SMosE Safety and Efficacy Evaluation as a Skin Adaptogen

Overview

This study evaluates the biological activity, safety, and clinical efficacy of SMosE (Shiitake Mushroom Oil-Soluble Extract), a topical cosmetic ingredient developed to support skin barrier function, adaptogenic responses, and sebum balance. The investigation integrates preclinical in vitro studies, ex vivo human skin explant experiments, and a randomized, double-blind, placebo-controlled clinical trial. Preclinical models were used to explore the molecular mechanisms of action of SMosE on epidermal differentiation and barrier-related markers. The clinical phase assessed the effects of a topical formulation containing SMosE on skin hydration, transepidermal water loss, sebum production, and skin surface features in adult volunteers.

Background and Rationale: Skin homeostasis depends on the integrity of the epidermal barrier, balanced sebum production, and the ability of the skin to adapt to environmental stressors. Cosmetic ingredients with adaptogenic properties are increasingly investigated as non-invasive strategies to support these functions. SMosE is an oil-soluble extract obtained from Lentinus edodes (shiitake mushroom), developed for topical use. Preliminary data suggest that SMosE may promote epidermal differentiation, improve barrier-related protein expression, and modulate sebum-related pathways. Preclinical Evaluation: Ex Vivo Human Skin Explant Study: To confirm biological relevance in intact human tissue, ex vivo studies were performed on human skin explants. Human skin explants were obtained from three healthy female donors, aged 26 to 40 years, who underwent abdominoplasty or breast reduction surgery. All donors provided written informed consent for the use of their skin tissues in accordance with the Declaration of Helsinki. Then, protein expression of epidermal differentiation and barrier markers, including cytokeratin 10 and claudin-1, was evaluated by immunofluorescence microscopy. Clinical Study Design: The clinical phase was designed as a randomized, double-blind, placebo-controlled, parallel-group cosmetic study conducted at a single center. A total of 40 adult male and female volunteers with oily and/or acne-prone skin were enrolled and randomized in a 1:1 ratio to receive either: a topical formulation containing SMosE, or a placebo formulation identical in composition except for the absence of the active ingredient. Participants applied the assigned product to the face once daily for 28 consecutive days. Clinical Assessments: Skin evaluations were performed at baseline and during follow-up visits under controlled environmental conditions using validated, non-invasive instruments to assess hydration, barrier function, sebum production, and skin surface features. Safety and Ethics : Skin tolerability was assessed prior to and throughout the study. Adverse events were monitored and recorded. All participants provided written informed consent. The study was conducted in accordance with the principles of the Declaration of Helsinki and applicable guidelines for cosmetic clinical research.