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

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: Completed
• Conditions: Periorbital Area
• Intervention / Treatment: Other: DIME Beauty Luminosity Eye Serum

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	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.	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").	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").	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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").	60 days

Collaborators and Investigators

• Sponsor: Dime Beauty Co.
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID 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