Background: The number of dermatology appointments aimed at preventing and treating aging skin is on the rise. The emergence of aging skin can have a significant impact on one’s quality of life. As we age, our skin undergoes various changes, such as the loss of collagen and elastin, decreased cell turnover, pigmentary changes and the appearance of wrinkles and sagging skin. These changes can affect both our physical and psychological well-being.1 A facial serum was developed with a novel combination of ingredients associated with an improvement in the appearance of fine lines and wrinkles, loss of firmness, loss of elasticity, skin tone, and skin brightness including Vitamin C (Tetrahexyldecyl ascorbate), Lilac Leaf Cell Culture Extract, Undaria Pinnatifida Extract, and Alaria Esculenta Extract.
Objective: To evaluate the efficacy and safety of a vitamin C and botanical extract facial serum on improving the appearance of fine lines and wrinkles, skin tone, skin brightness, skin texture, skin smoothness, skin elasticity, and skin firmness over 8 weeks
Methods: The study employed a single-center, monadic design with 32 healthy female subjects aged between 35 and 60 years, having various skin types (Fitzpatrick 1-4). Subjects applied the test product twice daily for 8 weeks. Clinical assessments were conducted at baseline, and at weeks 2, 4, and 8. The assessments included visual grading, skin firmness and elasticity measurements using Cutometer, and self-perception questionnaires.
Results: The study results demonstrated statistically significant improvements in all visual grading assessments, including skin texture, global fine lines/ wrinkles, skin brightness, and skin tone, at all-time points compared to baseline (p<0.0001). The test article also showed statistically significant improvements in skin firmness and skin elasticity at weeks 2, 4, and 8, compared to baseline (p<0.0001). The self-perception questionnaires revealed high favorability scores for most attributes (above 80%) except for three questions, which had a majority preference (above 50%).
Conclusion: This study demonstrates the facial serum may be effective and well-tolerated when treating and improving the visible effects of facial aging. Significant improvements were seen with all grading parameters as early as two weeks of usage. These results support the efficacy of the facial serum in addressing skin aging concerns.
Aging skin represents one of the most prevalent dermatological concerns worldwide, prompting continuous scientific efforts towards developing efficacious and safe interventions. Characterized by wrinkling, sagging, loss of elasticity, and uneven pigmentation, skin aging is an intricate process influenced by both intrinsic (genetic, metabolic, and cellular factors) and extrinsic (UV radiation, environmental pollution) factors. Current cosmetic interventions focus on various approaches including hydration, inflammation control, UV protection, and antioxidant usage, which aim to slow down the aging process or ameliorate its visible signs.2
The present study introduces a novel facial serum, innovatively combining Tetrahexyldecyl Ascorbate (THD Ascorbate), lilac leaf cell culture extract, Undaria Pinnatifida extract, and Alaric esculenta extract. THD Ascorbate, an oil-soluble derivative of Vitamin C, has been recognized for its superior skin penetration abilities and potent antioxidant properties. Furthermore, it promotes collagen production, assisting in maintaining the skin’s structural integrity, thereby targeting wrinkles and sagging.3
In parallel, the lilac leaf cell culture extract, derived from Syringa vulgaris (common lilac), carries anti-inflammatory and antioxidant benefits. It has shown promise in reducing pro-inflammatory mediators, making it a potential ally against aging-related changes.4,5 Undaria Pinnatifida extract, derived from a type of brown seaweed, is rich in minerals, antioxidants, and bioactive compounds such as fucoidan, known to exhibit anti-aging effects through its antioxidant, anti-inflammatory, and collagen-boosting properties. Alaria esculenta extract, derived from another variant of brown seaweed, is a source of vitamins and antioxidants, and has been shown to down-regulate the Progerin production of aged cells.6,7
Collectively, the facial serum’s unique formulation offers a comprehensive, multifaceted approach to skin aging, marrying the traditionally known botanical benefits with advanced scientific knowledge. This study evaluates the safety and efficacy of this novel combination serum, with an anticipation to provide a breakthrough in managing skin aging concerns.
