Skin Aging of Face and NeckNCT07403942
The Skin Anti-Aging Effects of Vitamin K2 (MK-7): a Clinical Split-Face/Neck Trial
A study testing Face-and-Neck Cream (with 0.05% Vitamin K2) in people with Skin Aging of Face and Neck, run by Nanjing Ascend Biotech Technology Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of a facial and neck cream containing Vitamin K2 in improving skin hydration, elasticity, firmness, and reducing wrinkles in 36 female participants aged 35-60 years with concerns of facial dryness, dullness, laxity, and neck lines. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging of Face and Neck
- What is being tested?
- Face-and-Neck Cream (with 0.05% Vitamin K2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2024to 19 May 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a Chinese female aged between 35 and 60 years (inclusive).
- Presents with facial skin concerns including dryness, dullness, and laxity.
- Has crow's feet (outer canthus wrinkles) with a visual assessment grade of 2 to 4 (on a 0-6 scale).
- Self-reports concerns about neck wrinkles.
- Is in good general health at the time of screening.
- Is willing and able to provide written informed consent.
- Is willing and able to comply with all study procedures and product usage requirements for the duration of the study.
Who cannot join
- Is planning pregnancy, is pregnant, lactating, or within 6 months postpartum.
- Has a history of severe systemic diseases, immunodeficiency, or autoimmune diseases.
- Has a history of allergic diseases or has experienced cosmetic allergies within the past 1-2 years.
- Has had dermatological diseases on the test areas (face and neck) or is undergoing related medical treatment within the past 3 months.
- Has an active cold, influenza, or other acute illness at the study start that may affect participation.
- Is currently participating, or has participated within the past month, in another clinical study involving the test areas.
- Is deemed unsuitable for participation by a dermatologist's assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Sino-German Union Cosmetic Institute Co., Ltd.
Beijing, 100123
About this study
Official title: Cosmetic Efficacy Testing
The goal of this clinical trial is to evaluate the efficacy of a facial and neck cream containing Vitamin K2 in improving skin hydration, elasticity, firmness, and reducing wrinkles in 36 female participants aged 35-60 years with concerns of facial dryness, dullness, laxity, and neck lines. The main questions it aims to answer are:
Does the test cream significantly improve skin hydration (Corneometer), reduce transepidermal water loss (Vapometer), and enhance skin elasticity and firmness (Cutometer) compared to a control cream?
Read more
Does the test cream significantly reduce wrinkle severity (assessed by Rz and Ra parameters via AEVA-HE rapid optical imaging) in areas including the neck, cheeks, marionette lines, and crow's feet compared to a control cream?
Researchers will compare the test cream (applied to one randomized half-face and neck) to the control cream (applied to the contralateral half-face and neck) to see if the test cream demonstrates superior efficacy in improving the measured skin parameters.
Participants will:
Apply the test cream to one assigned side of the face and neck, and the control cream to the other side, twice daily for 8 weeks.
Attend evaluation visits at baseline, 2, 4, and 8 weeks for instrumental measurements (skin hydration, TEWL, elasticity, rapid optical imaging, facial imaging) and to complete subjective questionnaires.
- Conditions
- Skin Aging of Face and Neck
- Being tested
- Face-and-Neck Cream (with 0.05% Vitamin K2), Placebo Face-and-Neck Cream
- Keywords
- Vitamin K2, MK-7, Skin Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-and-Neck Cream (with 0.05% Vitamin K2)Other
Also called Face-and-Neck Cream (with 0.05% BioYoung™ MK-7)
This is a topical cosmetic cream (face and neck cream) containing 0.05% BioYoung™ MK-7 (Vitamin K2) as the key active ingredient. The product is a white to light yellow cream, supplied in plastic bottles. Each participant applies this cream to one randomly assigned half of the face and neck. The application regimen is twice daily (morning and evening), using approximately 0.5g per application, for a duration of 8 weeks.
Placebo Face-and-Neck CreamOther
This is the control topical cosmetic cream (face and neck cream). It is the base formulation identical to the test cream but without the addition of Vitamin K2. The product is a white to light yellow cream, supplied in plastic bottles. Each participant applies this cream to the contralateral half of the face and neck (opposite to the test product side). The application regimen is twice daily (morning and evening), using approximately 0.5g per application, for a duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Face-and-Neck Cream | Placebo comparator | Participants apply the Placebo Face-and-Neck Cream (base formulation without Vitamin K2) to the contralateral half of the face and neck. Used twice daily (morning and evening) for 8 weeks. Receives: Other: Placebo Face-and-Neck Cream |
| Face-and-Neck Cream | Active comparator | Participants apply the Face-and-Neck Cream (containing 0.05% Vitamin K2) to one randomly assigned half of the face and neck. Used twice daily (morning and evening) for 8 weeks. Receives: Other: Face-and-Neck Cream (with 0.05% Vitamin K2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Facial Skin Elasticity (R0, R1 and F4)
Assessed using a Cutometer MPA580.Measurements are taken on the cheek area. R0 (Uf) represents the maximum skin deformation under suction. A lower R0 value indicates greater resistance to tensile deformation, reflecting superior skin firmness.
