Volume 24, Issue 4 e70171
LETTER
Open Access

Prospective Efficacy of Cutotype-Specific Personalized Topical Postbiotic Emollients in Females: A Single-Center, Cluster-Based, Pre-Post, Nonrandomized Controlled Trial in South Korea

Jiyeon Oh

Jiyeon Oh

Department of Medicine, Kyung Hee University College of Medicine, Seoul, South Korea

Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea

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Hyeon Jin Kim

Hyeon Jin Kim

Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea

Department of Regulatory Science, Kyung Hee University, Seoul, South Korea

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Seoyeon Kyung

Seoyeon Kyung

Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea

Department of Regulatory Science, Kyung Hee University, Seoul, South Korea

Research and Innovation Center, Cosmax BTI, Seongnam, South Korea

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Jiseung Kang

Jiseung Kang

Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA

Division of Sleep Medicine, Harvard Medical School, Boston, Massachusetts, USA

School of Health and Environmental Science, Korea University College of Health Science, Seoul, South Korea

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So Min Kang

So Min Kang

Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea

Korea Biomedical Research Institute, Seongnam, South Korea

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Dasom Jeon

Dasom Jeon

Korea Biomedical Research Institute, Seongnam, South Korea

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Hye-Been Kim

Hye-Been Kim

Research and Innovation Center, Cosmax BTI, Seongnam, South Korea

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HyungWoo Jo

HyungWoo Jo

Research and Innovation Center, Cosmax BTI, Seongnam, South Korea

Department of Microbiology, Dankook University, Cheonan, South Korea

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Dong-Geol Lee

Dong-Geol Lee

Research and Innovation Center, Cosmax BTI, Seongnam, South Korea

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Dong Keon Yon

Corresponding Author

Dong Keon Yon

Department of Medicine, Kyung Hee University College of Medicine, Seoul, South Korea

Center for Digital Health, Medical Science Research Institute, Kyung Hee University College of Medicine, Seoul, South Korea

Department of Regulatory Science, Kyung Hee University, Seoul, South Korea

Department of Pediatrics, Kyung Hee University College of Medicine, Seoul, South Korea

Correspondence:

Dong Keon Yon ([email protected])

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First published: 07 April 2025

Funding: This work was supported by the National Research Foundation of Korea (RS-2023-00248157) and Cosmax BTI. The study steering committee led the trial design, with support from the sponsor (Cosmax BTI). The sponsor was responsible for preparing the trial protocol, the statistical analysis plan, and the collection and analysis of data. The sponsor assisted the authors in data interpretation, writing the report, reviewing the manuscript, and in the decision to submit for publication.

Jiyeon Oh, Hyeon Jin Kim and So Min Kang are contributed equally. HyungWoo Jo, Dong-Geol Lee and Dong Keon Yon are jointly supervised the work.

To the Editor,

1 Introduction

Skin, the human body's largest organ, hosts diverse microbiomes that regulate host immunity and maintain skin physiology [1]. With advancements in metagenomics sequencing [2], our understanding of microbial diversity and composition has significantly expanded. Its composition substantially varies between individuals; therefore, several studies have identified distinct cutotypes, or microbial sub-community clusters, in various ethnic populations [3]. Our previous study established a comprehensive set of criteria to classify South Koreans' cutotype into 12 groups, considering both biophysical characteristics and microbiome composition [4]. Each of the four skin groups—HL (high in tone/elasticity but low in oil/water), LH (low in tone/elasticity but high in oil/water), LL (low in both), HH (high in both)—is further stratified by age groups (young, 10–34 years; aging, 35–50 years; old, ≥ 51 years) [4].

