Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338046
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-23
Brief Title:
In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY
Sponsor:
Ritamaria Di Lorenzo
Organization:
Federico II University
Study Overview
Official Title:
In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Shitake
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 05 ww 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 05 ww 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 CK electronic GmbH detects waters content of the stratum corneum
Tewameter TM Hex CK 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
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 05 ww 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 CK electronic GmbH detects waters content of the stratum corneum
Tewameter TM Hex CK 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None