A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum

NCT05514782 | Completed

• 1 other identifier: 8602
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a placebo-serum (vehicle control). A total of 62 subjects, 34-60 years of age completed study participation.

Conditions

Photoaging; Wrinkle

Keywords

anti-aging; daily serum

Outcome Measures

Primary Outcomes (2)

• Change In Clinical Efficacy Parameter Radiance Versus Baseline

  The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale at post-baseline timepoints. A decrease in scores at post-baseline timepoints (week 4,8, and12) 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

• Change in Active Cell versus Placebo Control in Clinical Efficacy at week 12

  The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale at post-baseline timepoints versus the placebo control. A confidence interval of 90% (p \<0.10) for both live clinical grading and photo-grading will be performed between the Cell 1 (active comparator) versus Cell 2 (placebo control comparator). 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

Secondary Outcomes (2)

• Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline

  12 weeks

• Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline

  12 weeks

Other Outcomes (3)

• Change In Facial parameters in a self-assessment questionnaire versus Baseline and % Agreement

  12 weeks

• Bioinstrumentation -Quantitative and Qualitative Data

  12 weeks

• Bioinstrumentation - Quantitative and Qualitative Data

  12 weeks

Study Arms (2)

Anti-Aging Daily Serum

ACTIVE COMPARATOR

Daily serum composed of a patent-pending botanical extract, bioavailable peptide, antioxidants, postbiotic(s), short term and long-term moisturizers. New product in development.

Other: Cleansing Lotion; Other: Facial Moisturizer; Other: Sunscreen SPF 40+

Placebo-Control

PLACEBO COMPARATOR

Vehicle control of the anti-aging daily serum.

Other: Cleansing Lotion; Other: Facial Moisturizer; Other: Sunscreen SPF 40+

Interventions

Cleansing Lotion OTHER

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

Also known as: Revision Skincare® Cleansing Lotion

Anti-Aging Daily Serum; Placebo-Control

Facial Moisturizer OTHER

Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.

Also known as: Goodier Cosmetics Facial Moisturizer

Anti-Aging Daily Serum; Placebo-Control

Sunscreen SPF 40+ OTHER

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

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

Anti-Aging Daily Serum; Placebo-Control

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
• KGL, Inc.: collaborator

Study Sites (1)

KGL Skin Study Center

West Chester, Pennsylvania, 19073, United States

Location

MeSH Terms

Interventions

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

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 KGL Skin prior to the start of the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, single-center

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 24, 2022
• Study Start: September 15, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)