In-Vitro Efficacy Investigation and an Open-Label, Single-Arm Clinical Study of a Gentle Micropeeling Cream for Sensitive and Non-Sensitive Skin

Abstract

Skin exfoliators, specifically alpha and beta hydroxy acids, have been shown to improve overall skin health and the clinical signs of aging. A micropeeling cream was developed with hydroxy acids and a brown algae extract and the efficacy and tolerability were evaluated in two parts. In the first part of the pre-clinical investigation, the micropeeling cream and the placebo control were evaluated by ELISA, immunostaining, qPCR and an activity assay using ex vivo and in vitro models. In the second part of the clinical efficacy study, 36 female subjects were enrolled for bioinstrumental measurements, visual imaging and clinical evaluation for 28 days. Fifty percent of subjects had sensitive skin. The ex-vivo study showed an increase in loricrin, superoxide dismutase 2, and extracellular matrix expression, without stimulating inflammatory biomarkers. The dermatologist observed a significant enhancement in all the parameters evaluated at day 28, and radiance, homogeneity, and roughness were significantly better after the first cream application. The homogeneity, desquamation and pore diameter showed significant improvement at day 7. The cream improved markers associated with skin aging and protection ex vivo. It was well tolerated, even on sensitive skin, and provided a significant improvement of fine lines, skin texture, and overall skin characteristics.