Efficacy of Cosmetic Products for the Periocular Area

Enhance Your Social Connections: The Importance of Eye Appearance

Your eyes, their gaze, and the overall appearance of the periocular area play a vital role in establishing and nurturing social relationships. The saying “the eyes are the window to the soul” encapsulates both the psychological and aesthetic significance of eye appearance. Eye contact during conversations conveys engagement and interest, making it evident that maintaining a youthful and attractive periocular area is crucial in the cosmetic industry. This emphasis on the eyes highlights their role in communication and personal interaction.

However, the aesthetic appeal of the periocular area is often compromised by various imperfections associated with both fatigue and aging. Common concerns such as under-eye bags, ¹ dark circles, ² and signs of aging³—including loss of elasticity and dehydration—are frequent issues faced by individuals striving to maintain a youthful appearance. These imperfections arise from a complex interplay of factors, with aging being a significant contributor.^4,5

Given the multifaceted nature of these imperfections, cosmetic practitioners and dermatologists have a wide array of treatment options available to address these concerns. Treatments such as botulinum toxin,⁶ hyaluronic acid fillers,^7,8 wavelength tunable laser devices, and fractionated laser therapy are popular choices. These methods aim to rejuvenate the periocular area and restore its youthful appearance.

Despite their effectiveness, these treatments can be costly, invasive, and may come with potential side effects. Additionally, many individuals may feel hesitant or intimidated by such approaches. Consequently, there is a growing demand for effective, non-invasive topical cosmetic treatments that can provide similar benefits without the drawbacks associated with more invasive procedures.

This clinical and instrumental study aimed to evaluate the efficacy and tolerability of a cosmetic product, specifically the Nutrakos Eye Contour Gel (Professional Dietetics S.p.A., Milano, Italy), which was developed to effectively target under-eye bags and dark circles while also offering anti-aging properties.

Research Methods and Study Design

Study Participants and Research Settings

This investigation was conducted as a monocentric, open-label study involving 40 healthy Caucasian females, all of whom were recruited by a board-certified dermatologist. Every procedure in this study adhered to the ethical guidelines set forth by the World Medical Association’s (WMA) Helsinki Declaration and its amendments (Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964, and its amendments). Each participant provided informed consent and permission for the publication of photographs prior to engaging in any study-related procedures. In compliance with Colipa (now Cosmetics Europe) guidelines, all ethical standards were maintained, and the test product underwent safety assessments before the study commenced.⁹ In accordance with EU cosmetic Regulation no. 1223/2009, a cosmetic product must not pose a risk to human health when applied under normal or foreseeable conditions of use, necessitating a safety evaluation before human exposure.

The study included adult females over the age of 40 exhibiting clinical signs of either under-eye bags and wrinkles in the periocular region (n = 20, 50% of participants) or dark circles and wrinkles (n = 20, 50% of participants). Participants were required to be in good health, free from any active skin conditions in the test area, and without a known history of atopic dermatitis or skin elastosis affecting the facial skin.

Exclusion criteria encompassed pregnancy or intent to become pregnant, breastfeeding, known allergies to cosmetics, sunscreen, or topical medications, as well as any unwillingness or inability to adhere to study protocols. Additionally, participants with dermatological issues in the test area or a history of hypersensitive skin were excluded.

During the study period, participants were instructed to avoid both natural and artificial UV exposure. They attended clinic visits at baseline and again after 28 days of product application.

The study was conducted at the Complife Italia Srl dermatological facility located in San Martino Siccomario, Pavia, Italy, from June to November 2021. Complife Italia is an independent testing laboratory collaborating with the University of Pavia, specializing in the in vitro and in vivo safety and efficacy assessment of cosmetics, food supplements, and medical devices.

