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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.
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.
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
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Eye Cream Arm | Experimental | Participants will apply the test eye cream (Formula# 899675 44A) twice daily on full face and neck for 8 weeks. The study is designed to evaluate improvements in facial wrinkles, eye bags, dark circles, skin firmness, elasticity, radiance, and smoothness in healthy Chinese women aged 20-50. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Eye Cream (Formula# 899675 44A) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wrinkle severity score assessed by dermatologist using Skin Aging Atlas | Clinical evaluation of facial wrinkles including crow's feet, forehead wrinkles, glabellar lines, nasolabial folds, and eye wrinkles using the Skin Aging Atlas (0-9 scale), conducted by a dermatologist. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin firmness score (Griffiths scale) | Dermatologist grading of skin elasticity using a modified Griffiths scale (0-9), based on tactile skin rebound assessment. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W) |
| Change in skin elasticity score (Griffiths scale) |
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Inclusion Criteria:
Prospective subjects meeting all the criteria below will be eligible for enrolment:
Chinese women aged from 20-50 years old (must have subjects aged from 20-30 y.o.).
All skin types, with about 50% sensitive skin (self-declared).
Regular users of cleanser, anti-aging cream and sunscreen products.
Self-claim with wrinkles concern, also with lack of elasticity, firmness and plumpness.
Clinical grading by dermatologist on global face following:
Skin firmness (0-9 scale, 3≤ grade≤ 6) Skin elasticity (0-9 scale, 3≤ grade≤ 6) Skin radiance (0-9 scale, 3≤ grade≤ 6) Skin smoothness (0-9 scale, 3≤ grade≤ 6) Skin plumpness (0-9 scale, 3≤ grade≤ 6)
Clinical grading by dermatologist on face following:
Underneath eye wrinkles (Atlas Page 44~45, 2≤ grade≤ 5) Forehead wrinkles (Atlas Page 30~31, 1\
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072 | Shanghai | China |
This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
18-Month Duration: The data sharing period starts upon study completion and PRS registration completion.
Timeline:
Months 2-3: Data de-identification, metadata preparation, and platform integration.
Month 4: Official launch of data access.
Primary Platform:
ResMan (www.medresman.org.cn) - China's leading medical research data repository.
Eligibility:
Researchers/affiliates from academic institutions, hospitals, or registered research organizations.
Engaged in dermatology, cosmetic science, or related fields. Able to demonstrate ethical compliance and data security capabilities.
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|
Dermatologist grading of skin elasticity using a modified Griffiths scale (0-9), based on tactile skin rebound assessment. |
| Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W) |
| Change in skin smoothness score (Griffiths scale) | Dermatologist evaluation of skin smoothness using a 0-9 modified Griffiths scale based on visual observation and tactile texture. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W) |
| Change in skin plumpness score (Griffiths scale) | Dermatologist evaluation of skin radiance based on facial glow and uniformity, scored using a modified Griffiths 0-9 scale. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W) |
| Change in crow's feet wrinkle volume (mm³) | Quantitative evaluation of wrinkle volume using Primos 5.8 3D imaging system. Measurement includes wrinkle volume (mm³) in the crow's feet region. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W) |
| Change in crow's feet wrinkle area (mm²) | Quantitative evaluation of wrinkle area using Primos 5.8 3D imaging. Area (mm²) of the crow's feet region analyzed. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W) |
| Change in crow's feet wrinkle count | Counting of visible crow's feet wrinkles using Primos 5.8 system under standardized imaging conditions. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W) |
| Change in under-eye dark circle pigmentation (L*, a*, b*, ITA° values) | Colorface® and Image-Pro Plus 7.0 analysis of pigmentation under cross-polarized light. Parameters include L*, a*, b*, and ITA° in the under-eye zone. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W) |
| Change in eye bag volume (mm³) | 3D volume assessment of under-eye bags using Primos imaging, reported in mm³. At least 10 participants must present with baseline eye bag score ≥2. | Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W) |