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

NCT05271136 | Completed

• 1 other identifier: C20-D146
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fine Lines; Wrinkle; Photoaging

Keywords

anti-aging; serum

Outcome Measures

Primary Outcomes (2)

• 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 1. = Mild Slight, but definite redness of the treatment area 2. = Moderate Definite redness of the treatment area 3. = Severe Marked redness of the treatment area

  7 days

Secondary Outcomes (4)

• Irritation Evaluation

  7 days

• Self-assessment Questionnaire

  7 days

• Bioinstrumentation Measurements

  7 days

• VISIA-CR Photography

  7 days

Study Arms (2)

Cell 1: Anti-aging Serum

ACTIVE COMPARATOR

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; Other: Cleansing Lotion; Other: Sunscreen

Cell 2: Anti-aging Serum and Facial Moisturizer

ACTIVE COMPARATOR

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; Other: Facial Moisturizer; Other: Cleansing Lotion; Other: Sunscreen

Interventions

Anti-aging Serum OTHER

Serum composed of a patent-pending botanical extract, bioavailable peptides, antioxidants, post-biotics, and short and long-term moisturizers

Cell 1: Anti-aging Serum; Cell 2: Anti-aging Serum and Facial Moisturizer

Facial Moisturizer OTHER

Anti-aging facial moisturizer to be used by study participants after serum

Cell 2: Anti-aging Serum and Facial Moisturizer

Cleansing Lotion OTHER

Facial cleansing lotion to be used by study participants

Also known as: Revision Skincare® Cleansing Lotion

Cell 1: Anti-aging Serum; Cell 2: Anti-aging Serum and Facial Moisturizer

Sunscreen OTHER

Sunscreen to be applied after application of serum in the morning. Participants were asked to reapply every 2 hours

Also known as: Aveeno Positively Mineral Sensitive Skin SPF 40+

Cell 1: Anti-aging Serum

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revision Skincare: lead
• Stephens & Associates, Inc.: collaborator

Study Sites (1)

SGS Stephens, Inc.

Richardson, Texas, 75081, United States

Location

MeSH Terms

Interventions

cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion; Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Tanja Emmerich, PhD

  SGS Stephens, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization occurred by assignment to either Cell 1 or Cell 2 using a randomization list, prepared by Stephens prior to the start of the study. The list was first created by concatenating blocks of size of 4 subjects, 2 for Cell 1 and 2 for Cell 2. The list was then randomized by variables from 2 independent uniform distributions: one to randomize subjects within a block and one to randomized blocks. After the randomized list was created, treatment was assigned to each subject number accordingly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, controlled, single-center

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: March 8, 2022
• Study Start: September 30, 2020
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

US (1)