Dark Eye Circles (Periorbital Hyperpigmentation)NCT07881367
Vitamin K2 (35) (MK-7) Reduces Dark Eye Circles: a Mechanistic and Human Efficacy Study
A study testing MK-7 Eye Cream in people with Dark Eye Circles (Periorbital Hyperpigmentation), run by Nanjing Ascend Biotech Technology Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if an eye cream containing 0.05% Vitamin K2 (35) (MK-7) works to reduce vascular-type dark eye circles in women aged 20-60 years. It will also learn about the mechanism of action of MK-7 through laboratory studies. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dark Eye Circles (Periorbital Hyperpigmentation)
- What is being tested?
- MK-7 Eye Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2024to 4 Jul 2024
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects aged 20-60 years.
- Presence of vascular-type dark eye circles.
- Healthy at the time of testing.
- Willing to participate and sign informed consent.
- Able to complete the study requirements according to the protocol.
Who cannot join
- Women planning pregnancy, pregnant, lactating, or within 6 months postpartum.
- Individuals with severe systemic diseases, immunodeficiency, or autoimmune diseases.
- Individuals with allergic diseases or a history of cosmetic allergy within the past 1-2 years.
- Individuals with dermatological diseases in the test area or currently receiving medication.
- Individuals with a cold, flu, or other acute illness at the start of the study that may affect participation.
- Individuals currently participating in or having participated in another test on the test area within the last month.
- Individuals deemed unsuitable by a dermatologist.
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 learn if an eye cream containing 0.05% Vitamin K2 (35) (MK-7) works to reduce vascular-type dark eye circles in women aged 20-60 years. It will also learn about the mechanism of action of MK-7 through laboratory studies. The main questions it aims to answer are:
Does the MK-7 eye cream improve under-eye skin color (lightness (L*) and individual typology angle (ITA°)) after 4 weeks of use?
Read more
Does the MK-7 eye cream reduce under-eye melanin content after 4 weeks of use?
Does the MK-7 eye cream perform better than a placebo eye cream in improving these parameters?
Researchers will compare the MK-7 eye cream applied to one eye area to a placebo eye cream (a look-alike substance that contains no MK-7) applied to the other eye area to see if the MK-7 eye cream works to reduce dark eye circles. This is a double-blind, split-face study, meaning each participant receives both products but neither the participants nor the assessors know which side received which product.
Participants will:
Apply the MK-7 eye cream to one eye area and the placebo eye cream to the other eye area twice daily for 4 weeks
Visit the clinic at baseline (T0), 2 weeks (T2w), and 4 weeks (T4w) for instrumental assessments, including VISIA imaging and Mexameter measurements
Be instructed not to apply any products to the designated test areas for 3-5 days before each assessment
Maintain their usual basic skincare routine (e.g., cleanser, toner) on areas outside the test sites
Provide informed consent before participating
- Being tested
- MK-7 Eye Cream, Placebo Eye Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-7 Eye CreamOther
Eye cream containing 0.05% Vitamin K2 (35) (MK-7). Applied topically to one randomly assigned eye area twice daily for 4 weeks.
Placebo Eye CreamOther
Eye cream without MK-7. Applied topically to the contralateral eye area twice daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MK-7 Eye Cream | Experimental | Eye cream containing 0.05% Vitamin K2 (35) (MK-7), applied twice daily to one randomly assigned eye area for 4 weeks. Receives: Other: MK-7 Eye Cream |
| Placebo Eye Cream | Placebo comparator | Eye cream without MK-7, applied twice daily to the contralateral eye area for 4 weeks. Receives: Other: Placebo Eye Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Individual Typology Angle (ITA°) of the under-eye area from baseline (T0) to Week 4 (T4w)
ITA° was derived from VISIA images analyzed using Image-Pro Plus software in the CIE Lab* color space. Higher ITA° values indicate lighter skin complexion. The primary comparison was between the MK-7 Eye Cream-treated side and the Placebo Eye Cream-treated side at T4w.
Measured: Baseline (T0) to Week 4 (T4w)
Secondary outcomes (3)
Change in L* value (lightness) of the under-eye area
L* was derived from VISIA images analyzed using Image-Pro Plus software in the CIE Lab* color space. L* ranges from 0 (black) to 100 (white), with higher values indicating brighter skin. Classified as a secondary, exploratory endpoint.
Measured: Baseline (T0) to Week 2 (T2w) and Week 4 (T4w)
Change in Melanin Index (MI) of the under-eye area
MI was measured by Mexameter, a reflectance-based device. Higher values indicate greater pigmentation/darker tone in the epidermis. Classified as a secondary, exploratory endpoint.