Given the complex interplay between the application of skincare products and the skin microbiome, it has been a novel objective for skincare products to maintain the skin microbiome. A previous study underscored the positive role of Staphylococcus in increasing skin moisture, Rothia in mitigating inflammation, Cutibacterium in boosting nutrition, and Streptococcus in improving elasticity [5]. Skincare products tailored to an individual's cutotype may help address specific skin concerns more effectively by balancing the unique microbial system on the skin. Moreover, supporting the natural balance of the skin microbiome may further contribute to long-term skin health, maintaining the skin's protective barrier. Thus, we aimed to develop a microbiome postbiotic emollient, with different microbiome compositions for each cutotype, for Korean females with low tone/elasticity (i.e., LL and LH) and evaluate the effects of these products on skin hydration, elasticity, and tightness.

2 Methods

2.1 Study Setting and Design

This is a prospective, single-center, and pre-post cluster nonrandomized controlled trial conducted in South Korea between Jun 2023 and October 2023, following the principles of the Declaration of Helsinki. Written informed consent was collected from all participants before enrollment, and this study was approved by the Ethics Committee of Korea Biomedical Research Institute Institutional Review Board (E-2023-010-01). Participants were enrolled by the Korea Biomedical Research Institute (single center). The study was registered with the Clinical Research Information Service of South Korea (KCT0009958).

A total of 126 healthy females aged 10 years or older were recruited. Inclusion criteria included low skin tone or elasticity (LL and LH cutotypes) without any chronic skin conditions, such as atopic dermatitis or psoriasis. Participants were stratified by cutotype and age group (young, 10–34 years; aging, 35–50 years; old, ≥ 51 years): 22 young LH, 21 aging LH, 21 old LH, 20 young LL, 21 aging LL, and 21 old LL.

2.2 Outcomes

We used a questionnaire about skin-related symptoms to describe the baseline characteristics of participants. We applied the microbiome-based fermented emollient to all participants but with different compositions based on cutotypes. The microbiome composition was determined to fill the skin elasticity and moisture for each cutotype as follows: Staphylococcus (15%) and Rothia (15%) for LH and Cutibacterium (11%), Staphylococcus (6%), and Streptococcus (13%) for LL. There was no difference in microbiome composition across age groups within the same type. All microbiomes were sourced from the COSMAX Microbiome Bank (CMB; COSMAX BTI Inc., Seongnam, South Korea) [6]. Participants applied daily cutotype-specific, topical postbiotic emollients for 2 weeks.

Before and after application of the emollient, we assessed skin hydration (range, 0–120 A.U.; Corneometer CM 825 [Germany]), skin elasticity (range, 0%–100%; Cutometer MPA580 [Germany]), and skin tightness (range, 0°–90°; F-RAY [South Korea]) for all individuals. We used Image-Pro 10 (USA) to assess the skin tightness parameter. Higher values indicated improved skin hydration and elasticity, while lower values indicated improved skin tightness.

2.3 Sample Size Calculation

Based on our previous large-scale randomized controlled trial [6], the study originally estimated that the pre-post group would have 70% power to demonstrate an improvement in skin hydration among participants (4.56 in the placebo group versus 9.37 in the intervention group) at a 5% significance level with a 1:1 ratio. Initially, 19 participants were enrolled in each group. Taking into account a 10% dropout rate, the final sample consisted of 21 participants, considering the nature of the pre-post setting. Although there were no previous studies on skin tightness and elasticity, based on the expected sample size for skin hydration, it was assumed that the same mechanism would apply, and therefore, the same sample size was designated.

2.4 Statistical Analysis

A paired t-test was performed to assess the effectiveness of microbiome-based skincare products for each cutotype group, with estimates of mean difference and 95% confidence intervals (95% CIs). We used R statistical software, version 4.4.0 (R Foundation for Statistical Computing), to perform all statistical analyses. A two-sided p-value < 0.05 was considered statistically significant.

