MedTrace Logo

SMosE Safety and Efficacy Evaluation as a Skin Adaptogen

NCT06338046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Sebum Production
  • Acne Scars
  • Skin Barrier to Water Loss

Interventions

OTHER

Corthellus Shiitake(Mushroom) Extract

topical treatment with Corthellus Shiitake(Mushroom) Extract

OTHER

Placebo

topical treatment with a placebo cosmetic formula

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Ritamaria Di Lorenzo · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2023-11-15
Completion
2023-12-22

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06338046 on ClinicalTrials.gov