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

NCT ID: NCT06338046

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2023-12-22

Brief Summary

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).

Conditions

SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Corthellus Shiitake(Mushroom) Extract

Intervention Type: OTHER

topical treatment with Corthellus Shiitake(Mushroom) Extract

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

topical treatment with a placebo cosmetic formula

Interventions

Corthellus Shiitake(Mushroom) Extract

topical treatment with Corthellus Shiitake(Mushroom) Extract

Intervention Type: OTHER

Placebo

topical treatment with a placebo cosmetic formula

Intervention Type: OTHER

Other Intervention Names

NC65 - Vita D-Light; Sample B

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ritamaria Di Lorenzo

OTHER

Sponsor Role: lead

Responsible Party

Ritamaria Di Lorenzo

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ritamaria Di Lorenzo

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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

Naples, , Italy

Countries

Italy

Other Identifiers

EAShi23M01

Identifier Type: -

Identifier Source: org_study_id