3 Results

The mean age of the 126 participants was 45.06 (standardized deviation, 15.19) years, with ages ranging from 20 to 67 years. Baseline characteristics, such as sleep time, sunlight exposure, smoking, and phase of menstrual cycle, are detailed in Table 1. Improvements in skin hydration, elasticity, and tightness were observed across all age groups for both cutotypes (Table 2). The most significant increase in skin hydration was observed in aging LH, with a mean difference of 1.76 (95% CI, 1.25–2.28), whereas the greatest enhancements in elasticity and tightness were found in young LH (elasticity, 0.60 [95% CI, 0.33–0.87]; tightness, −1.03 [95% CI, −1.36 to −0.70]). Similarly, for LL, three age groups showed enhanced skin hydration, elasticity, and tightness. The most considerable increase in skin hydration was found in young LL (4.39 [95% CI, 2.52–6.26]), while aging LL exhibited the most significant enhancements in elasticity and tightness (elasticity, 0.72 [95% CI, 0.22–1.22]; tightness, −0.76 [95% CI, −1.25 to −0.27]). No significant safety problems were reported during the study, although 3.17% (4/126) of participants reported itchy skin after the microbiome emollient.

TABLE 1. Baseline characteristics of 126 females.
Continuous variable, mean (SD)
Age, years 45.06 (15.19)
Continuous variables, n (%)
Cutotype
Young LH 22 (17.46)
Aging LH 21 (16.67)
Old LH 21 (16.67)
Young LL 20 (15.87)
Aging LL 21 (16.67)
Old LL 21 (16.67)
Sleep time (per day)
< 4 h 1 (0.79)
4–8 h 111 (88.10)
≥ 8 h 14 (11.11)
Sunlight exposure (per day)
< 1 h 46 (36.51)
1–4 h 78 (61.90)
≥ 4 h 2 (1.59)
Smoking (pack of cigarettes per day)
None 121 (96.03)
Half 4 (3.17)
Half to one 1 (0.79)
Itchy skin after the application of the microbiome regimen
Yes 4 (3.17)
No 122 (96.83)
Skin changes during menstruation
Yes 27 (21.43)
No 44 (34.92)
Menopause 55 (43.65)
Phase of the menstrual cycle
Within a week before menstruation 18 (14.29)
During menstruation 8 (6.35)
After a week of menstruation 19 (15.08)
Menopause 56 (44.44)
Unknown 25 (19.84)
  • Abbreviations: LH, low in tone/elasticity and high in oil/water; LL, low in tone/elasticity and oil/water; SD, standard deviation.
TABLE 2. Mean difference of skin hydration, elasticity, and tightness between before- and after-test.
Variables Pre-test, mean (95% CI) Post-test, mean (95% CI) Difference between pre-test and post-test
Mean difference (95% CI) p
Young LH (n = 22)
Skin hydration 58.20 (52.62 to 63.78) 59.13 (53.55 to 64.71) 0.93 (0.51 to 1.36) < 0.001
Skin elasticity 75.10 (73.20 to 77.01) 75.70 (73.80 to 77.60) 0.60 (0.33 to 0.87) < 0.001
Skin tightness 40.59 (38.49 to 42.68) 39.56 (37.57 to 41.54) −1.03 (−1.36 to − 0.70) < 0.001
Aging LH (n = 21)
Skin hydration 60.97 (56.76 to 65.19) 62.74 (58.38 to 67.10) 1.76 (1.25 to 2.28) < 0.001
Skin elasticity 73.71 (71.79 to 75.64) 74.07 (72.13 to 76.00) 0.35 (0.25 to 0.46) < 0.001
Skin tightness 37.42 (34.95 to 39.90) 36.63 (34.07 to 39.18) −0.80 (−1.25 to − 0.35) 0.002
Old LH (n = 21)
Skin hydration 54.29 (51.82 to 56.76) 55.12 (52.71 to 57.53) 0.83 (0.57 to 1.08) < 0.001
Skin elasticity 71.53 (69.71 to 73.34) 71.75 (69.90 to 73.60) 0.22 (0.14 to 0.31) < 0.001
Skin tightness 33.29 (31.26 to 35.32) 32.90 (30.88 to 34.91) −0.40 (−0.46 to − 0.33) < 0.001
Young LL (n = 20)
Skin hydration 55.12 (52.07 to 58.16) 59.51 (55.92 to 63.10) 4.39 (2.52 to 6.26) < 0.001
Skin elasticity 75.83 (74.10 to 77.56) 76.38 (74.62 to 78.13) 0.54 (0.26 to 0.83) < 0.001
Skin tightness 38.43 (36.80 to 40.06) 37.80 (36.13 to 39.47) −0.63 (−1.10 to − 0.17) 0.011
Aging LL (n = 21)
Skin hydration 49.79 (47.29 to 52.29) 50.71 (48.30 to 53.12) 0.92 (0.50 to 1.35) < 0.001
Skin elasticity 69.50 (67.30 to 71.71) 70.23 (68.16 to 72.30) 0.72 (0.22 to 1.22) 0.007
Skin tightness 34.25 (31.65 to 36.85) 33.49 (30.85 to 36.13) −0.76 (−1.25 to − 0.27) 0.004
Old LL (n = 21)
Skin hydration 47.76 (45.39 to 50.14) 48.48 (45.97 to 50.99) 0.71 (0.36 to 1.07) < 0.001
Skin elasticity 70.12 (68.35 to 71.89) 70.45 (68.70 to 72.20) 0.33 (0.17 to 0.49) < 0.001
Skin tightness 39.40 (36.10 to 42.70) 39.14 (35.84 to 42.43) −0.26 (−0.33 to − 0.19) < 0.001
  • Note: Number in bold indicates a significant difference (p < 0.05).
  • Abbreviations: CI, confidence interval; LH, low in tone/elasticity and high in oil/water; LL, low in tone/elasticity and oil/water.

