Abstract
BACKGROUND: Sensitive skin is a syndrome characterized by unpleasant sensations in response to external stimuli. Its pathogenesis is linked to impaired skin barrier function, leading to neurovascular hyper-reactivity and inflammation. While topical functional skincare products are known to repair sensitive skin, there are limited reports on products specifically targeting the reduction of neurovascular hyper-reactivity. OBJECTIVE: To evaluate the efficacy and safety of a novel cream in improving neurovascular hyper-reactivity and subjective symptoms in sensitive skin. METHODS: This randomized, double-blind, self-controlled trial included 35 participants. One side of the face was treated with experimental cream (Group A) and the other with control cream (Group B), applied twice daily for 28 days. Follow-up assessments were performed on Day 0, Day 7, Day 14, and Day 28, with 28-day post-trial safety monitoring. Evaluations included clinical evaluation by physician, participant self-assessment of symptoms, measurements of skin physiological parameters and current perception threshold (CPT), lactic acid stinging test (LAST), capsaicin pain test (CAT), product usage experience, and participant tolerance. RESULTS: The experimental cream demonstrates good safety and user experience. Both the experimental and control creams effectively improve symptoms and signs of sensitive skin, increase SC hydration, and lower TWEL, LAST, and DLQI scores. Additionally, the experimental cream outperforms the control cream in improving pruritus, erythema, and TWEL. The experimental cream also has the unique advantage of reducing CAT scores and increasing CPT. CONCLUSION: The new cream has good safety and can effectively reduce neurovascular hyper-reactivity, alleviating symptoms in individuals with sensitive skin.