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SMosE Safety and Efficacy Evaluation as a Skin Adaptogen
Sponsor: Federico II University
Summary
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.
Official title: Evaluation of the Efficacy and Safety of a Shiitake Mushroom Oil-Soluble Extract (SMosE) on Skin Barrier Function, Sebum Regulation, and Adaptive Responses: Preclinical and Clinical Investigation
Key Details
Gender
All
Age Range
25 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-10-01
Completion Date
2023-12-22
Last Updated
2026-05-04
Healthy Volunteers
Yes
Interventions
Corthellus Shiitake(Mushroom) Extract
topical treatment with Corthellus Shiitake(Mushroom) Extract
Placebo
topical treatment with a placebo cosmetic formula
Locations (1)
RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II
Naples, Italy