Efficacy and safety of a panthenol‐enriched mask for individuals with distinct impaired skin barrier subtypes

The protection for different skin types with impaired skin barrier in the market is insufficient.


| INTRODUC TI ON
Impaired skin barrier is a prevalent and complex condition that affects a significant portion of the global population.It encompasses a variety of skin types, including dry sensitive, oily sensitive, and oily acne skin.These distinct skin types often present unique symptoms and responses to external stimuli, such as environmental factors, allergens, and irritants. 1The pathophysiology of impaired skin barrier involves a disruption in the skin's protective function, leading to increased transepidermal water loss (TEWL), altered lipid composition, and heightened susceptibility to inflammation and infection. 2dividuals with impaired skin barriers, particularly those with oily acne skin, may experience a range of negative impacts on their quality of life, including anxiety, depression, and social discomfort due to their skin condition. 3e panthenol-enriched mask contains several key ingredients with demonstrated potential to enhance skin barrier function, regulate sebum production, increase hydration levels, and reduce inflammation and post-inflammatory erythema (PIE) and postinflammatory hyperpigmentation (PIH).Panthenol is a well-known ingredient for its soothing, hydrating, and skin-barrier strengthening properties. 4,5Ceramides are essential for maintaining skin barrier integrity, and their topical application has been shown to improve skin barrier function and hydration. 6Additionally, bisabolol, a naturally occurring compound found in chamomile, possesses anti-inflammatory properties and has been reported to alleviate skin irritation. 7However, research investigating the efficacy of masks across these three skin barrier impairment subtypes is limited or nonexistent.
This multi-centered controlled study aimed to evaluate the efficacy and safety of a panthenol-enriched mask across three distinct skin barrier impairment subgroups-dry sensitive, oily sensitive, and oily acne skin.The study assessed the effects of key ingredients, such as bisabolol, ceramide, nutripeptide, panthenol, centellead, and hyaluronic acid, to target the specific concerns of each skin barrier impairment subgroup.Efficacy parameters included clinical assessment, instrumental assessment, self-assessment, tolerance assessment, and efficacy assessment.

| Intervention
Participants were instructed to apply the facial mask, which contains active ingredients such as Centella, Panthenol, Bisabolol, Nutripeptide, Ceramide, Hyaluronic Acid, and La Roche-Posay Thermal Spring Water, three times a week for a duration of 2 weeks.
This was done at night as part of their skincare routine, after gentle cleansing with the provided cleanser, replacing their regular mask product.

| Clinical assessment
All recruited subjects exhibited compromised skin barriers, characterized by either sensitive or acne-prone skin types.The determination of sensitive skin was achieved through a meticulously structured lactic acid tingling test, conducted 7 days prior to participant inclusion.This test involved preparing a 10% lactic acid solution using analytical balances, beakers, cylinders, and other precise instruments.The solution was then applied to cut pieces of nonwoven fabric measuring 0.5 by 1 cm.During the test, these fabric pieces, saturated with 0.01 mL of the lactic acid solution and saline for control, were randomly attached to both sides of the subjects' nasolabial folds.Sensory responses were systematically inquired about at specific intervals (0.5, 2.5, 5, and 8 min), and participants were scored based on the severity of their reactions (No impact: 0 points; Slight tingling, itching, redness: 1 point; Moderate but tolerable adverse reactions: 2 points; Severe, intolerable adverse reactions: 3 points).The final test result was the total score from the side with the lactic acid solution minus the total score from the side with saline.A result of 3 or more indicated sensitive skin.If a score of 3 was reached at any time during the test, the test was immediately terminated, the fabric was removed, and an alkaline solution or soap was applied to alleviate symptoms.Subjects were advised to report to the laboratory and seek treatment for adverse reactions persisting for over 24 h.For all subjects, a dermatological tolerance assessment was conducted by a board-certified dermatologist at multiple timepoints.
Objective irritation parameters (erythema, edema, dryness/scaling, and peeling) and subjective discomfort parameters (burning, stinging, itching, tightness, and tingling) were recorded.Signs present at baseline were documented but not considered as reactions.Clinical grading of efficacy parameters was performed using a modified Griffiths 10-point scale.
The panthenol-enriched mask's tolerance and efficacy were assessed using a comprehensive suite of dermatological tests, including objective irritation measures, subjective discomfort measures, and additional parameters such as skin texture, tone, and elasticity.
Objective parameters were scored on a scale of 0 (none) to 3 (severe), and subjective parameters were scored similarly.Statistical analysis was conducted to determine the significance of the results.

