Periorbital AreaNCT06143033
A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area
A study testing DIME Beauty Luminosity Eye Serum in people with Periorbital Area, run by Dime Beauty Co. at 1 site in United States.
Trial summary
This study will evaluate the efficacy of the DIME Beauty Luminosity Eye Serum in improving the appearance of skin in the periorbital eye area. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use the test products. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periorbital Area
- What is being tested?
- DIME Beauty Luminosity Eye Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 15 Feb 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females age 18-65.
- Have visible dark circles under the eyes.
- Have puffy eyes.
- Have bags under the eyes.
- Have visible fine lines and wrinkles around the eyes.
- Have a smartphone or camera to take before-and-after selfies.
Who cannot join
- Anyone not in good health.
- Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
- Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
- Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.
- Anyone who cannot/ will not commit to the study protocol.
- Anyone with a history of substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the efficacy of the DIME Beauty Luminosity Eye Serum in improving the appearance of skin in the periorbital eye area. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 30, and Day 60, photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.
- Conditions
- Periorbital Area
- Being tested
- DIME Beauty Luminosity Eye Serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIME Beauty Luminosity Eye SerumOther
Test product contains: Water/Aqua, Organic Aloe Vera Juice, Lycium Barbarum (Goji Berry) Fruit Extract, Vitis Vinifera (Grape Seed) Extract, Cucumis Sativus (Cucumber) Extract, Glycerin, Niacinamide, Squalane, Camellia Seed Oil, DL-Panthenol (Vitamin B5), Carbomer, Sodium Hyaluronate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethenol, Caprylyl Glycol, Acacia Senegal Gum, Caffeine, Helianthus Annuus (Sunflower) Seed Oil, Malus Domestica (Apple) Fruit Stem Cell Extract, Argania Spinosa (Argan) Sprout Stem Cell Extract, Tetrahexyldecyl Ascorbate (Vitamin C), Acetyl Tetrapeptide, Acetyl Hexapeptide-8, Vitamin E Mixed Tocopherols, Sodium Hydroxide.
| Study group | Role | What they receive |
|---|---|---|
| DIME Beauty Luminosity Eye Serum | Experimental | Participants will use the serum twice daily after their morning and evening skincare routine (i.e., after cleansing, and applying facial serums and moisturizers), but before the application of sunscreen. Receives: Other: DIME Beauty Luminosity Eye Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in appearance of periorbital puffiness. [Baseline to Day 60]
Measured via expert skin grading of before \& after photos conducted by a board-certified dermatologist.
Measured: 60 days
Change in appearance of dark circles underneath eyes. [Baseline to Day 60]
Measured via expert skin grading of before \& after photos conducted by a board-certified dermatologist.
Measured: 60 days
Change in participants' perception of the appearance of periorbital puffiness. [Baseline to Day 60]
Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: 60 days
Change in participants' perception of the appearance of dark circles underneath eyes. [Baseline to Day 60]
Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: 60 days
Secondary outcomes (2)
Change in appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]
Measured via expert skin grading of before \& after photos conducted by a board-certified dermatologist.
Measured: 60 days
Change in participants' perception of the appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]
Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start21 Aug 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital AreaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dime Beauty Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143033
- Sponsor's protocol ID
- 20363
- Status last verified
- Feb 2024
- First submitted
- 5 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area
- ClinicalTrials.gov ID
- NCT06143033
- Acronym / sponsor ID
- 20363
- Conditions
- Periorbital Area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dime Beauty Co.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 22 Nov 2023 (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.
This study will evaluate the efficacy of the DIME Beauty Luminosity Eye Serum in improving the appearance of skin in the periorbital eye area. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 30, and Day 60, photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DIME Beauty Luminosity Eye Serum | Experimental | Other: DIME Beauty Luminosity Eye SerumParticipants will use the serum twice daily after their morning and evening skincare routine (i.e., after cleansing, and applying facial serums and moisturizers), but before the application of sunscreen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females age 18-65.
- Have visible dark circles under the eyes.
- Have puffy eyes.
- Have bags under the eyes.
- Have visible fine lines and wrinkles around the eyes.
Key exclusion criteria (6 listed)
- Anyone not in good health.
- Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
- Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
- Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.
- Anyone who cannot/ will not commit to the study protocol.
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 |
|---|---|---|
| DIME Beauty Luminosity Eye SerumTest product contains: Water/Aqua, Organic Aloe Vera Juice, Lycium Barbarum (Goji Berry) Fruit Extract, Vitis Vinifera (Grape Seed) Extract, Cucumis Sativus (Cucumber) Extract, Glycerin, Niacinamide, Squalane, Camellia Seed Oil, DL-Panthenol (Vitamin B5), Carbomer, Sodium Hyaluronate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethenol, Caprylyl Glycol, Acacia Senegal Gum, Caffeine, Helianthus Annuus (Sunflower) Seed Oil, Malus Domestica (Apple) Fruit Stem Cell Extract, Argania Spinosa (Argan) Sprout Stem Cell Extract, Tetrahexyldecyl Ascorbate (Vitamin C), Acetyl Tetrapeptide, Acetyl Hexapeptide-8, Vitamin E Mixed Tocopherols, Sodium Hydroxide. | Other | DIME Beauty Luminosity Eye Serum |
Primary outcome
Change in appearance of periorbital puffiness. [Baseline to Day 60]
Time frame: 60 days
Measured via expert skin grading of before \& after photos conducted by a board-certified dermatologist.
Change in appearance of dark circles underneath eyes. [Baseline to Day 60]
Time frame: 60 days
Measured via expert skin grading of before \& after photos conducted by a board-certified dermatologist.
Change in participants' perception of the appearance of periorbital puffiness. [Baseline to Day 60]
Time frame: 60 days
Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Change in participants' perception of the appearance of dark circles underneath eyes. [Baseline to Day 60]
Time frame: 60 days
Measured via study-specific surveys. Surveys will be completed by participants and are designed using a 5-point Likert scale, with th 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
2 secondary outcomes
Change in appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]
Time frame: 60 days
Change in participants' perception of the appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]
Time frame: 60 days
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 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Periorbital Area
Active, not recruiting
Research on the Evolution, Geometry, and Alterations of the Periorbital Region Based on Age and Deformations
Facial Skin, Motion Capture
Enrolling by invitation
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
Periorbital Wrinkles, Periorbital Area
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 DIME Beauty Luminosity Eye Serum in people with Periorbital Area, run by Dime Beauty Co. at 1 site in United States.
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 6 inclusion and 6 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 22 Feb 2024. 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 United States. 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 appearance of periorbital puffiness. [Baseline to Day 60] (time frame: 60 days). The study lists 4 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 22 Feb 2024.