R1 (Uf - Ua) quantifies the immediate elastic recovery after suction release. A lower R1 value signifies faster restoration to baseline morphology, demonstrating enhanced skin elasticity.
F4, the viscoelastic fatigue parameter, quantifies energy dissipation during cyclic skin deformation. A lower F4 value indicates enhanced viscoelastic integrity of the skin.
Measured: At Baseline, Week 2, Week 4, and Week 8
Change in Roughness Parameters (Ra and Rz ) of Face and Neck Wrinkles
Assessed by AEVA-HE rapid optical imaging system. Ra represents the arithmetic average of absolute deviations of skin surface profile points from the mean line across the entire assessment length. It quantifies the overall smoothness of the skin surface. Lower Ra values indicate smoother skin with less pronounced wrinkle formation.
Rz is calculated by dividing the skin surface profile into five equal sampling lengths. The parameter represents the arithmetic mean of the distances between the highest peaks and deepest valleys within each segment, quantifying the extreme variations in skin surface topography. As a key indicator of macro-textural irregularities, lower Rz values correspond to reduced skin unevenness.
Measured: At Baseline, Week 2, Week 4, and Week 8
Change in Facial Sagging (Mandibular Plane Angle)
Quantified by analyzing standard white-light photographs taken with a VISIA imaging system. The mandibular plane angle is measured in degrees (°) using image analysis software (Image-Pro Plus). An increase in the angle indicates a sharper, more defined, and firmer jawline contour.
Measured: At Baseline, Week 2, Week 4, Week 8
Secondary outcomes (2)
Change in Skin Hydration
Measured by a Corneometer CM825 on the cheek. Values are expressed in arbitrary units (a.u.). A higher value indicates better skin hydration.
Measured: At Baseline, Week 2, Week 4, Week 8
Change in Facial Transepidermal Water Loss (TEWL)
Measured in grams per square meter per hour (g/m²h) using a standardized vapometer (Vapometer, SWL5201) under controlled environmental conditions (21 ± 1°C, 50 ± 10% RH). Measurements were taken on the cheek area (zygomatic region). A lower value indicates reduced water loss and improved skin barrier function.
Measured: At Baseline, Week 2, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start26 Dec 2024
- Primary completion20 Feb 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Aging of Face and NeckStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Ascend Biotech Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403942
- Sponsor's protocol ID
- 2024-293-ZH-262
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Efficacy Testing
- ClinicalTrials.gov ID
- NCT07403942
- Acronym / sponsor ID
- 2024-293-ZH-262
- Conditions
- Skin Aging of Face and Neck
- Keywords
- Vitamin K2, MK-7, Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nanjing Ascend Biotech Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 11 Feb 2026 (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.
The goal of this clinical trial is to evaluate the efficacy of a facial and neck cream containing Vitamin K2 in improving skin hydration, elasticity, firmness, and reducing wrinkles in 36 female participants aged 35-60 years with concerns of facial dryness, dullness, laxity, and neck lines. The main questions it aims to answer are:
Does the test cream significantly improve skin hydration (Corneometer), reduce transepidermal water loss (Vapometer), and enhance skin elasticity and firmness (Cutometer) compared to a control cream?
Does the test cream significantly reduce wrinkle severity (assessed by Rz and Ra parameters via AEVA-HE rapid optical imaging) in areas including the neck, cheeks, marionette lines, and crow's feet compared to a control cream?
Researchers will compare the test cream (applied to one randomized half-face and neck) to the control cream (applied to the contralateral half-face and neck) to see if the test cream demonstrates superior efficacy in improving the measured skin parameters.
Participants will:
Apply the test cream to one assigned side of the face and neck, and the control cream to the other side, twice daily for 8 weeks.
Attend evaluation visits at baseline, 2, 4, and 8 weeks for instrumental measurements (skin hydration, TEWL, elasticity, rapid optical imaging, facial imaging) and to complete subjective questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Face-and-Neck Cream | Placebo comparator | Other: Placebo Face-and-Neck CreamParticipants apply the Placebo Face-and-Neck Cream (base formulation without Vitamin K2) to the contralateral half of the face and neck. Used twice daily (morning and evening) for 8 weeks. |
| Face-and-Neck Cream | Active comparator | Other: Face-and-Neck Cream (with 0.05% Vitamin K2)Participants apply the Face-and-Neck Cream (containing 0.05% Vitamin K2) to one randomly assigned half of the face and neck. Used twice daily (morning and evening) for 8 weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Is a Chinese female aged between 35 and 60 years (inclusive).