4 Discussion

This study showed the efficacy of microbiome-based emollients tailored to specific cutotypes in improving skin hydration, elasticity, and tightness. The results underscore the potential therapeutic applications of such products in personalized skincare. However, these findings should be interpreted with caution due to several limitations. The lack of investigation into changes in the microbiome composition hinders the direct assessment of this emollient's impact on the skin microbiome. In addition, we only recruited females, limiting our ability to generalize the findings to broader applications. Moreover, due to the nature of the pre–post-test study design, selection bias, and time-related bias may influence the changes observed between pre- and post-tests. Last, although the short duration of the intervention (2 weeks) was chosen to observe initial short-term effects, longer-term studies are needed to assess sustained outcomes.

5 Conclusion

Based on our novel classification of skin types, we developed skin care products for each cutotype. The microbiome skin care products customized for LL and LH cutotypes appear safe and effective, with significant improvements in skin hydration, elasticity, and tightness across all cutotype groups; however, the short intervention period and small sample size limit conclusions on long-term effects, warranting further research. This study may serve as a milestone for future studies investigating the association between cutotype and skin health.

Author Contributions

D.K.Y. had full access to all of the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis. All authors approved the final version of the manuscript before submission. Study concept and design: J.O., H.J.K., D-.G.L., and D.K.Y.; acquisition, analysis, or interpretation of data: J.O., H.J.K., D-.G.L., and D.K.Y.; drafting of the manuscript: J.O., H.J.K., D-.G.L., and D.K.Y.; critical revision of the manuscript for important intellectual content: all authors; statistical analysis: J.O., H.J.K., D-.G.L., and D.K.Y.; study supervision: D.K.Y. D.K.Y. supervised the study and served as a guarantor. J.O. and H.J.K. contributed equally. H.J., D-.G.L., and D.K.Y. contributed equally as corresponding authors. The corresponding author attests that all listed authors meet the authorship criteria and that no one meeting the criteria has been omitted.

Acknowledgments

The authors have nothing to report.

    Conflicts of Interest

    The authors declare no conflicts of interest.

    Data Availability Statement

    The data supporting this study's findings are available from the corresponding author upon reasonable request.

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