Product Application Protocol

The product under evaluation was the Nutrakos Eye Contour Gel from Professional Dietetics S.p.A., Milano, Italy. Its formulation included AQUA, GLYCERIN, GLYCINE, SODIUM POLYACRYLATE, PROLINE, ALANINE, PEG-40 HYDROGENATED CASTOR OIL, PHENOXY-ETHANOL, VALINE, PEG/PPG-20/6 DIMETHICONE, CITRONELLYL METHYLCROTONATE, PROPYLENE GLYCOL, SODIUM HYALURONATE, PPG-26-BUTETH-26, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, POLYGLYCERYL-10 EICOSANEDI-OATE/TETRADECANEDIOATE, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, LEUCINE, ALBIZIA JULIBRISSIN BARK EXTRACT, LYSINE HCI, DISODIUM EDTA, PARFUM, DARUTOSIDE (SIEG-ESBECKIA ORIENTALIS EXTRACT).

Participants were instructed to apply the gel to the eye contour area twice daily, once in the morning and once in the evening, following cleansing. A gentle massage was encouraged to promote optimal product absorption.

Key Metrics and Outcomes for Efficacy Evaluation

The primary efficacy endpoint focused on the product’s ability to reduce the appearance of under-eye bags and dark circles. Key outcomes included measuring the volume of bags under the eyes and the color characteristics of dark circles.

Secondary efficacy endpoints evaluated the product’s influence on skin texture, including wrinkle depth, skin smoothness, skin hydration, radiance, and elasticity. Secondary outcomes included an assessment of wrinkle depth, skin smoothness, hydration levels, radiance, and elasticity. These instrumental measurements were supplemented by clinical assessments from dermatologists and self-assessment questionnaires completed by participants.

All measurements were taken on bare skin under controlled temperature (21±1°C) and humidity (50±10%) conditions. Participants were allowed to acclimate to the room conditions for 15 to 20 minutes before starting the evaluations.

Assessing Under-Eye Bags, Skin Texture, and Dark Circles

The volume of under-eye bags, along with skin smoothness (Sa parameter) and maximum wrinkle depth, were evaluated using a real 3D camera (Primos^CR SF, Canfield Scientific, NJ, USA). This device enables measurement of skin structure volume and surface characteristics through structured light projection. The parameters for skin smoothness and maximum wrinkle depth were specifically assessed in the periocular area, commonly referred to as the “crow’s feet” region.

The color of dark circles was analyzed in the CIELab chromatic space utilizing a spectrophotometer/colorimeter CM-700D (Konica-Minolta, Japan).¹⁰ The a* (red) and b* (blue) components of dark circles were measured to determine color changes.

Evaluating Skin Moisture Levels

The superficial skin moisture content (10–20 mm) was assessed using a Corneometer^® CM 825 (Courage + Khazaka, electronic GmbH, Cologne, Germany).¹¹ This instrument gauges variations in skin capacitance, reflecting the skin’s moisture content accurately.

Assessing Skin Elasticity

Skin elasticity measurements were conducted using a Cutometer^® MPA 580 (Courage + Khazaka, electronic GmbH, Cologne, Germany).¹² This assessment evaluated R0 (skin firmness) and R2 (overall elasticity), both vital indicators of skin health.

Measuring Skin Radiance and Brightness

The skin’s radiance, often referred to as brightness, was evaluated with a spectrophotometer/colorimeter CM-700D (Konica-Minolta, Japan). The primary parameter assessed was the 8° gloss measurement, which indicates the reflective quality of the skin.

Clinical Assessment of Skin Condition

The dermatologist assessed the reduction in skin wrinkledness in the periocular area, along with the visibility of under-eye bags and dark circles, utilizing a clinical scoring system detailed in Table 1.

Table 1 Clinical Scoring System Overview

Participant Feedback through Self-Assessment

<pUpon completion of the study, participants provided feedback on the tested product via a self-assessment questionnaire. The items evaluated included: 1) effectiveness in reducing under-eye puffiness, 2) reduction in dark circle coloration, 3) decrease in visibility of fine lines and wrinkles, 4) improvement in skin brightness, 5) enhancement of skin firmness, 6) skin moisturization improvements, 7) smoothing effects, 8) reduction in signs of fatigue, 9) texture perception, 10) absorption rate, 11) ease of application, 12) overall satisfaction, 13) likelihood to purchase, and 14) product tolerability. Items 1 to 11 were rated as “Completely agree,” “Agree,” “Disagree,” or “Completely disagree,” while responses to items 12 to 14 were categorized as “Yes” or “No.”

