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COMPLETED
NCT06338046
NA

SMosE Safety and Efficacy Evaluation as a Skin Adaptogen

Sponsor: Federico II University

View on ClinicalTrials.gov

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

OTHER

Corthellus Shiitake(Mushroom) Extract

topical treatment with Corthellus Shiitake(Mushroom) Extract

OTHER

Placebo

topical treatment with a placebo cosmetic formula

Locations (1)

RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II

Naples, Italy