| VISIA-CR imaging procedure
This procedure was performed on all subgroups, capturing digital images of subjects' faces using the VISIA photo station (Canfield Imaging Systems, Fairfield, New Jersey) and a Canon Mark II digital SLR camera (Canon Incorporated, Tokyo, Japan) under normal, UV, and cross-polarized lighting.Porphyrin analysis was performed for oily sensitive and oily acne while skin redness (a* value) analysis was conducted for all subgroups using UV light source images.For the oily acne skin subgroup, PIH and PIE assessments were conducted.

| Sebumeter measurements
Sebumeter SM 815 (Courage + Khazaka electronic GmbH, Köln, Germany) was utilized to measure sebum quantity on the skin for all subgroups.Measurements were taken before washing the face to ensure accurate sebum quantification.Three measurements were taken on adjacent, nonoverlapping sites on the center of each subject's forehead.

| Tewameter measurements
Tewameter Hex (Courage + Khazaka electronic GmbH, Köln, Germany) was used to measure TEWL for all subgroups.One measurement was taken on the center of each subject's right or left cheek.
Three measurements were taken on the center of each subject's right or left cheek, on the opposite side of the face from Tewameter measurements.
Prior to measurements, subjects underwent a 30-min acclimation period in the test environment.The D0 measurement was established as the baseline before any product application.Subsequent measurements were then performed at D1 (15 min post-application), D7, and D14 to evaluate the changes over time.The measurements were carried out in a room where the temperature was consistently maintained at 22°C (±1°C), with a relative humidity of 45% (±5%).

| Statistical analysis
Statistical analyses were rigorously performed using SPSS software, version 28.0.All statistical tests were two-sided, with a significance level set at α = 0.05, unless otherwise specified.pvalues were reported to three decimal places (0.000), providing precision in our results' presentation.It should be noted that no adjustments for multiple testing were made in this study.Results from the instrumental assessments were analyzed using appropriate statistical methods, which included t-tests and ANOVA, to determine the significance of the findings.slightly increased to 158.51 ± 52.47 after 7 days (a 15.87% reduction from baseline), and decreased further to 149.79 ± 49.19 after 14 days (a 20.50% reduction from baseline) (Figure 1).TEWL, measured by Tewameter, decreased from a baseline mean of 17.03 ± 1.73 to 15.22 ± 1.83 after 1 day (a 10.62% reduction), and showed a consistent decrease to 15.67 ± 2.01 after 7 days (a 7.98% reduction from baseline), and to 15.54 ± 2.14 after 14 days (an 8.78% reduction from baseline) (Figure 2).Stratum corneum hydration, determined by Corneometer, increased from a baseline mean of 29.84 ± 6.72 to 37.92 ± 7.91 after 1 day (a 27.09% increase), remained stable at 37.67 ± 7.63 after 7 days (a 26.26% increase from baseline), and further increased to 39.93 ± 8.37 after 14 days (a 33.85% increase from baseline) (Figure 3).Skin redness, captured by VISIA analysis, decreased from a baseline mean of 25.32 ± 6.28 to 23.75 ± 5.85 after 1 day (a 6.20% reduction), to 24.89 ± 6.03 after 7 days, and to 24.65 ± 5.59 after 14 days (a 2.66% reduction from baseline) (Figure 4).Porphyrin feature count decreased from a baseline mean of 974.13 ± 677.08 to 907.33 ± 647.14 after 1 day (a 6.86% reduction), to 902.57± 621.01 after 7 days (a 7.35% reduction from baseline), and to 924.72 ± 670.73 after 14 days (a 5.07% reduction from baseline).Skin porphyrin score, also measured by VISIA, decreased from a baseline mean of 11.68 ± 7.92 to 10.96 ± 7.37 after 1 day (a 6.14% reduction), and remained stable at 10.91 ± 7.47 after 7 days and 11.13 ± 7.78 after 14 days (a 4.71% reduction from baseline).

