A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum

A Double-blind, Randomized, Controlled Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum

This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer. A total of 26 female subjects, aged 34-60, completed study participation.

Study Overview

• Status: Completed
• Conditions: Wrinkle; Photoaging; Fine Lines
• Intervention / Treatment: Other: Anti-aging Serum; Other: Cleansing Lotion; Other: Sunscreen; Other: Sunscreen; Other: Facial Moisturizer

Detailed Description

This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer (Cell 2). Skin fatigue was characterized by dehydrated skin with a lack of firmness (visual) and a dull appearance on the global face.

Efficacy and tolerability were assessed through clinical grading at baseline, day 3, and day 7. Efficacy evaluation on fine lines and wrinkles in the crow's feet area; overall eye appearance on the periocular area; and smoothness (tactile), firmness (visual), radiance, and overall photodamage on the global face were performed 15 minutes post product application. Self-assessment questionnaires, Glossymeter measurements, and VISIA photography were completed at baseline, day 3, and day 7.

A total of 26 subjects completed study participation, which included 12 subjects in Cell 1, and 14 subjects in Cell 2.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • SGS Stephens, inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female, 30 to 60 years of age
• Fitzpatrick skin type I -IV
• Moderate overall photodamage of the skin
• Moderate lack of firmness (visual) of the skin
• Moderate dull appearance of the skin
• Subjects must be willing to withhold all facial treatments during the course of the study and have not undergone a treatment within the last 6 months
• Subject must be willing to provide verbal understanding and written informed consent

Exclusion Criteria:

• Diagnosed with known allergies to facial skincare products
• Nursing, pregnant, or planning to become during the duration of the study
• History of skin cancer within the past 5 years
• Having used oral isotretinoin within the last 12 months
• Having used prescription-strength skin-lightening products within the last 3 months
• Having used any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within the last 4 weeks
• Having a health condition and/or pre-existing or dermatologic disorder that, in the Investigator's opinion, may interfere with the outcome of the study
• Having observable sunburn, suntan, scars, excessive facial hair, or other dermal conditions on the face that, in the Investigator's opinion, may influence test results
• Having a history of immunosuppression/immune deficiency disorders, or currently using oral or systemic immunosuppressive medications and biologics, and/or undergoing radiation or chemotherapy
• Using or having regularly used systemic or topical corticosteroids within the past 4 weeks
• Having started a long-term medication within the last 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cell 1: Anti-aging Serum; Dosage form: Anti-aging Serum Frequency of Dosage: two times daily. Subjects are asked to apply 2 pumps of the Anti-aging Serum. Study Duration: 7 days	Other: Anti-aging Serum; Serum composed of a patent-pending botanical extract, bioavailable peptides, antioxidants, post-biotics, and short and long-term moisturizers; Other: Cleansing Lotion; Facial cleansing lotion to be used by study participants; Other Names: Revision Skincare® Cleansing Lotion; Other: Sunscreen; Sunscreen to be applied after application of serum in the morning. Participants were asked to reapply every 2 hours; Other Names: Aveeno Positively Mineral Sensitive Skin SPF 40+; Other: Sunscreen; Sunscreen to be applied after application of facial moisturizer in the morning. Participants were asked to reapply every 2 hours; Other Names: Aveeno Positively Mineral Sensitive Skin SPF 40+
Active Comparator: Cell 2: Anti-aging Serum and Facial Moisturizer; Dosage form: Anti-aging Serum and Facial Moisturizer Frequency of Dosage: two times daily. Subjects are asked to apply 2 pumps of the Anti-aging Serum, and then 2 pumps of the Facial Moisturizer to the global face. Study Duration: 7 days	Other: Anti-aging Serum; Serum composed of a patent-pending botanical extract, bioavailable peptides, antioxidants, post-biotics, and short and long-term moisturizers; Other: Cleansing Lotion; Facial cleansing lotion to be used by study participants; Other Names: Revision Skincare® Cleansing Lotion; Other: Sunscreen; Sunscreen to be applied after application of serum in the morning. Participants were asked to reapply every 2 hours; Other Names: Aveeno Positively Mineral Sensitive Skin SPF 40+; Other: Sunscreen; Sunscreen to be applied after application of facial moisturizer in the morning. Participants were asked to reapply every 2 hours; Other Names: Aveeno Positively Mineral Sensitive Skin SPF 40+; Other: Facial Moisturizer; Anti-aging facial moisturizer to be used by study participants after serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Grading of Efficacy Parameters	The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 3, and Day 7 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.	7 days
Tolerability Evaluations	The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at Day 3, and Day 7 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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritation Evaluation	The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase at Day 3, and Day 7 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	7 days
Self-assessment Questionnaire	The secondary efficacy endpoints will be the Self-Assessment Questionnaire and the Subject Treatment Satisfaction and Ease of Use Questionnaire. A decrease or increase in response values at Day 3, and Day 7 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.	7 days
Bioinstrumentation Measurements	The secondary efficacy endpoints will be the Glossymeter measurements. Measurements of the gloss of the skin, taken at Day 3 and Day 7 in comparison to baseline, will measure the white light, created by LEDs, directly reflected from the skin.	7 days
VISIA-CR Photography	VISIA-CR photography taken at Baseline, Day 3 and Day 7 with image analysis at the end of the study.	7 days

Collaborators and Investigators

• Sponsor: Revision Skincare
• Collaborators: Stephens & Associates, Inc.
• Investigators: Principal Investigator: Tanja Emmerich, PhD, SGS Stephens, inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): October 13, 2020
• Study Completion (Actual): October 13, 2020

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: anti-aging; serum
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: C20-D146

Drug and device information, study documents

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