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

Study Overview
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Brief Summary
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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.

Detailed Description
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This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 12-weeks days of twice-daily use when compared to the efficacy of a combination of a placebo-control (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, week 4, week 8, and week 12. 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 at baseline and post-baseline by a clinical grader, a board-certified dermatologist. Furthermore, blinded photo-grading at baseline and week 12 were performed by two board certified dermatologists. Self-assessment questionnaires, Antera 3D image, Ultrasound Imaging, and VISIA photography were completed at baseline and post-baseline timepoints. Furthermore, 10 randomized subjects, a subset of the study (five in Cell 1 and five in Cell 2) had 2 mm punch skin biopsies collected from the lateral, pre-auricular at baseline and week 12. A total of 62 subjects completed study participation (31 in Cell 1 and 31 in Cell 2).

Official Title
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Double-Blinded, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Tolerability of a Daily Serum

Conditions
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Photoaging, Wrinkle

Intervention / Treatment
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* Other: Cleansing Lotion
* Other: Facial Moisturizer
* Other: Sunscreen SPF 40+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blinded, placebo-controlled, single-center
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anti-Aging Daily Serum<br>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<br>* Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).<br>* Other names: Revision Skincare® Cleansing Lotion;Other: Facial Moisturizer<br>* Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.<br>* Other names: Goodier Cosmetics Facial Moisturizer;Other: Sunscreen SPF 40+<br>* 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<br>* Other names: Aveeno Positively Mineral Sensitive Skin SPF 40+);|
| Placebo Comparator: Placebo-Control<br>Vehicle control of the anti-aging daily serum. | Other: Cleansing Lotion<br>* Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).<br>* Other names: Revision Skincare® Cleansing Lotion;Other: Facial Moisturizer<br>* Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.<br>* Other names: Goodier Cosmetics Facial Moisturizer;Other: Sunscreen SPF 40+<br>* 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<br>* Other names: Aveeno Positively Mineral Sensitive Skin SPF 40+);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline | The second outcome measure is objective tolerability endpoint. Investigator Tolerability Assessment includes Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at week 4, 8, and 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 | 
| Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline | The secondary tolerability endpoint will be the Subjective Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase at week 4, 8, and 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-aging, daily serum