| Tolerance and efficacy assessment
Tolerance assessment results indicated that the treatment was well-tolerated across all three skin types (dry sensitive, oily sensitive, and oily acne).No adverse reactions were observed, and the treatment was suitable for sensitive and oily acne skin.Reductions in erythema, dryness, scaling, and tightness were noted, with no significant changes in other irritation parameters.

| Self-assessment
Self-assessment results across the three skin types revealed positive experiences and significant improvements in skin sensations and appearance after product use at all measurement points (D0, D1/ T15min, D7, and D14).
For the three types of skin with impaired skin barrier, over 90% of participants reported an overall improvement in skin comfort, hydration, and texture, skin sensations and appearance.The product was considered lightweight, nongreasy, and nonsticky, with a pleasant scent, and provided a comfortable and soft experience, allowing free movement during use.

| DISCUSS ION
This multi-centered study assessed the efficacy and tolerance of a facial mask in repairing, hydrating, sebum regulation, and providing anti-inflammatory effects on various impaired skin barrier conditions.The performance of the mask on dry sensitive, oily sensitive, and oily acne skin types was evaluated through clinical assessment, objective instrumental measurements, and subjective self-assessments.A combination of clinical assessment, objective instrumental measurements and subjective self-assessments were used to evaluate the mask's performance on different skin types: dry sensitive, oily sensitive, and oily acne skin.
Upon evaluation of the results, the mask demonstrated strong hydrating and moisturizing properties across all three skin subgroups, with notable increases in hydration and decreases in TEWL in all skin types.These effects which could be attributed to the presence of panthenol, hyaluronic acid, ceramide, and thermal water in the formulation.Previous study by Wolfgang and Max 4 showed the repairing effects for skin barrier function and stratum corneum hydration, ceramides contribute to the reinforcement of the skin barrier function, 6 hyaluronic acid is known for its ability to retain water and provide hydration 9 while the La Roche-Posay thermal spring water has a great effect of reducing dryness. 10Notably, the dry sensitive subgroup exhibited a greater increase in hydration and a greatest decrease in TEWL, possibly because this skin type has a more compromised barrier function and a lower starting hydration level, making the relative change more pronounced.
The sebum regulation effects of the studied mask could be observed in the results across all three skin subgroups, demonstrating the mask's ability to balance sebum production depending on the skin type.For the dry sensitive skin subgroup, the mask notably increased sebum levels, suggesting an enhancement of the skin barrier-vital for sebum-deficient conditions.Conversely, it reduced sebum in oily skin types, aligning with the ideal sebum range and indicating the mask's role in lipid matrix homeostasis.The skin sebum levels tended to approach a normal range after using the mask, from 100 to 150 μg/cm, 2 which fit the average amount of sebum level (around 145 μg/cm 2 ). 11This regulation points to the mask's role in stabilizing the skin's lipid matrix.The harmonization of sebum levels is likely attributable to the combined action of panthenol and ceramides in the mask, known for their efficacy in repairing and maintaining the lipid balance within the stratum corneum. 5,6The balanced amount of sebum secretion is a key index of a healthy skin barrier. 12e mask's anti-inflammatory effects were also observed in all three subgroups: in the reduction of skin redness in the dry sensitive skin subgroup, decreased porphyrin scores 13 in the oily sensitive skin subgroup, and the decreased PIH/PIE and skin redness in the oily acne subgroup.The skin redness reduction was most significant in the oily acne skin subgroup, followed by the oily sensitive and dry sensitive subgroups.While the dry sensitive skin subgroup showed the least reduction in redness, the improvement is nonetheless noteworthy, given the lower baseline inflammation in this group.
