In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY (Shitake)

This double-blind placebo-controlled study intends to confirm skin adaptogen and sebum balance efficacy of the investigational active ingredient NC65 - Vita D-Light, transmitted at 0.5% w/w in a topical cosmetic formulation, on a panel of healthy human subjects.

The study is performed by RD Cosmetics - University of Naples Federico II, from October to June 2024. The study involves female and male subjects, scheduled for eligibility screening at the study site. A total of 40 subjects were enrolled, and randomly divided into 2 groups: 20 subjects received the active treatment (cosmetic formulation with 0.5 %w/w NC65 - Vita D-Light) and 20 subjects the placebo one.

The cosmetic effectiveness of the products was instrumentally detected, using innovative, non-invasive and worldwide recognized devices for skin analysis, like:

• Corneometer CM 825 (C+K electronic GmbH) detects water's content of the stratum corneum.
• Tewameter® TM Hex (C+K electronic GmbH) detects the trans-epidermal water loss (TEWL).
• Sebumeter SM 815 accurately and reproducibly measures the level of sebum on the skin surface.
• Visia VISIA® (Canfield Scientific, Inc.) for skin surface assessment.

The monitored skin features parameters will be check after 1 hour (T1h) for the adaptogen test, and after 7, 14 and 28 days (T7 -T14-T28), for the detox test. Panelists will complete the self-assessment questionnaire at the end of the study period (T28).

Study Overview

• Status: Completed
• Conditions: SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY
• Intervention / Treatment: Other: Corthellus Shiitake(Mushroom) Extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sample A - Active treatment; 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; topical treatment with Corthellus Shiitake(Mushroom) Extract; Other Names: NC65 - Vita D-Light
Placebo Comparator: Sample B - Placebo treatment; 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; topical treatment with a placebo cosmetic formula; Other Names: Sample B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soothing Test	SOOTHING ACTION EFFICACY	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detox and adaptogen Test	SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY	8 months

Collaborators and Investigators

• Sponsor: Ritamaria Di Lorenzo
• Investigators: Principal Investigator: Ritamaria Di Lorenzo, Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: March 23, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EAShi23M01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No