Eye Cream 8-Week Efficacy Clinical Study
NCT07079501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-07-23
Summary
To investigate efficacy on test cream \[Formula#899675 44A\] on female subjects after 2-week wash-out and 8-week repeated application.
50 female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 40 subjects should complete the study in this 10-week study (wash-out phase for 2-week and treatment phase for 8 weeks). Subjects will need to refrain from using any product other than the provided products on face during the study phase.
1. Clinical Assessment (N=40 at least):
\*Clinical scoring for smoothness (visual), elasticity, cheek plumpness, radiance, global fine lines, firmness, dry lines, small folds on nasolabial zone (Atlas), underneath eye wrinkles (Atlas), forehead wrinkles (Atlas), nasolabial fold (Atlas), cheek folds: (Atlas), wrinkles of the corner of the lips (Atlas), inter-ocular wrinkles (Atlas), crow's feet wrinkles (Atlas), glabellar wrinkles (Atlas), horizontal neck fold (Atlas) by Dermatologist at T-2W, T0, Timm, T2W, T4W, T8W.
* Clinical scoring for eye bag (Atlas), intensity and coverage of dark circle (vascular) (0\~4 scale) by Dermatologist at T-2W, T0, T2W, T4W, T8W.
2. Image Capture and Analysis (N=40 at least):
\*The facial photo will be captured by VISIA CRP (Canfield, Gen 5.0) on left, front and right sides with Standard, Cross-polarized, Parallel-Polarized, Primos operated by trained technician at T0, Timm, T2W, T4W, T8W.
-Demo with mark line for forehead wrinkles, underneath eye wrinkles, crow's feet wrinkles
* Primos demo for crow's feet wrinkles
Image Analysis by Primos 5.8E:
-Wrinkle volume (mm³), Wrinkle area (mm²), total length (mm), count of crow's feet wrinkles
\*The facial photo will be captured by COLORFACE® (Newtone Technologies) on front side with closed eyes under Cross-Polarized mode at T0, T2W, T4W, T8W.
* Demo with dark circles.
Image Analysis by Image-Pro Plus 7.0:
* L\*, a\*, b\* and ITA° focus on underneath eye zone.
\*The local 3D photo will be captured by Primos-lite (Canfield) on both sides of underneath eye zone for eye bags by trained technician at T0, T2W, T4W, T8W. (at least 10 subjects with eye bags (Altas, 0\~6 scale) grade≥2)
* Demo with eye bags.
Image Analysis by Primos 5.8E:
-Rising Volume (mm³) of eye bags
Conditions
- Wrinkles and Rhytides
Interventions
- OTHER
-
Test Eye Cream (Formula# 899675 44A)
A white cream formulated as eye cream (Formula# 899675 44A) provided by L'Oréal R\&I China. Participants will apply 1ml of the product on the full face and neck twice daily for 8 weeks. The aim is to evaluate its efficacy on facial wrinkles, eye bags, dark circles, and other skin aging signs in healthy Chinese women.
Sponsors & Collaborators
-
ChinaNorm
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-17
- Primary Completion
- 2025-02-14
- Completion
- 2025-03-28
Countries
- China
Study Locations
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