These effects are likely owing to the presence of panthenol, Centella Asiatica, bisabolol, and thermal water, which have anti-inflammatory properties that help calm the skin.Centellead (Centella Asiatica), Panthenol, and Bisabolol are known for their soothing and antiinflammatory properties. 7,14,15Collectively, these results suggest that the mask's formulation not only addresses hydration and sebum regulation but also plays a significant role in mitigating inflammatory symptoms across various skin types, reinforcing the integrity of the physical barrier, supporting the balance of the chemical barrier, and enhancing the skin's immunological barrier function. 16th the difference of efficacy significantly different between dry skin and oily skin addressed before, the significance of evaluating the mask's efficacy between oily sensitive skin and oily acne skin could not be overstated.Data indicate that the mask's efficacy in regulating sebum, enhancing hydration, and reducing TEWL is indeed more pronounced in the oily acne subgroup.This suggests a heightened responsiveness in individuals with acne skin, who typically exhibit a compromised skin barrier and increased inflammatory activity. 17Notably, the oily acne subgroup showed a greater reduction in sebum content and improvements in hydration, accompanied by a more substantial decrease in TEWL, compared to the oily sensitive subgroup.Such findings imply a superior efficacy of the mask in restoring skin barrier function and mitigating inflammation in more severely affected skin conditions.
It is important to recognize that the sample sizes for each subgroup were not perfectly balanced, with 64 participants having dry sensitive skin, 61 participants having oily sensitive skin, and 52 participants having oily acne skin.This discrepancy in sample sizes could potentially introduce bias into the study.However, given that each subgroup was analyzed independently, the impact on the overall findings is likely minimal.Nevertheless, future research with more balanced sample sizes would be beneficial to further validate the findings of this study.
In conclusion, this study demonstrates that the studied mask is an effective and well-tolerated treatment for various skin types, including dry sensitive, oily sensitive, and oily acne skin, all of which represent different subgroups of impaired skin barrier.The mask effectively regulated sebum production, improved hydration levels, reduced TEWL, and diminished skin redness across the three This comprehensive, multi-centered controlled study enrolled 177 adult participants aged 18-45 years.Participants were categorized into three subgroups based on clinical assessments: 64 with dry sensitive skin, as determined by physician judgment after subject declaration; 61 with oily sensitive skin, confirmed through a structured lactic acid tingling test indicating a heightened skin response; and 52 with oily skin presenting mild to moderate acne, characterized by non-inflammatory and inflammatory lesions without receiving standard acne treatment.Inclusion criteria were the following: (1) 18 years of age or older at the time of enrollment; (2) a confirmed diagnosis of dry sensitive, oily sensitive, determined through a lactic acid stimulation test indicating a heightened skin response, or oily skin with mild to moderate acne, characterized by non-inflammatory and inflammatory lesions as well as PIE and PIH; (3) ability to provide informed consent and willingness to participate in the study; (4) ability to comply with the study protocol, including attending scheduled visits, undergoing necessary assessments, and adhering to treatment regimens; and (5) no participation in another interventional study within 30 days prior to enrollment.Key exclusion criteria were the following: (1) presence of any other significant medical condition that, in the investigator's opinion, could interfere with the participant's ability to comply with the study protocol or affect the safety of the participant; (2) pregnant or breastfeeding women, or women of childbearing potential who are not using adequate contraception; (3) known hypersensitivity or allergy to any of the study medications; (4) a history of substance abuse or dependence within the past 6 months that could affect the participant's ability to adhere to the study protocol; (5) any contraindication to the study medications as detailed in the prescribing information; and (6) (for the oily acne subgroup) receiving standard treatment for acne.

3 | RE SULTS 3 . 1 |
Baseline patient characteristicsA total of 201 subjects were screened for inclusion in the study, with 177 subjects ultimately meeting the criteria and being included in the analysis.This sample size was determined based on empirical evidence and previous research to ensure sufficient statistical power.The study population encompassed three subgroups: dry sensitive skin, oily sensitive skin, and oily acne skin.For the dry sensitive skin subgroup, 64 subjects were analyzed, with an average age of 37.59 ± 5.96 years, ranging from 23 to 45 years old.In the oily sensitive skin subgroup, 61 subjects were included in the analysis, with an average age of 32.95 ± 6.89 years, ranging from 19 to 45 years old.The oily acne skin subgroup comprised 52 subjects, with an average age of 31.46 ± 6.52 years, ranging from 19 to 44 years old.The average age for the entire cohort was 34.00 ± 7.13 years, demonstrating the representation of different age groups in the study population.