Randomised, split-face study of a dermocosmetic cream containing Sphingobioma xenophaga extract and Neurosensine® in subjects with rosacea associated with erythema and sensitive skin.

Abstract

Rosacea is a chronic inflammatory skin condition associated with erythema, inflammation and skin sensitivity. To assess the benefit of a dermocosmetic cream (DC cream) containing Sphingobioma xenophaga extract and soothing agent in adult females with rosacea-associated erythema and sensitive skin. During phase 1, DC was applied twice daily on the randomized half-face and compared to usual-skincare (USC) for 28 days. During phase 2, DC was applied on the full face twice daily for 56 days. Clinical, instrumental and skin sensitivity assessments were performed at all visits; demodex density (standardized skin surface biopsy (SSSB) method) was performed at baseline and D28, quality of life (QoL) was assessed using the stigmatization questionnaire (SQ), Rosacea Quality of Life index (ROSAQoL) and Dermatology Life Quality Index (DLQI) at baseline and D84. At D28, a significant benefit of DC over USC was observed for erythema, tightness, burning and stinging (all p≤0.05), erythema measured by chromameter (p<0.01), corneometry and transepidermal water loss (p<0.0001 and p<0.05, respectively), skin sensitivity (p<0.001) and significant reduction of mean demodex density (p<0.05) on the DC side. At D84, DC significantly (all p<0.05) improved clinical signs and symptoms on both sides of the face compared to baseline; SQ, ROSAQoL and DLQI scores improved by 40.4%, 25.0% and 55.7%, respectively compared to baseline. Tolerance was excellent. DC significantly improved erythema, skin sensitivity, demodex count, QoL and feeling of stigmatization of subjects with rosacea and is very well tolerated.