An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream

NCT ID: NCT04911374

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2021-02-03

Brief Summary

This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.

Detailed Description

This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the study.

Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.

A total of 42 subjects completed the study.

Conditions

Wrinkle; Photoaging; Fine Lines

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-Aging Face Moisturizer and Eye Cream

Dual Regimen:

1. Multi-ingredient anti-aging face moisturizer

2. Multi-ingredient anti-aging eye cream

Group Type: OTHER

Gentle Cleansing Lotion, Revision Skincare

Intervention Type: OTHER

Gentle cleansing lotion to be used by study participants

Aveeno Face Milk SPF 40+

Intervention Type: OTHER

Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day.

Interventions

Gentle Cleansing Lotion, Revision Skincare

Gentle cleansing lotion to be used by study participants

Intervention Type: OTHER

Aveeno Face Milk SPF 40+

Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women between the ages of 35 and 65 years
• Women with Fitzpatrick skin type I-VI
• Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate photodamage
• Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
• Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion Criteria

• Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face
• Subjects that had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
• Subjects that are unwilling to comply with the protocol
• Female subjects who are pregnant, breast feeding, or planning a pregnancy.
• Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
• Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
• Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
• Subjects who spend excessive time out in the sun.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Revision Skincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stephens and Associates

Richardson, Texas, United States

Countries

United States

Other Identifiers

C20-D134

Identifier Type: -

Identifier Source: org_study_id