Hye Sung Han’s research while affiliated with Chung-Ang University Hospital and other places

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Publications (72)


Response rate (%) at frowning by the investigator’s live assessment.
Response rate (%) at rest by the investigator’s live assessment. * p-value of <0.05.
Response rate (%) at frowning by the patients’ improvement assessment. * p-value of <0.05.
Response rate (%) at rest by the patients’ improvement assessment.
Patients’ satisfaction rates. * p-value of <0.05.
Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19
  • Article
  • Full-text available

March 2025

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12 Reads

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1 Citation

Hye Sung Han

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Yangwon Lee

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Beom Joon Kim

MBA-P01 is a newly developed botulinum toxin A (BoNT-A) product designed to provide similar clinical effects as OnabotulinumtoxinA (ONA-BoNT-A), thereby providing an alternative treatment option for glabellar lines. It is another holotoxin preparation containing BoNT-A1. This randomized, double-blind, active-controlled, multi-center, Phase III clinical trial aimed to evaluate the efficacy and safety of MBA-P01 compared with OnabotulinumtoxinA (ONA-BoNT-A). In total, 318 participants were enrolled and received 20 units of MBA-P01 or ONA-BoNT-A on the forehead and glabella. At the 4-week assessment, the primary endpoint revealed no significant difference in the improvement rate of glabellar wrinkles between the two groups, confirming the non-inferiority of MBA-P01 to ONA-BoNT-A. Furthermore, some evaluation variables showed higher improvement rates for MBA-P01 than for ONA-BoNT-A. Adverse reactions and other safety analysis results were considered acceptable. Interestingly, a subgroup analysis of patients with the coronavirus disease (COVID-19) showed that the duration of BoNT-A treatment was shorter among those who contracted COVID-19 after BoNT-A treatment compared with those who have not. The limitations of this study include the predominance of female participants and the exclusive enrollment of Korean patients. MBA-P01 is expected to be clinically useful in terms of the efficient and safe reduction of glabellar wrinkles, which will provide patients with additional treatment options.

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(A) Eye wrinkle severity based on the Crow’s Feet Grading Scale (CFGS) during follow-up; (B) Eye wrinkle improvement based on CFGS scores; (C) Fine facial wrinkles based on the Cheek Line Grading Scale (CLGS) during follow-up; (D) Facial wrinkle improvement based on CLGS scores. Rt: right, Lt: left
Investigator and participant Global Aesthetic Improvement Scale (GAIS) scores (3: very much improved, 2: much improved, 1: improved, 0: no change, -1: worse).
A clinical photograph of a representative case face lift acquired using Mark-Vu. White arrows indicate sagging jowl improvement.
An Antera 3D representative case photograph of the eye and fine facial wrinkles during follow-up.
Roughness index based on Antera 3D. (A) Periorbital area. (B) Cheek area.
A multicenter pilot study of the effectiveness and safety of a monopolar radiofrequency device for improving periorbital and facial fine wrinkles

March 2025

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70 Reads

Purpose This study aimed to investigate the effectiveness and safety of a new monopolar radiofrequency device equipped with a 5 cm² tip, against fine wrinkles around the eyes and cheeks. Materials and methods This multicentered, prospective pilot study involved treating participants with mild-to-moderate wrinkles on both periorbital areas and cheeks using the monopolar radiofrequency device for one session. One and four months after treatment, wrinkle reduction, overall esthetic improvement, adverse events, and vital signs were evaluated. Results The study involved 13 participants (age: 35–62 years) and on a five-point scale, periorbital wrinkles showed a significant reduction at 4 weeks (0.96 ± 0.65) and 16 weeks (1.04 ± 0.59). On a five-point scale, cheek wrinkles also decreased at weeks 4 and 16 (1.00 ± 0.55 and 1.12 ± 0.64, respectively). On a five-point scale (range: −1–3), overall global esthetic improvement was rated by the participants at weeks 4 and 16 to be 2.23 ± 0.80 and 2.31 ± 0.61, respectively. Adverse events were not observed during the follow-up. Conclusion A single session using the new monopolar radiofrequency device equipped with a 5 cm² tip safely and effectively improves mild-to-moderate periorbital and facial wrinkles.


