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

An Open-Label Clinical Study to Evaluate the Efficacy and Tolerability of a Multi-Ingredient Anti-aging Face Moisturizer and Eye Cream Targeting Aging

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.

Study Overview

• Status: Completed
• Conditions: Wrinkle; Photoaging; Fine Lines
• Intervention / Treatment: Other: Gentle Cleansing Lotion, Revision Skincare; Other: Aveeno Face Milk SPF 40+

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • Stephens and Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Anti-Aging Face Moisturizer and Eye Cream; Dual Regimen: Multi-ingredient anti-aging face moisturizer; Multi-ingredient anti-aging eye cream	Other: Gentle Cleansing Lotion, Revision Skincare; Gentle cleansing lotion to be used by study participants; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline	The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 in comparison to baseline indicates an improvement for the indicated parameter. The efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome.	12 weeks
Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline	The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example for Erythema: Erythema 0 = None No erythema of the treatment area; = Mild Slight, but definite redness of the treatment area; = Moderate Definite redness of the treatment area; = Severe Marked redness of the treatment area	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline	The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A change in scores or lack of significant change at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example Burning. 0 = None No burning of the treatment area; = Mild Slight burning sensation of the treatment area; not really bothersome; = Moderate Definite warm, burning of the treatment area that is somewhat bothersome.; = Severe Hot burning sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep	12 weeks
Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline	• Tewameter Measurements at baseline and weeks 4, 8, and 12. A change in Tewameter values reflects an improvement in the barrier properties of the skin; an absence of a change in treated skin indicates mildness of the applied treatment.	12 weeks
Stable skin pH during 12 week study	•pH Measurements at baseline and weeks 4, 8, and 12. A stable pH measurement reflects that the test product does not affect the overall cutaneous pH value.	12 weeks
Improvement in Epidermal Thickness after 12 weeks versus baseline	•OCT Imaging Procedures at baseline and week 12, with image analysis performed at the end of the study using images from baseline and week 12. A change in epidermal thickness indicates improvement.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Assessment Questionnaire	The secondary efficacy endpoints will be the Self-Assessment Questionnaire and the Subject Treatment Satisfaction and Ease of Use Questionnaire. A change in response values at week 4, week 8 and week 12 indicates an improvement compared to baseline response values. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement/ question being asked.	12 weeks

Collaborators and Investigators

• Sponsor: Revision Skincare

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): February 3, 2021

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: C20-D134

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No