Measured: Baseline (T0) to Week 2 (T2w) and Week 4 (T4w)
Change in Individual Typology Angle (ITA°) of the under-eye area at Week 2
ITA° was derived from VISIA images analyzed using Image-Pro Plus software. The T2w assessment was a secondary, exploratory time point intended to characterize the onset of treatment effect.
Measured: Baseline (T0) to Week 2 (T2w)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start6 Jun 2024
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dark Eye Circles (Periorbital Hyperpigmentation)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 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
- NCT07881367
- Sponsor's protocol ID
- 2024-293-ZH-091
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Efficacy Testing
- ClinicalTrials.gov ID
- NCT07881367
- Acronym / sponsor ID
- 2024-293-ZH-091
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nanjing Ascend Biotech Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 19 Oct 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 learn if an eye cream containing 0.05% Vitamin K2 (35) (MK-7) works to reduce vascular-type dark eye circles in women aged 20-60 years. It will also learn about the mechanism of action of MK-7 through laboratory studies. The main questions it aims to answer are:
Does the MK-7 eye cream improve under-eye skin color (lightness (L*) and individual typology angle (ITA°)) after 4 weeks of use?
Does the MK-7 eye cream reduce under-eye melanin content after 4 weeks of use?
Does the MK-7 eye cream perform better than a placebo eye cream in improving these parameters?
Researchers will compare the MK-7 eye cream applied to one eye area to a placebo eye cream (a look-alike substance that contains no MK-7) applied to the other eye area to see if the MK-7 eye cream works to reduce dark eye circles. This is a double-blind, split-face study, meaning each participant receives both products but neither the participants nor the assessors know which side received which product.
Participants will:
Apply the MK-7 eye cream to one eye area and the placebo eye cream to the other eye area twice daily for 4 weeks
Visit the clinic at baseline (T0), 2 weeks (T2w), and 4 weeks (T4w) for instrumental assessments, including VISIA imaging and Mexameter measurements
Be instructed not to apply any products to the designated test areas for 3-5 days before each assessment
Maintain their usual basic skincare routine (e.g., cleanser, toner) on areas outside the test sites
Provide informed consent before participating
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-7 Eye Cream | Experimental | Other: MK-7 Eye CreamEye cream containing 0.05% Vitamin K2 (35) (MK-7), applied twice daily to one randomly assigned eye area for 4 weeks. |
| Placebo Eye Cream | Placebo comparator | Other: Placebo Eye CreamEye cream without MK-7, applied twice daily to the contralateral eye area for 4 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects aged 20-60 years.
- Presence of vascular-type dark eye circles.
- Healthy at the time of testing.
- Willing to participate and sign informed consent.
- Able to complete the study requirements according to the protocol.
Key exclusion criteria (7 listed)
- Women planning pregnancy, pregnant, lactating, or within 6 months postpartum.
- Individuals with severe systemic diseases, immunodeficiency, or autoimmune diseases.
- Individuals with allergic diseases or a history of cosmetic allergy within the past 1-2 years.
- Individuals with dermatological diseases in the test area or currently receiving medication.
- Individuals with a cold, flu, or other acute illness at the start of the study 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 |
|---|---|---|
| MK-7 Eye CreamEye cream containing 0.05% Vitamin K2 (35) (MK-7). Applied topically to one randomly assigned eye area twice daily for 4 weeks. | Other | MK-7 Eye Cream |
| Placebo Eye CreamEye cream without MK-7. Applied topically to the contralateral eye area twice daily for 4 weeks. | Other | Placebo Eye Cream |
Primary outcome
Change in Individual Typology Angle (ITA°) of the under-eye area from baseline (T0) to Week 4 (T4w)
Time frame: Baseline (T0) to Week 4 (T4w)
ITA° was derived from VISIA images analyzed using Image-Pro Plus software in the CIE Lab* color space. Higher ITA° values indicate lighter skin complexion. The primary comparison was between the MK-7 Eye Cream-treated side and the Placebo Eye Cream-treated side at T4w.
3 secondary outcomes
Change in L* value (lightness) of the under-eye area
Time frame: Baseline (T0) to Week 2 (T2w) and Week 4 (T4w)
Change in Melanin Index (MI) of the under-eye area
Time frame: Baseline (T0) to Week 2 (T2w) and Week 4 (T4w)
Change in Individual Typology Angle (ITA°) of the under-eye area at Week 2
Time frame: Baseline (T0) to Week 2 (T2w)
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 19 Oct 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 MK-7 Eye Cream in people with Dark Eye Circles (Periorbital Hyperpigmentation), 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 5 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 19 Oct 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 Individual Typology Angle (ITA°) of the under-eye area from baseline (T0) to Week 4 (T4w) (time frame: Baseline (T0) to Week 4 (T4w)). 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 19 Oct 2026.