A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area

February 20, 2024 updated by: Dime Beauty Co.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DIME Beauty Luminosity Eye Serum
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.
Other: DIME Beauty Luminosity Eye Serum
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
60 days
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.
60 days
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").
60 days
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").
60 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in appearance of fine lines and wrinkles in the eye area. [Baseline to Day 60]
Time Frame: 60 days
Measured via expert skin grading of before & after photos conducted by a board-certified dermatologist.
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
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").
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dime Beauty Co.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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