Study Design And Participants
This was a monadic single-blind, single-center, home-use design study conducted over an 8-week use period. A total of 32 healthy female subjects aged 35 to 60 years were enrolled in the study, with most representation in the 40s age group. Subjects with all skin types (Fitzpatrick Skin Types I-IV) were included
Subjects were screened and enrolled in accordance to the inclusion and exclusion criteria described in Table 1. Table 2 provides a summary of demographic information.
During the study, participants were instructed to apply the test article twice daily, both in the morning and evening, to their face and neck. Participants were instructed not to introduce any new skincare products such as cleansers or cosmetics to their face, not to apply any other skincare products on their face, with the exception of their regular cleanser, sunscreen, and lip product (provided it did not contain active ingredients with anti-aging properties), and to take measures to protect their face from excessive sun exposure, either by limiting their time in the sun or wearing sunscreen, during the study.
Inclusion and Exclusion Criteria
| Inclusion Criteria | |||
|---|---|---|---|
| Healthy females aged 35-60 years of age. Attempt will be made to have most representation in the 40’s. | Willing to come to the facility for all visits with a clean face - no moisturizer or cosmetics or eye makeup or test article | ||
| All skin types (with majority Fitzpatrick Skin Types I-IV ) | Subject agrees to limit sun exposure to the face and agrees to use a facial sunscreen when out in the sun | ||
| Willing to follow study instructions and available to attend the study visits. | Willing to discontinue use of any products that have anti-aging benefits. | ||
| Provide written Informed Consent | Score ≥2 overall for fine lines in crow’s feet area, periorbital wrinkles, and uneven skin tone at the baseline visit | ||
| Exclusion criteria | |||
|---|---|---|---|
| Subject has a known allergy or hypersensitivity to facial serum products or similar materials or their ingredients (see INCI list) | Cosmetic medical procedures in the test area such as injectable anti-wrinkle products, facial cosmetic surgery, etc. in the last year | ||
| Self-reported pregnant or breast feeding or planning to become pregnant during the course of the study | Connective tissue disease or disorder such as scleroderma, cutis laxa, etc | ||
| Any conditions on the face that would interfere with evaluations (i.e. tattoos, scars, open cuts, sunburn, piercings, excessive hair, etc.) | Immune deficiency such as Lupus, HIV, AIDS | ||
| Facial chemical peel in the last 14 days | History of malignant disease | ||
| Medical condition which, in the opinion of the Investigator, would compromise the safety of the subject or confound study results | Use of self-tanning lotion on the face, within one-week prior to the start of the study | ||
| Concurrent medication that might affect the response to the test articles including routine use of anti-inflammatory medications, antihistamines, and steroids | |||
Summary of Demographic Information
| All Subject (N= 32) | |
| Age | |
| N | 32 |
| Mean | 42.8 |
| Standard Deviation | 6.8 |
| Median | 41.5 |
| Range | 34.0 to 60.0 |
| Gender - n (%) | |
| Female | 32 ( 100) |
| Fitzpatrick Skin Type - n (%) | |
| 1-Always burns easily,never tans | 7 (21.9) |
| 2-Always burns easily, tans minimally | 11 (34.4) |
| 3-Burns moderately, tans gradually | 6 (18.8) |
| 4-Burns minimally, always tans well | 8 (25.0) |
| Skin Type - n (%) | |
| Normal | 6 (18.8) |
| Oily | 7 (21.9) |
| Dry | 9 (28.1) |
| Combination | 10 (31.3) |
Clinical grading assessment of skin tone, skin brightness, and global fine lines and wrinkles was conducted by the clinical grader prior to application of the test article (baseline), week 2, week 4, and week 8. Skin Tactile assessments for texture/roughness were performed at baseline, week 2, week 4, and week 8. The Cutometer® (Courage + Khazaka; Koln, Germany) was used to measure elasticity (R2) and firmness (R0). One measurement was taken from the right crow’s feet area and one measurement from the left cheek area. Measuring mode 1 was used with constant suction of 400 mbar for five seconds followed by relaxation time of 3 seconds with three repetitions. Measurements were taken at baseline, and on weeks 2, 4 and 8. Subjects completed a Self-Perception Questionnaire (SPQ) to gauge the subject’s perception of the test article at weeks 2, 4 and 8. Subjects determined their level of agreement to statements about the test article utilizing a five-point Likert scale.
