacy in improving skin sensitivity of face cream and balm under normal conditions of use by a population known to be particularly prone to this problem. In a monocentric non-randomized open trial, the cream or balm was applied twice daily to the face, neck, and eye contour of 33 stinger subjects with hypersensitive skin (22-63 years old). Assessments included dermatological and ophthalmological physical and functional signs on Day 1 (D1), D8, and D22, and cosmetic acceptability, cutaneous sensitivity according to a stinging test and the sensitive scale, and the soothing efficacy according to a questionnaire on D22. The cream and balm were very well tolerated. Immediately after application, subjects reported a reduction in the skin's hypersensitivity (93.9% of subjects for the cream and 81.8% for the balm), skin redness (90.9% of subjects for the cream and 87.9% for the balm), sensations of tightness (93.9% for the cream and 97.0% for the balm), and discomfort sensations (93.9% for the cream and 87.9% for the balm). After 21 days, the application of the cream and balm decreased the stinging scores by 65% and 41%, respectively, with 94% and 77% of subjects showing an improvement, respectively. The sensitivity scale questionnaire indicated that the cream and balm significantly and profoundly decreased all negative signs, for example, irritability, stinging, general discomfort, redness, and dryness on D22 compared to D1. On D22, all 15 parameters recorded were improved by 89%-100% by the cream and by 74%-100% by the balm. The majority (90.9% and 96.8% of subjects using the cream and balm, respectively) of the subjects noticed positive changes in their skin condition after using the product for 21 days. The cream and balm were very well-tolerated. This study demonstrated that both products controlled and markedly reduced skin hypersensitivity in Asian subjects, with an immediate and lasting skin soothing and repairing effect over 21 days.