Statistical Analysis Methodology

Statistical analyses were performed utilizing a Microsoft^® Excel^® worksheet (Microsoft 365 Apps for enterprise, version 2202, build 14931.20132) on a Microsoft^® Windows^® 11 Pro 64-bit edition (version 10.0.22000, build 22000). The statistical analysis employed a two-way t test as per Student’s method, with a significance threshold set at p < 0.05. Statistical outputs were reported with indications of significance: *p < 0.05, p < 0.01, and <b>*p < 0.001.</p>
<h2>Study Findings and Results</h2>
<h3>Participant Demographics and Product Tolerability</h3>
<p>A total of 40 female subjects participated in the study, attending clinic visits at baseline (D0) and after 28 days (D28) of using the product. All enrolled subjects (n = 20 in the under-eye bags and wrinkles group and n = 20 in the dark circles and wrinkles group) completed the study without any dropouts or missing results. Detailed demographics and clinical characteristics of the participants are provided in Table 2.</p>
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<p class="tabtext"><strong>Table 2</strong> Overview of Subjects’ Baseline Demographic and Clinical Characteristics</p>
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<p>The product demonstrated excellent tolerability, with no local reactions reported, whether physical (objective reactions) or functional (subjective responses) from either the ophthalmologist or the participants.</p>
<h3>Primary Efficacy Outcomes: Volume of Under-Eye Bags and Dark Circles</h3>
<p>The primary efficacy endpoints concerning the product’s effectiveness were assessed through image analysis of real 3D images and colorimetric evaluation. The results are summarized in Figure 2.</p>
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<p class="tabtext"><strong>Figure 2</strong> (<strong>A</strong>) Results for volume of under-eye bags. (<strong>B</strong>) Results for dark circles color (a*, red component). (<strong>C</strong>) Results for dark circles color (b*, blue component). Data are presented as averages (± standard error). Statistical analysis (D28 vs D0) is indicated above the bar: <b> p<0.01. au = arbitrary units. D0 = baseline. D28 = follow-up visit after 28 days of product application.</p>
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<p>After 28 days of product use, the volume of under-eye bags significantly decreased (p<0.01), with an average reduction of 6.8% (minimum +6.1%; maximum −25.9%). This instrumentally measured outcome was also corroborated by dermatologist observations, with 60% of participants showing noticeable improvement (Figure 3B).</p>
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<p class="tabtext"><strong>Figure 3</strong> (<strong>A</strong>) Visual assessment of periocular wrinkles (standard general white lighting). (<strong>B</strong>) Results for volume of under-eye bags (standard general white lighting). (<strong>C</strong>) Assessment of dark circles color (cross-polarized filter).</p>
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<p>The a* (red) and b* (blue) components of the typical purplish hue of dark circles were analyzed through colorimetric methods. The red (a*) component exhibited a significant reduction (p<0.01) after 28 days of product application (Figure 2B), with an average decrease of 7.1% (minimum −20.7%; maximum 7.7%). Conversely, the blue (b*) component showed a significant increase (p<0.01) post-application (Figure 2C), with a mean increase of 4.0% (minimum −4.9%; maximum 12.2%). The concurrent decrease in the a* parameter alongside the increase in the b* parameter signifies a reduction in the purplish color characteristic of dark circles. This finding was also observed by dermatologists in 55% of study participants (Figure 3C).</p>
<h3>Secondary Efficacy Outcomes</h3>
<h4>Reduction in Wrinkle Depth and Enhanced Skin Smoothness</h4>
<p>The reduction in wrinkle depth and improvement in skin smoothness were assessed through structured light projection using the real 3D camera (PrimosCR, Canfield Scientific). Results are summarized in Table 3.</p>
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<p class="tabtext"><strong>Table 3</strong> Summary of Secondary Endpoint Results</p>
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<p>Following 28 days of product use, the depth of periocular wrinkles (“crow’s feet” wrinkles) significantly decreased (p<0.01), with an average reduction of 15.8% (minimum +8.1%; maximum −38.9%). This improvement was categorized as “mild improvement” by dermatologists for 70% of participants (Figure 3A).</p>