Fig. 1. Representative clinical images demonstrating the effects of photothermal therapy. Before treatment (A) and after photo-thermal therapy treatment (B). Improvement in the acne lesions. The figures are published under agreement of the patient.
Fig. 2. Representative clinical images demonstrating the effects of fractional cell regeneration. Before treatment (A) and after fractional cell regeneration treatment (B). Marked improvement in the keratosis pilaris lesions. The figures are published under agreement of the patient. P r o v i s i o n a l P r o v i s i o n a l
Energy-based devices for active acne
Energy-based devices for acne scars, PIH, and postinflammatory erythema
Emerging Innovations in Acne Management: A Focus on Non-Pharmacological Therapeutic Devices

Journal of Korean medical science

Acne is a chronic inflammatory condition affecting the sebaceous glands, with approximately 80% of individuals experiencing it at some point in their lives. Among adolescents, the incidence is reported to exceed 85%. The disease can significantly impact both physical and emotional aspects of a person's quality of life, leading to permanent scarring, poor self-image, depression, and anxiety. The standard first-line treatment for acne vulgaris includes conventional pharmacological approaches such as keratolytics, topical or oral antibiotics, retinoids, and hormonal agents. However, these treatments are not universally effective due to patient noncompliance, adverse drug effects, and the emergence of antibiotic resistance in Cutibacterium acnes, often resulting in high rates of recurrence. Consequently, non-pharmacological therapies have been developed as safe and effective alternatives or supplements to pharmacological treatment. These non-pharmacological approaches can serve as standalone treatment modalities, adjuncts to pharmacological therapy, or maintenance treatments. Current literature lacks comprehensive data on the classification of these non-pharmacological treatment options. This paper aims to provide a brief overview of recent research on the practical applications and potential mechanisms of non-pharmacological therapies for both acne and acne scars. Through elucidating the distinct mechanisms and therapeutic roles of these treatments, we aim to assist dermatologists and other healthcare providers in formulating more effective disease management strategies, thereby encouraging further research in this area.


Fig. 1. Classification of air pollutant. Created with BioRender.com. PM: particulate matter, PAH: polycyclic aromatic hydrocarbon. P r o v i s i o n a l P r o v i s i o n a l
Fig. 2. Air pollutant-induced oxidative stress and its effects on skin. Created with BioRender.com. PM: particulate matter, PAH: polycyclic aromatic hydrocarbon, VOC: volatile organic compound, ROS: reactive oxygen species.
Fig. 3. Roles of the aryl hydrocarbon receptor in response to air pollutants. Created with BioRender.com. PM: particulate matter, PAH: polycyclic aromatic hydrocarbon, VOC: volatile organic compound, TCCD: 2,3,7,8-tetrachlorodibenzodioxin, BaP: benzo[a]pyrene, AhR: aryl hydrocarbon receptor, ARNT: aryl hydrocarbon receptor nuclear translocator, COX-2: cyclooxygenase-2, TNF-α: tumor necrosis factor-α, IL: interleukin, PGE-2: prostaglandin E2, Th17: T helper 17, Treg: regulatory T cell.
Fig. 4. Impacts of air pollutants on skin barrier and immunity. Created with BioRender.com. PM: particulate matter, PAH: polycyclic aromatic hydrocarbon, VOC: volatile organic compound, TCCD: 2,3,7,8-tetrachlorodibenzodioxin, BaP: benzo[a]pyrene, AhR: aryl hydrocarbon receptor, IL: interleukin, ICAM: intercellular adhesion molecule, COX-2: cyclooxygenase-2, TNF-α: tumor necrosis factor-α, NLRP3: NLR family pyrin domain containing 3, MMP: matrix metalloproteinase, ECM: extracellular matrix.
Fig. 5. Effects of air pollutants on various skin disorders and their potential mechanisms. Created with BioRender.com. PM: particulate matter, PAH: polycyclic aromatic hydrocarbon, VOC: volatile organic compound, AhR: aryl hydrocarbon receptor, Th17: T helper 17, Treg: regulatory T cell, UVB: ultraviolet B.
Air Pollution and Skin Diseases

Annals of Dermatology

Air pollution is a widespread environmental issue, with substantial global implications for human health. Recent epidemiological studies have shown that exposure to air pollution exacerbates various inflammatory skin conditions, including atopic dermatitis, psoriasis, or acne. Furthermore, air pollutants are associated with accelerated skin aging, hair loss, and skin cancer. The aim of this review is to elucidate the current understanding of the impact of air pollution on skin health, emphasizing the underlying mechanisms involved and existing therapeutic and cosmetic interventions available to prevent or mitigate these effects. A pivotal factor in the harmful effects of air pollution is the formation of reactive oxygen species and the resulting oxidative stress. The aryl hydrocarbon receptor signaling pathway also substantially contributes to mediating the effects of air pollutants on various skin conditions. Moreover, air pollutants can disrupt the skin barrier function and trigger inflammation. Consequently, antioxidant and anti-inflammatory therapies, along with treatments designed to restore the skin barrier function, have the potential to mitigate the adverse effects of air pollutants on skin health.


Subcytotoxic transepidermal delivery using low intensity cold atmospheric plasma

January 2025

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33 Reads

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2 Citations

Cold atmospheric plasma (CAP) has been utilized in various medical devices using its oxidative nature. Recent studies have provided evidence that CAP can facilitate the delivery of large, hydrophilic molecules through the epidermis to the dermis. On the other hand, a new approach called low-intensity CAP (LICAP) has been developed, allowing the plasma level to be controlled within a subtoxic range, thereby demonstrating various biological benefits without tissue damage. However, the ability of LICAP to enhance transepidermal delivery in sub-cytotoxic conditions has not been fully investigated. This study aims to determine the sub-cytotoxic range of exposure time for LICAP and, within the range, to investigate the effects of LICAP treatment on transepidermal drug delivery (TED) and mechanisms using human keratinocytes and a mouse model. For the in vitro studies, LICAP treatment was evaluated in human keratinocyte (HaCaT) cells by assessing reactive species production, DNA damage, and cytotoxicity profiles. Within the determined safety range, mechanistic analyses were conducted to examine LICAP-enhanced delivery pathways. mRNA expression and protein levels of tight and adherens junction genes were quantified, and changes in ultramicroscopic morphology of HaCaT monolayers were investigated. Intracellular delivery of fluorescein isothiocyanate (FITC)-dextran was also assessed. For the in vivo studies, E-cadherin expression and the transepidermal delivery (TED) of human epidermal growth factor (hEGF) were analyzed in LICAP-treated mouse dorsal skin. The upper safety range of LICAP exposure time, reducing cell viability by 70% (IC70 or LD30), was estimated at 34.3 s. Within the safety range, LICAP treatment downregulated multiple tight and adherens junction genes in HaCaT cells. Consistent with the in vitro results, the epidermal E-cadherin expression was reduced, and human epidermal growth factor (hEGF) was infiltrated in the dermis of the LICAP-treated mouse skin. Intercellular clefts were detected in the HaCaT cell monolayer immediately following LICAP treatment and intracellular delivery of FITC-dextran was confirmed after LICAP exposure. This study demonstrated that LICAP treatment enhances transepidermal permeation of hEGF, apparently via both paracellular and transcellular routes. Under our study conditions, LICAP treatment seems to be a novel approach to facilitate TED with low safety concerns in vitro. Further translational studies are needed for clinical evaluation.


Change in the distribution of the radiation dermatitis score (a), and change in the average radiation dermatitis score (b) measured using the 5-point grading system suggested by the RTOG
Change in the melanin index (a), and change in the absolute difference in melanin index between the control and test sides (b)
Compositions of Easydew MD cream (control cream) and Easydew MD regen cream (test cream)
Efficacy and safety of topical cream containing aminoacryl tRNA synthetase complex interacting 1-derived peptide in mitigating radiation dermatitis after adjuvant radiotherapy for breast cancer

January 2025

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39 Reads

Supportive Care in Cancer

Purpose Acute radiation dermatitis (ARD) is a frequent side effect experienced by breast cancer patients undergoing radiotherapy. This study aimed to assess the efficacy and safety of a topical cream containing aminoacryl tRNA synthetase complex interacting 1 (AIMP1)-derived peptide (AdP) in mitigating radiation dermatitis (RD) in breast cancer patients undergoing radiotherapy. Methods An 8-week single-center, prospective pilot study was conducted to compare the clinical efficacy and safety of an AdP-containing cream with a control cream lacking AdP for the mitigation of RD. Fifteen patients undergoing radiotherapy applied the test cream to the right side and the control cream to the left side of the radiation exposure site, bisected by the nipple line. RD was evaluated at baseline and at weeks 2, 4, 6, and 8, employing the 5-point grading system advocated by the Radiation Oncology Group (RTOG). Results The average RTOG score was lower on the test side in comparison to the control side, and a less pronounced increase in melanin index was observed on the test side. However, these differences were not statistically significant. Both sides exhibited increased skin hydration and decreased transepidermal water loss. Analyzing the maximum RTOG scores throughout the study, RD of maximum grades 1 and 2 was noted in 54.5% and 45.5% of patients on the test side. On the control side, the maximum grades 1 and 2 were observed in 45.5% and 54.5% of patients respectively. Conclusion The AdP-containing cream did not prove to be more effective than the control cream without AdP in mitigating RD. However, the total incidence of RD in our study was notably lower than previously documented, illustrating the protective effects of both the test and control creams.


The images of hairs of representative participants (A,C,E: Treated of LB-P9 0-week; B,D,F: Treated of LB-P9 24-week).
Evaluation of hair health effectiveness after 24 weeks (A ~ C) and subgroup analysis (D ~ F). (A) Change from baseline in hair luster, (B) Change from baseline in hair elasticity, (C) Change from baseline in satisfaction score for hair health. (D) Female with long hair of change from baseline in hair luster (n = 29), (E) Female with short hair of change from baseline in hair luster (n = 30), (F) Male with long and short hair of change from baseline in hair luster (n = 14). The results are presented as means ± SD, *p < 0.05.
Clinical trial flowchart.
Efficacy and safety of Latilactobacillus curvatus LB-P9 on hair health: a randomized, double-blind, placebo-controlled clinical trial

November 2024

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74 Reads

Introduction Numerous factors influence hair health, including genetic predisposition, hormonal changes, stress, nutritional deficiencies, medical conditions, or medications. With the rising interest in maintaining hair health, alternative approaches such as functional cosmetics and food products are gaining attention. Probiotics, health-beneficial live microorganisms, are emerging as potential candidates for improving hair health. Therefore, this study aimed to evaluate the effects and safety of oral intake of Latilactobacillus curvatus LB-P9 on hair health. Methods The study was a randomized, double-blind, placebo-controlled clinical trial involving participants (aged 18–60 years old) with mild to moderate hair damage. Participants were randomly assigned to the test (receiving LB-P9 supplements) or control (receiving a placebo) groups, respectively. Efficacy was assessed using measures such as hair luster, elasticity, and participant satisfaction. Safety evaluations comprised physical examinations, vital sign measurements, laboratory tests, and observation of adverse reactions. Results Overall, 80 participants were enrolled in the trial. Significant improvements were observed in hair luster, elasticity, and participant satisfaction in the test group compared to the control group. In the test group, the hair luster parameter increased by 1.65 ± 2.30 (LBNT) at 24 weeks (p < 0.001), indicating a 19% improvement over the control group. Subgroup analysis revealed significant improvement in hair luster among females with short hair. Additionally, hair tensile strength, reflecting hair elasticity and participant satisfaction are increased by 10.27 ± 16.40 (gf/mm²) at 24 weeks (p = 0.001) in the test group. The subjective indicator of participant satisfaction, which improves as survey scores decrease, significantly decreased in the test group by −17.81 ± 14.35 points (p < 0.001) after 24 weeks of consuming the test food than before consuming it. No significant adverse reactions were reported, and safety evaluations indicated no adverse effects linked to LB-P9 consumption. Conclusion Probiotics, including LB-P9, may serve as an alternative in the management of hair health. The findings of this study support the possible benefits of LB-P9 supplementation in enhancing hair luster and elasticity.


Administration sites of the test product. (a) Middle of the corrugators supercilii muscles. (b) Medial corrugators supercilii muscle. (c) Procerus muscle.
Incidence of TEAEs per cycle.
Treatment duration (days) in each cycle.
Participants’ satisfaction rate at weeks 4, 8 and 12 in each cycle.
Scores ≥5 were considered ‘satisfied.’
Retreatment interval (days) in each cycle.
Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study

October 2024

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43 Reads

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1 Citation

Purpose Following the introduction of new type of botulinum toxin (MBA-P01), a recent phase 3 study demonstrated that MBA-P01 showed comparable efficacy and safety to onabotulinumtoxin A for reducing glabellar lines. The primary objective of this study was to evaluate the long-term safety of repeated MBA-P01 administration for the treatment of glabellar lines. Materials and methods This multicenter, single-group, repeated-dose, long-term open-label extension study evaluated repeated treatment with MBA-P01 (20 U, five treatments over 16 months), with posttreatment evaluation performed up to 52 weeks. Results Based on the safety assessment results, no specific irreversible adverse reactions were associated with the safety profile of MBA-P01. Repeated treatment with MBA-P01 was effective for a treatment duration of 3–5 months. Conclusion In conclusion, multiple cycles of treatment of glabellar lines with MBA-P01 at a dose of 20 U were well tolerated. Clinical trial registration information: This study is registered in ClincalTrials.gov (NCT05321979).


