Clinical trial NCT06338046: In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY
Official title: In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel arm, double blind, randomized, placebo-controlled
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Soothing Test
timeFrame: 2 months
Secondary outcomes:
measure: Detox and adaptogen Test
timeFrame: 8 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Ritamaria Di Lorenzo
role: PRINCIPAL_INVESTIGATOR
References: