SMosE Safety and Efficacy Evaluation as a Skin Adaptogen

NCT06338046 | Completed DMC

• 1 other identifier: EAShi23M01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Acne Scars; Skin Barrier to Water Loss; Sebum Production

Outcome Measures

Primary Outcomes (1)

• Soothing Test

  SOOTHING ACTION EFFICACY

  2 months

Secondary Outcomes (1)

• Detox and adaptogen Test

  8 months

Study Arms (2)

Sample A - Active treatment

ACTIVE COMPARATOR

28-day-treatment, with twice daily application (morning and evening) of a cosmetic formula containing NC65 - Vita D-Light at 0.5 %w/w. The cosmetic formula is a w/o emulsion done with cosmetic-grade ingredients according to GMP. The designed quantity to be applied on the face is approximately 2 mg.

Other: Corthellus Shiitake(Mushroom) Extract

Sample B - Placebo treatment

PLACEBO COMPARATOR

28-day-treatment, with twice daily application (morning and evening) of a cosmetic formula containing the same ingredient of the active treatment except for NC65 - Vita D-Light at 0.5 %w/w. The cosmetic formula is a w/o emulsion done with cosmetic-grade ingredients according to GMP. The designed quantity to be applied on the face is approximately 2 mg.

Other: Placebo

Interventions

Corthellus Shiitake(Mushroom) Extract OTHER

topical treatment with Corthellus Shiitake(Mushroom) Extract

Also known as: NC65 - Vita D-Light

Sample A - Active treatment

Placebo OTHER

topical treatment with a placebo cosmetic formula

Also known as: Sample B

Sample B - Placebo treatment

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects scheduled for eligibility screening at the study site
• Female or Male sex
• Subjects with acne prone skin or skin with scar from acne
• Subjects exposed to sunlight for at least 4 hours a day
• Signing the informed consent form written by the investigators
• Certifying not taking part in another clinical study that could interfere with the current one
• Affirming the truth of the personal information declared to the technical staff
• Capable of following directions and reliable to respect the constraints of the protocol
• Free to ensure the visits to the Research Lab
• Subjects with self-perceived
• Subjects may have mild to sensitive and stressed skin

You may not qualify if:

• Female subjects who are pregnant, breastfeeding, or planning a pregnancy
• Subjects with severe overall photodamage as determined by the Investigator.
• Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
• Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
• Subjects' use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
• Subjects who spend excessive time out in the sun.
• Subjects who are unwilling or unable to comply with the requirements of the protocol.
• Subjects deprived of freedom by administrative or legal decision or under guardianship
• Subjects planning hospitalization during the study
• Subjectsaving received vaccination within 2 weeks before the study or intending to be vaccinated during the study
• Subjects with diseases in the period immediately preceding the current study under treatment topically or systemically with any drug that may affect the outcome of the test, particularly: systemic retinoids within 6 months, topical retinoids within 2 months anti-inflammatory or antihistamine products within the 2 weeks antibiotics within 2 weeks medication for malignancy (of any kind) within 5 years desensitization treatment within 6 months
• Subjects in treatments with topical products based on alpha and beta-hydroxy acids in the 45 days before the start of the study
• Subjects reactive to sun/having photosensitivity.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

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

Naples, 80131, Italy

Location

Study Officials

• Ritamaria Di Lorenzo

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: neither the patient nor the investigator knows who is getting which treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 2 parallel arm, double blind, randomized, placebo-controlled

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: October 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 22, 2023
• Last Updated: May 4, 2026

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)