MedDataX Logo

A 12 Week Study to Evaluate the Efficacy of an Eye Cream

NCT ID: NCT05807620

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This single center, open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines and wrinkles. A total of 37 subjects were enrolled into the study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This single center, open-label clinical study was conducted to evaluate the efficacy and tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with Fitzpatrick Skin Type I - VI, and moderate to severe dark circles and under-eye puffiness. This study aims to evaluate the following objectives:

1. To evaluate the eye cream impact on undereye dark circles, undereye puffiness, fine lines and wrinkles periorbital eye area, and overall appearance periorbital eye area, as evaluated by investigator clinical grading, chromameter, VISIA clinical photography, and subjective questionnaire performed at baseline, week 4, week 8, and week 12.
2. To evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler performed at baseline, week 8, and week 12.
3. To assess objective and subjective tolerability of Dryness, Erythema, and Edema, and Burning, Stinging, Peeling, and Itching evaluated by investigator and subjective grading at baseline, week 4, week 8, and week 12.

A total of 37 subjects completed the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periorbital Hyperpigmentation Periorbital Edema Fine Lines Wrinkle

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

dark circles puffiness brightening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Eye Cream

Eye Cream composed of botanical extracts, bioavailable peptides, THD Ascorbate and Caffeine.

Subjects to apply a dime size amount onto the under-eye area and crow's feet area while avoiding direct eye contact twice daily for the duration of the 12-week clinical study.

Group Type EXPERIMENTAL

Gentle Cleansing Lotion

Intervention Type OTHER

Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).

Facial Moisturizer

Intervention Type OTHER

Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily).

Sunscreen SPF 30

Intervention Type OTHER

Neutrogena Ultra Sheer Dry Touch SPF 30. Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours.

Per FDA this intervention is an over the counter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gentle Cleansing Lotion

Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).

Intervention Type OTHER

Facial Moisturizer

Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen (morning and evening, 2x daily).

Intervention Type OTHER

Sunscreen SPF 30

Neutrogena Ultra Sheer Dry Touch SPF 30. Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours.

Per FDA this intervention is an over the counter

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Females in good general health
* With Fitzpatrick Skin Type I - VI
* Moderate to severe under eye dark circles
* Moderate undereye puffiness
* Mild to moderate fine lines and wrinkles

Exclusion Criteria

* Subjects who have used retinol or eye cream / serum 7 days prior to study commencement
* Nursing, pregnant, or planning a pregnancy during this study
* Having a health condition and / or pre-existing or dormant dermatologic disease on the face
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Validated Claim Support

UNKNOWN

Sponsor Role collaborator

Revision Skincare

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna Hardy

Role: STUDY_DIRECTOR

Validated Claim Support

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Validated Claim Support, LLC

Teaneck, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CS211024

Identifier Type: -

Identifier Source: org_study_id