Wrinkles and RhytidesNCT07079501
Eye Cream 8-Week Efficacy Clinical Study
A study testing Test Eye Cream (Formula# 899675 44A) in people with Wrinkles and Rhytides, run by ChinaNorm at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles and Rhytides
- What is being tested?
- Test Eye Cream (Formula# 899675 44A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2024to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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).
Who cannot join
- 1.Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- 2.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).
- 7.Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.
- 8.Subject presenting a stable or progressive serious disease (per investigator's assessment).
- 9.Immuno-compromised subject. 10.Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- 11.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.
- 16.Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
Shanghai
About this study
Official title: 8-week Efficacy Clinical Study on Chinese Healthy Female, 40 Subjects
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.
Read more
- 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.
- 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
- Being tested
- Test Eye Cream (Formula# 899675 44A)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Test Eye Cream (Formula# 899675 44A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)
Secondary outcomes (9)
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.
Measured: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)
Change in skin elasticity score (Griffiths scale)
Dermatologist grading of skin elasticity using a modified Griffiths scale (0-9), based on tactile skin rebound assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start17 Nov 2024
- Primary completion14 Feb 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles and RhytidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079501
- Sponsor's protocol ID
- C25005004
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 8-week Efficacy Clinical Study on Chinese Healthy Female, 40 Subjects
- ClinicalTrials.gov ID
- NCT07079501
- Acronym / sponsor ID
- C25005004
- Conditions
- Wrinkles and Rhytides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Eye Cream Arm | Experimental | Other: Test Eye Cream (Formula# 899675 44A)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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (7 listed)
- 1.Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- 2.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).
- 7.Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.
- 8.Subject presenting a stable or progressive serious disease (per investigator's assessment).
- 9.Immuno-compromised subject. 10.Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Test Eye Cream Arm |
Primary outcome
Change in wrinkle severity score assessed by dermatologist using Skin Aging Atlas
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)
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.
9 secondary outcomes
Change in skin firmness score (Griffiths scale)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)
Change in skin elasticity score (Griffiths scale)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)
Change in skin smoothness score (Griffiths scale)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)
Change in skin plumpness score (Griffiths scale)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)
Change in crow's feet wrinkle volume (mm³)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W)
Change in crow's feet wrinkle area (mm²)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W)
Change in crow's feet wrinkle count
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W)
Change in under-eye dark circle pigmentation (L*, a*, b*, ITA° values)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W)
Change in eye bag volume (mm³)
Time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), Day 56 (T8W)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Eye Cream (Formula# 899675 44A) in people with Wrinkles and Rhytides, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wrinkle severity score assessed by dermatologist using Skin Aging Atlas (time frame: Baseline (T0), Day 14 (T2W), Day 28 (T4W), and Day 56 (T8W)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.