<p>Skin smoothness in the periocular area was assessed through Sa parameter analysis. Sa, which extends Ra (the arithmetic mean height of a line) to a surface, represents the average deviation of profile height from the mean surface, effectively measuring surface roughness. After 28 days of product application, the Sa parameter significantly decreased (p<0.05), showing a mean reduction of 6.3% (minimum +11.5%; maximum −25.6%). This reduction in Sa reflects an enhancement in skin smoothness, aligning with the anti-aging and anti-wrinkle properties attributed to the tested product.</p>
<h3>Enhancements in Skin Moisturization</h3>
<p>The skin’s moisture content, as recorded in Table 2, exhibited a significant increase (p<0.001) after 28 days of product use, with an average improvement of 11.7% (minimum −4.0%; maximum +26.0%).</p>
<h3>Improvements in Skin Elasticity</h3>
<p>Skin elasticity was evaluated through assessments of both maximum distensibility (R0 parameter) and the ratio of maximum skin deformation to its return to baseline (R2, overall elasticity). The data are presented in Table 2.</p>
<p>After 28 days of product use, the skin distensibility notably decreased (p<0.001) with an average increase of 8.9% (minimum +5.4%; maximum −26.1%). A reduction in the R0 parameter indicates enhanced skin firmness.</p>
<p>Moreover, the overall elasticity of the skin demonstrated a significant increase (p<0.001) after 28 days of product application, with a mean improvement of 10.4% (minimum −2.2%; maximum +29.5%). This increase in the R2 parameter is indicative of improved function of the skin’s elastic fibers.</p>
<h3>Enhancements in Skin Radiance</h3>
<p>Skin radiance, as noted in Table 2, significantly improved (p<0.001) after 28 days of using the product, with an average increase of 16.3% (minimum −10.1%; maximum +44.1%). This enhancement in skin radiance can be attributed to improved microcirculation and anti-aging effects.</p>
<h3>Participant Feedback from Self-Assessment</h3>
<p>Overall, the product was rated as effective and pleasant by the majority of participants in the study. The comprehensive results from the self-assessment questionnaire are detailed in Table 4.</p>
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<p class="tabtext"><strong>Table 4</strong> Summary of Self-Assessment Questionnaire Results: Percentage of Subjects Providing Specific Responses</p>
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<h2>Insights and Implications of the Study</h2>
<p>The appearance and overall wellness of the periocular area are often compromised by various imperfections linked to fatigue and aging.^1–3 Various aesthetic treatments have demonstrated effectiveness in enhancing the appearance of the periocular region.^4,6–8 However, many individuals are hesitant to pursue these options due to concerns about invasiveness, potential side effects, and costs associated with these treatments.</p>
<p>This study aimed to investigate the efficacy of a cosmetic product in addressing under-eye bags, dark circles, and signs of aging through both instrumental and clinical methodologies.</p>
<p>The findings indicate that the product effectively enhances the aesthetics of the periocular area by reducing the visibility of under-eye bags and improving the color of dark circles. Additionally, improvements in skin hydration and elasticity contribute to reductions in “crow’s feet” wrinkles while promoting skin smoothness. Notably, these benefits were not only instrumentally measured but also visually confirmed by the dermatologist’s evaluations.</p>
<p>Participant satisfaction levels were notably high, reflecting positively on the perceived efficacy of the product, which is crucial for ensuring adherence to treatment protocols.</p>
<p>Limitations of the study include the need for a longer duration of investigation to fully appreciate the long-term effects of any cosmetic product on skin health, particularly concerning wrinkles and under-eye bags. The brief study duration may have constrained the extent of observed results; however, the outcomes achieved during the study period were promising.</p>
<h2>Final Thoughts on the Efficacy of Nutrakos Eye Contour Gel</h2>
<p>Utilizing the <b>Nutrakos Eye Contour Gel (Professional Dietetics S.p.A., Milano, Italy) for a period of 28 days, applied twice a day, effectively improved the appearance and wellness of the periocular area. Participants reported excellent tolerability, and the product was ophthalmologically tested. This study represents a significant finding, being the first to document the efficacy of a cosmetic product in reducing under-eye bag volume and dark circle coloration while simultaneously enhancing signs of aging.