Participants in the study maintained a daily journal, documenting the application of test materials, any adverse events experienced, and their comments. Compliance with these entries was assessed during each follow-up visit after the initial assessment. The volume of facial serum provided for the study was visually examined during each follow-up visit to ensure adherence to the treatment regimen.
The descriptive statistical summary for instrumental and visual efficacy grading parameters includes N, mean, and standard deviation at all applicable time points. Analyses of the clinical grading consist of within treatment analyses on changes from baseline utilizing Wilcoxon’s Signed Rank Test. Analysis of the instrument data utilized paired t-tests on the changes from baseline.
Self-Perception Questionnaire responses were summarized specifying percent agreement for each SPQ statement (with Strongly Agree and Agree as the top box scores).
All statistical tests of hypothesis employed a level of significance of 0.05 and no adjustments were made for the number of tests performed.
Clinical Grading Of Efficacy Parameters
Statistically significant improvement for all visual grading assessment scores was shown from 2 weeks onward when compared to baseline. For skin texture, the mean difference from baseline was -1.0, -2.0, -2.8 with a % change mean -20.8%, -41.6%, -58.2% at weeks 2, 4, and 8 respectively (P=<.0001). For global fine lines and wrinkles, the mean differences from baseline was -1.0, -2.0, -2.833 with a % change mean -20.9%, -41.8%, -59.3% at weeks 2, 4, and 8 respectively (P<.0001*). For scores for skin brightness, the mean differences from baseline was -1.0, -2.0, -2.867 with a % change mean -20.4%, -40.8%, -58.4% at weeks 2, 4, and 8 respectively (P=<.0001). For skin tone, the mean differences from baseline was -1.031, -2.032, -2.833 with a % change mean -20.6%, -40.6%, -56.7% at weeks 2, 4, and 8 respectively (P=<.0001). (Figure 1)
Improvements across all visual efficacy parameters. Statistically significant improvements from baseline scores for skin texture, fine lines, brightness, and skin tone at weeks 2, 4, and 8.
A statistically significant increase in skin firmness was shown at all postbaseline time points (weeks 2, 4, and 8) when compared to baseline. The mean difference from baseline was 0.0692, 0.1615, 0.1786 with a % change mean 36.1%, 84.2%, 93.1% at weeks 2, 4, and 8 (P=0.0001*). A statistically significant increase in elasticity was shown at all post-baseline time points (weeks 2, 4, and 8) when compared to baseline. The mean difference from baseline was 0.1057, 0.1946, 0.2138 with a % change mean 27.4%, 50.4%, 55.4% at weeks 2, 4, and 8 (P=0.0001*).
No serious or non-serious adverse events were reported. Of the 32 subjects, 30 completed the study. 2 dropped out due to personal reasons.
Analysis of the self-perception questionnaires on product performance of the facial serum completed by subjects at each post-baseline time point revealed that all inquiries listed in Table 3 showed a majority preference (>50%) at week 2, week 4, and week 8, unless otherwise indicated. The test article performed highly favorable (>80%) in all but three questions (questions 5, 10 and 11) at week 8.
