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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


NCT number NCT06338046
Study type Interventional
Source Federico II University
Contact
Status Completed
Phase N/A
Start date October 1, 2023
Completion date December 22, 2023