Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03881189
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2019-03-18
Brief Title:
Efficacy and Tolerance Evaluation of an Injective Treatment for the Area Around the Eyes
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment for the Area Around the Eyes
Status:
COMPLETED
Status Verified Date:
2019-03
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:
None
Brief Summary:
Efficacy and tolerance evaluation of an intradermal injective HA and aminoacids based treatment for the area around the eyes
Detailed Description:
Primary end point of this study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance on the area around the eyes of theSUNEKOS 200 injective treatment Precisely three micro-injection sessions with an interval of 15 days were performed by a specialized dermatologist using periosteal and subepidermal injection techniques on the area around the eyes of female volunteers with dark circles
An additional aim of this study is to evaluate the product tolerance by both the investigator and volunteers
An additional aim of this study is to evaluate the product tolerance by both the investigator and volunteers
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