Effect of the cold plasma on psoriasis improvement in psoriasis cell lines from HaCaT cell. (A) Cold plasma device (RE:DERM PLASM, JNL, Korea). (B) HaCaT cell viability was measured after 0, 10, 20, 30, 60, 120, 180, and 240 s of cold plasma treatment and 24 h post‐treatment by using WST‐8 assay. (C) HaCaT cell viability was measured after 0, 10, 20, 30, 60, 120, 180, and 240 s of cold plasma treatment and 0, 4‐, 8‐, 12‐, and 24‐h post‐treatment by using WST‐8 assay. (D) The relative expression level of inflammatory cytokines related with psoriasis mRNA level after cytokine mixture treatment for 0, 0.5, 1, 2, 6, and 12 h. (E) The relative expression level of inflammatory cytokines related with psoriasis mRNA level after cytokine mixture treatment, cold plasma was applied for 0, 2, 4, 6, 8, and 10 min. (F–H) The expression level of MAPK pathway, cell cycle, psoriasis relative marker after cytokine mixture treatment for 0, 0.5, 1, 2, 6, and 12 h. The values represent the mean ± standard deviation. Significant values are indicated as *p < 0.05, **p < 0.01, ***p < 0.001, **** p < 0.0001 versus Normal.
Cold plasma improves the symptoms of psoriasis in a psoriasis mimic BALB/c mice model. (A) A timetable of experimental treatments and sample collection. (B) Mouse photography by DSLR and Folliscope on Day 9. (C) The values of skin thickness, erythema, scale, and PASI (severity of psoriasis). Represent the mean ± standard deviation. Significant values are indicated as *p < 0.05, **p < 0.01, ***p < 0.001, **** p < 0.0001 versus Normal.
Cold plasma decreased the cytokines and factors related with psoriasis in a psoriasis mimic BALB/c mice model. (A) Mouse photography by DSLR and Folliscope on Day 9. (B) The relative expression level of inflammatory cytokines related with psoriasis mRNA level on Day 9 mouse back skin. (C–E) The expression level of MAPK pathway, cell cycle, psoriasis relative markers on Day 9 mouse back skin. (F) Representative images of H&E and MT‐stained of each treated mouse's skin on day 9. (G) IHC staining of CD34, Loricrin, s100a7, and CD4. Represent the mean ± standard deviation. Scale bar = 100 µm. Significant values are indicated as *p < 0.05 versus IMQ only.
Cold plasma decreased the cytokines and factors related with psoriasis in a psoriasis mimic BALB/c mice model. (A) Mouse photography by DSLR and Folliscope on Day 9. (B) The relative expression level of inflammatory cytokines related with psoriasis mRNA level on Day 9 mouse back skin. (C–E) The expression level of MAPK pathway, cell cycle, psoriasis relative markers on Day 9 mouse back skin. (F) Representative images of H&E and MT‐stained of each treated mouse's skin on day 9. (G) IHC staining of CD34, Loricrin, s100a7, and CD4. Represent the mean ± standard deviation. Scale bar = 100 µm. Significant values are indicated as *p < 0.05 versus IMQ only.
Cold plasma decreased the cytokines and factors related with psoriasis in a psoriasis mimic BALB/c mice model. (A) Mouse photography by DSLR and Folliscope on Day 9. (B) The relative expression level of inflammatory cytokines related with psoriasis mRNA level on Day 9 mouse back skin. (C–E) The expression level of MAPK pathway, cell cycle, psoriasis relative markers on Day 9 mouse back skin. (F) Representative images of H&E and MT‐stained of each treated mouse's skin on day 9. (G) IHC staining of CD34, Loricrin, s100a7, and CD4. Represent the mean ± standard deviation. Scale bar = 100 µm. Significant values are indicated as *p < 0.05 versus IMQ only.
Cold Plasma Ameliorates Imiquimod‐Induced Psoriasis‐Like Skin Inflammation in Mice