Analysis of Self-Perception Questionnaires
| 1 | My skin appears firmer. | 12 | This product calms the appearance of my skin redness. |
| 2 | Improved the appearance of my skin’s elasticity. | 13 | My skin texture feels softer. |
| 3 | My skin appears more radiant. | 14 | My skin looks softer |
| 4 | My skin appears brighter. | 15 | My skin feels silky after using this product. |
| 5 | My dark spots look lighter. | 16 | My skin looks more youthful. |
| 6 | My skin looks more hydrated. | 17 | This product improves the overall appearance of my skin. |
| 7 | My skin looks smoother. | 18 | I have gotten more compliments on my skin since using this product. (Statistically significant weeks 4 and 8 only) |
| 8 | This product lessens the appearance of my fine lines. | 19 | I rank this serum as excellent for my skin. |
| 9 | This product lessens the appearance of my wrinkles. | 20 | This product absorbs quickly. |
| 10 | This product lessens the appearance of my nose to mouth lines. | 21 | This product feels comfortable on my skin. |
| 11 | My pores appear smaller. | 22 | I would continue to use this product. |
The study provides compelling evidence that the facial serum with its unique combination of ingredients can effectively and safely address the visible signs of facial aging. Remarkably, the majority of subjects displayed statistically significant improvement within 2 weeks across all clinical parameters. The statistically significant improvements observed in skin texture, fine lines, wrinkles, brightness, tone, firmness, and elasticity, coupled with high favorability scores from the participants, indicate the potential of this facial serum as a promising intervention for individuals seeking to improve the appearance of their aging skin. It is also notable that subjects demonstrated continued improvement across all clinical parameters throughout the duration of the study, indicating that continued use yields continued aesthetic improvements. The combination of traditional botanical benefits and advanced scientific knowledge presents a valuable contribution to the field of dermatology. However, further research with a larger and more diverse sample, and longer follow-up periods, would be beneficial to validate and extend these findings. Overall, this study opens avenues for future investigations and potentially supports the development of novel and effective interventions for managing skin aging concerns.
Before
Immediately After
Before: Notice the appearance of dull skin
After: Skin appears brighter and smoother with an overall improvement in skin luminosity.
Findings: Skin appears more hydrated and radiant.
Before
Immediately After
Before: Notice the appearance of her under eye wrinkles.
After: Skin texture and undereye area appears smoother and brighter.
Findings: Improvement in lines & wrinkles, skin texture, and increase in hydration.
Before
2 Weeks After
Before: Notice the appearance of her under eye wrinkles.
After: Skin texture is smoother and undereye lines are less visible.
Findings: Improvement in lines & wrinkles, skin texture, increase in hydration.
Before
2 Weeks Afterr
Before: Notice the appearance of nasolabial folds.
After: Improvement in the noseto-mouth lines (nasolabial folds).
Findings: Improvement in fine lines & wrinkles.
Before
2 Weeks After
Before: Notice The Appearance Of Her Under Eye Wrinkles’ Skin Texture.
After: Skin texture is smoother and fine lines are less visible.
Findings: Improvement in lines & wrinkles, skin texture, increase in hydration and skin brightening.
Before
2 Weeks After
Before: Notice the appearance of marionette lines.
After: Improvement in the lines that run from corner of the mouth to the chin (marionette lines).
Findings: Improvement in fine lines & wrinkles.
Before
2 Weeks After
Before: Notice the appearance of dull skin and discoloration.
After: Skin appears brighter, more even toned, and radiant.
Findings: Improvement skin texture, increase in hydration and skin brightening.
Before
2 Weeks After
Before: Notice the appearance in skin texture.
After: Neck appears smoother with the lessening of the appearance of horizontal neck lines.
Findings: Improvement in lines, wrinkles and skin texture.
Before
2 Weeks After
Before: Notice the appearance in skin texture and brown spots.
After: Skin appears smoother, brighter, and more even toned.
Findings: Improvement in skin brightness, skin texture and fine lines and winkles.
Before
2 Weeks After
Before: Notice the appearance in skin texture and dullness.
After: Skin appears brighter and smoother with overall increase in luminosity.
Findings: Improvement in skin brightness, textures and winkles.
Before
Immediately After
Before: Notice the appearance in forehead lines.
After: : Improvement in forehead lines.
Findings: Improvement fine lines & wrinkles, specifically forehead lines, improvement in skin texture, and an increase in skin elasticity.
Before
Before: Notice the appearance of undereye wrinkles.
After: : Improvement in skin texture, and fine lines are less visible.
Findings: Improvement in lines, wrinkles, skin texture, and increase in skin hydration and brightness.
Immediately After
