CLINICAL STUDY
Evaluation Of The Efficacy And Safety Of
Vibrant C-Serum On Addressing Skin Aging Concerns.
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.
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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.
INTRODUCTION
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.
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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.
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.
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
OUTCOME MEASURES
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.
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COMPLIANCE
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.
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STATISTICAL ANALYSIS
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
BEFORE & AFTER
©2023 CORE ENCHANTED ALL RIGHTS RESERVED.
©2023 CORE ENCHANTED ALL RIGHTS RESERVED.
©2023 CORE ENCHANTED ALL RIGHTS RESERVED.
RESULTS
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)
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*).
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SAFETY AND TOLERABILITY EVALUATIONS
No serious or non-serious adverse events were reported. Of the 32 subjects, 30 completed the study. 2 dropped out due to personal reasons.
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PATIENT REPORTED OUTCOMES
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.
DISCUSSION
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.
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