September 2024

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48 Reads

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2 Citations

Objectives Cold plasma has shown efficacy in various dermatological applications by reduces inflammatory responses and modulating cytokine expression. Therefore, this study aimed to investigate the therapeutic effects of cold plasma on psoriasis. Methods In psoriasis HaCaT cells with cold plasma, we confirmed the expression of inflammatory cytokines involved in psoriasis formation and MAPK pathway, cell cycle, and apoptosis‐related factors. In psoriasis‐like BALB/c mice model, the effects of cold plasma treatment on skin were visually assessed. The expression of psoriasis‐related factors was confirmed through qPCR, Western blotting, and Immunohistochemistry. Results Cold plasma led to a reduction in inflammatory cytokines including IL‐17A, IL‐23A, IL‐24, IL‐1β, and TNF‐α in the psoriasis cell line. It also modulated factors involved in the MAPK pathway and the cell cycle. In the psoriasis‐like mice model, cold plasma resulted in improvements in skin thickness, erythema, scaling, and PASI. Additionally, decreases in inflammatory cytokines like INF‐γ, IL‐23, and S100a7 were observed, along with improvements in MAPK pathway activation, apoptosis, and other psoriasis‐related factors. Conclusion Through in vitro and in vivo studies, our research highlights the potential of cold plasma as a novel therapeutic approach for psoriasis. Furthermore, cold plasma could serve as an adjunctive treatment for skin immunological diseases.


The improvement rate of crow's feet grading scale (CFGS) at (A) rest and (B) expression assessed by blinded evaluating investigators (EIs). DLMR01, PCL‐based dermal filler; RJR, Purified PN filler (Rejuran). Significant values are indicated as *p < 0.05.
Global Aesthetic Improvement Scale (GAIS) assessed by (A) treating investigator (TI) and (B) blinded subjects DLMR01, PCL‐based dermal filler; RJR, Purified PN filler (Rejuran). Significant values are indicated as *p < 0.05; **p < 0.01; ***p < 0.001; ****p < 0.0001.
Clinical photographs of representative subjects showing improvements in crow's feet wrinkle at rest and expression after treatment. DLMR01, PCL‐based dermal filler; RJR, Purified PN filler (Rejuran). The crow's feet grading scale scores were as follows; RJR Static: 3 point (Baseline), 1 point (Week 2), 2 point (Week 4), and 2 point (Week 12). RJR Dynamic: 3 point (Baseline), 2 point (Week 2), 2 point (Week 4), and 2 point (Week 12). DLMR01 Static: 3 point (Baseline), 3 point (Week 2), 2 point (Week 4), and 2 point (Week 12). DLMR01 Dynamic: 4 point (Baseline), 3 point (Week 2), 2 point (Week 4), and 2 point (Week 12).
A Randomized, Participant‐ and Evaluator‐Blinded, Matched‐Pair, Prospective Study Comparing the Safety and Efficacy Between Polycaprolactone and Polynucleotide Fillers in the Correction of Crow's Feet

September 2024

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196 Reads

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1 Citation

Background Dermal fillers have gained widespread popularity for facial cosmetic enhancement and anti‐aging treatments. Recently, polycaprolactone (PCL) and polynucleotides (PN) fillers have emerged as promising options owing to their safety and long‐lasting effects. Objectives This study aimed to compare the efficacy and safety of a novel PCL‐based dermal filler (DLMR01) with purified PN filler (RJR: Rejuran) in correcting crow's feet wrinkles. Materials and Methods A randomized, evaluator‐blinded, prospective split‐face study was conducted with 218 healthy Asian participants. The primary outcome was in the improvement rate of the Crow's Feet Grading Scale (CFGS) at rest after 12 weeks. Secondary outcomes included the improvement rate of the CFGS at expression and rest at earlier time points, changes in CFGS, and the Global Aesthetic Improvement Scale (GAIS) assessment. Results The results showed that DLMR01 was not inferior to RJR in improving crow's feet wrinkles, with a significantly higher CGFS improvement rate at week 12. Both fillers demonstrated good safety profiles, with mild and tolerable adverse events. No serious adverse events were reported during the study period. Conclusion DLMR01, a PCL‐based dermal filler, showed effectiveness and safety in improving wrinkles described as crow's feet. The study suggests that DLMR01 could be a promising option for noninvasive anti‐aging treatments.


