Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807620
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2023-03-20
Brief Title:
A 12 Week Study to Evaluate the Efficacy of an Eye Cream
Sponsor:
Revision Skincare
Organization:
Revision Skincare
Study Overview
Official Title:
A Clinical Study to Evaluate the Efficacy and Tolerability of an Eye Cream for Moderate to Severe Dark Circles and Undereye Puffiness
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This single center open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles moderate under eye puffiness and mild fine lines and wrinkles A total of 37 subjects were enrolled into the study
Detailed Description:
This single center open-label clinical study was conducted to evaluate the efficacy and tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with Fitzpatrick Skin Type I - VI and moderate to severe dark circles and under-eye puffiness This study aims to evaluate the following objectives
1 To evaluate the eye cream impact on undereye dark circles undereye puffiness fine lines and wrinkles periorbital eye area and overall appearance periorbital eye area as evaluated by investigator clinical grading chromameter VISIA clinical photography and subjective questionnaire performed at baseline week 4 week 8 and week 12
2 To evaluate the eye cream impact on under eye blood flow as evaluated by laser doppler performed at baseline week 8 and week 12
3 To assess objective and subjective tolerability of Dryness Erythema and Edema and Burning Stinging Peeling and Itching evaluated by investigator and subjective grading at baseline week 4 week 8 and week 12
A total of 37 subjects completed the study
1 To evaluate the eye cream impact on undereye dark circles undereye puffiness fine lines and wrinkles periorbital eye area and overall appearance periorbital eye area as evaluated by investigator clinical grading chromameter VISIA clinical photography and subjective questionnaire performed at baseline week 4 week 8 and week 12
2 To evaluate the eye cream impact on under eye blood flow as evaluated by laser doppler performed at baseline week 8 and week 12
3 To assess objective and subjective tolerability of Dryness Erythema and Edema and Burning Stinging Peeling and Itching evaluated by investigator and subjective grading at baseline week 4 week 8 and week 12
A total of 37 subjects completed the study
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