- Presents with facial skin concerns including dryness, dullness, and laxity.
- Has crow's feet (outer canthus wrinkles) with a visual assessment grade of 2 to 4 (on a 0-6 scale).
- Self-reports concerns about neck wrinkles.
- Is in good general health at the time of screening.
Key exclusion criteria (7 listed)
- Is planning pregnancy, is pregnant, lactating, or within 6 months postpartum.
- Has a history of severe systemic diseases, immunodeficiency, or autoimmune diseases.
- Has a history of allergic diseases or has experienced cosmetic allergies within the past 1-2 years.
- Has had dermatological diseases on the test areas (face and neck) or is undergoing related medical treatment within the past 3 months.
- Has an active cold, influenza, or other acute illness at the study start that may affect participation.
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 |
|---|---|---|
| Face-and-Neck Cream (with 0.05% Vitamin K2)Also: Face-and-Neck Cream (with 0.05% BioYoung™ MK-7)This is a topical cosmetic cream (face and neck cream) containing 0.05% BioYoung™ MK-7 (Vitamin K2) as the key active ingredient. The product is a white to light yellow cream, supplied in plastic bottles. Each participant applies this cream to one randomly assigned half of the face and neck. The application regimen is twice daily (morning and evening), using approximately 0.5g per application, for a duration of 8 weeks. | Other | Face-and-Neck Cream |
| Placebo Face-and-Neck CreamThis is the control topical cosmetic cream (face and neck cream). It is the base formulation identical to the test cream but without the addition of Vitamin K2. The product is a white to light yellow cream, supplied in plastic bottles. Each participant applies this cream to the contralateral half of the face and neck (opposite to the test product side). The application regimen is twice daily (morning and evening), using approximately 0.5g per application, for a duration of 8 weeks. | Other | Placebo Face-and-Neck Cream |
Primary outcome
Change in Facial Skin Elasticity (R0, R1 and F4)
Time frame: At Baseline, Week 2, Week 4, and Week 8
Assessed using a Cutometer MPA580.Measurements are taken on the cheek area. R0 (Uf) represents the maximum skin deformation under suction. A lower R0 value indicates greater resistance to tensile deformation, reflecting superior skin firmness. R1 (Uf - Ua) quantifies the immediate elastic recovery after suction release. A lower R1 value signifies faster restoration to baseline morphology, demonstrating enhanced skin elasticity. F4, the viscoelastic fatigue parameter, quantifies energy dissipation during cyclic skin deformation. A lower F4 value indicates enhanced viscoelastic integrity of the skin.
Change in Roughness Parameters (Ra and Rz ) of Face and Neck Wrinkles
Time frame: At Baseline, Week 2, Week 4, and Week 8
Assessed by AEVA-HE rapid optical imaging system. Ra represents the arithmetic average of absolute deviations of skin surface profile points from the mean line across the entire assessment length. It quantifies the overall smoothness of the skin surface. Lower Ra values indicate smoother skin with less pronounced wrinkle formation. Rz is calculated by dividing the skin surface profile into five equal sampling lengths. The parameter represents the arithmetic mean of the distances between the highest peaks and deepest valleys within each segment, quantifying the extreme variations in skin surface topography. As a key indicator of macro-textural irregularities, lower Rz values correspond to reduced skin unevenness.
Change in Facial Sagging (Mandibular Plane Angle)
Time frame: At Baseline, Week 2, Week 4, Week 8
Quantified by analyzing standard white-light photographs taken with a VISIA imaging system. The mandibular plane angle is measured in degrees (°) using image analysis software (Image-Pro Plus). An increase in the angle indicates a sharper, more defined, and firmer jawline contour.
2 secondary outcomes
Change in Skin Hydration
Time frame: At Baseline, Week 2, Week 4, Week 8
Change in Facial Transepidermal Water Loss (TEWL)
Time frame: At Baseline, Week 2, Week 4, Week 8
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 11 Feb 2026.
- Individual participant dataSharing planned: Yes
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 Face-and-Neck Cream (with 0.05% Vitamin K2) in people with Skin Aging of Face and Neck, run by Nanjing Ascend Biotech Technology Co., Ltd. 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 7 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 11 Feb 2026. 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. Some participants in this study may receive a placebo. 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 Facial Skin Elasticity (R0, R1 and F4) (time frame: At Baseline, Week 2, Week 4, and Week 8). The study lists 3 primary outcomes in all. 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 11 Feb 2026.