Eye Cream 8-Week Efficacy Clinical Study

NCT07079501 | Completed

• 1 other identifier: C25005004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

• 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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• Change in skin firmness score (Griffiths scale)

  Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)

• Change in skin elasticity score (Griffiths scale)

  Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)

• Change in skin smoothness score (Griffiths scale)

  Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)

• Change in skin plumpness score (Griffiths scale)

  Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)

• Change in crow's feet wrinkle volume (mm³)

  Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W)

Study Arms (1)

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.

Other: Test Eye Cream (Formula# 899675 44A)

Interventions

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.

Test Eye Cream Arm

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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\<grade≤ 4) Nasolabial folds (Atlas Page 52\~53, 1\<grade) Crow's feet wrinkle (Atlas Page 36\~37, 1\<grade) Inter ocular wrinkles (Atlas Page 38\~39, 1\<grade) Wrinkles of the corner of the lips (Atlas Page 60\~61, 1\<grade) Dark circle (vascular) (0-4 scale, 2≤ grade) Eye bags (Atlas Page 42-43, 2≤ grade) (at least N=10)
• No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
• In general good health at the time of the study.
• Willing and able to participate as evidenced by signing of informed consent and photo release form.
• Must be willing to comply with all study protocol requirements (pay attention to: only use the provided product during the study, not take topical or oral treatment like retinol, hormone, anti-oxidant health-care products which may impact the efficacy of study).

You may not qualify if:

• Pregnant or breast-feeding woman or woman planning pregnancy during the study.
• Subject deprived of rights by a court or administrative order. 3.Major subject to a guardianship order. 4.Subject residing in a health or social care establishment. 5.Patient in an emergency setting. 6.Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).
• Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.
• Subject presenting a stable or progressive serious disease (per investigator's assessment).
• Immuno-compromised subject. 10.Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
• Subjects regularly practicing aquatic or nautical sports. 12.Subjects regularly attending a sauna. 13.Subject with cardiovascular or circulatory history. 14.Subject with a history of skin cancer or malignant melanoma. 15.Anti-aging medical beauty project or anti-aging cosmetics clinical research in the last 6 months before study.
• Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.

Sponsors & Collaborators

• ChinaNorm: lead

Study Sites (1)

Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: November 17, 2024
• Primary Completion: February 14, 2025
• Study Completion: March 28, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (1)