Citations (38)


... Decreases over time (18) . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. ...

Reference:

Efficacy of Botulinum Toxin Type A in Reducing Facial Wrinkles: A Comprehensive Review of Clinical Outcomes
Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19

... Ahn et al. [155] observed expression of E-cadherin, occludine and claudin and came to conclusion that mostly expression is return to original state with 24 h and maximum downregulation after 3 h after plasma treatment. ...

Subcytotoxic transepidermal delivery using low intensity cold atmospheric plasma

... The significance of developing new BoNT-A formulations lies not in creating entirely new molecular structures but in increasing accessibility, providing physicians and patients with alternative choices that maintain efficacy and safety. Previously published data provided a comparative overview of MBA-P01 and other commercially available BoNT-A formulations, highlighting their compositional similarities, which can be referenced in the long-term extension study [8,9]. ...

Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study

... HA-based skin boosters are well-recognized for their hydrating properties, while PDRN and exosomes contribute to long-term regenerative effects. [12][13][14][15][16][17] The observed improvements in lip texture, hydration, and color enhancement suggest that a multi-product approach may provide a more holistic and long-lasting outcome than monotherapy. However, additional studies with larger sample sizes and extended follow-up periods are necessary to validate these findings. ...

A Randomized, Participant‐ and Evaluator‐Blinded, Matched‐Pair, Prospective Study Comparing the Safety and Efficacy Between Polycaprolactone and Polynucleotide Fillers in the Correction of Crow's Feet

... Melanocytic activation involves increased melanocyte activity without a notable increase in cell numbers, whereas hyperplasia results in excessive pigment-producing cell growth in the nail matrix. [70,71] Picosecond lasers, known for their efficacy in pigment clearance with minimal thermal damage, have shown promise in treating various forms of melanonychia. Letrozole-induced benign melanonychia achieved complete resolution using a picosecond laser. ...

1,064-nm and 532-nm picosecond neodymium-doped:yttrium-aluminum-garnet laser treatment for longitudinal melanonychia: a case report
  • Citing Article
  • March 2024

Medical Lasers

... 3.9. In Situ Cellular Tyrosinase Activity Assay Using B16F10 Cells [67,68] B16F10 (3 × 10 3 cells/well) cells in a 24-well plate were incubated for 24 h in a 5% CO 2 incubator maintained at 37 • C. Each well was treated with a test sample (5, 2, and 1 µM for 5 and 9 and 5 µM for kojic acid [positive control]). Stimulators (α-MSH and IBMX; 1 µM and 200 µM, respectively) were exposed to cells 1 h after treatment with the test sample, and the cells were incubated for 72 h in a 5% CO 2 incubator. ...

Anti‐melanogenic effect of exosomes derived from human dermal fibroblasts (BJ‐5ta‐Ex) in C57BL/6 mice and B16F10 melanoma cells
  • Citing Article
  • September 2023

Pigment Cell & Melanoma Research

... However, the complex anatomy of the cheek region, including its layered structure of skin, fat compartments, muscles, and neurovascular elements, necessitates a thorough understanding of facial anatomy and precise injection techniques. The varied preferences for cheek aesthetics among different ethnic groups further complicate treatment approaches, requiring practitioners to tailor their techniques to achieve natural-looking results that align with patient's cultural ideals of beauty [1,2,[9][10][11][12]. ...

Needleless laser injector versus needle injection for skin enhancement and rejuvenation effect of dermal filler
  • Citing Article
  • August 2023

Lasers in Surgery and Medicine

... Therapeutic impact maintenance and limiting recurrence is critical for melasma treatment and traditional therapeutic methods do not address this issue effectively. However, new research findings indicate that dermal regeneration can be enhanced using targeted therapies, such as radiofrequency, pulsed dye lasers, and pulsed solid light, maintaining therapeutic impact for longer [26][27][28]. For example, Han et al. [29] treated 11 female patients with melasma for 2 months using a routine treatment that included oral tranexamic acid and a topical triple cream followed by microneedle radiofrequency for maintenance and found that even after conventional therapy discontinuation, the radiofrequency study arm remained better at 6 months, whereas in the untreated arm, 63.6% of the participants returned to baseline levels. ...

Full-thickness skin rejuvenation by a novel dual-length microneedle radiofrequency device: A proof-of-concept study using human skin
  • Citing Article
  • August 2023

Lasers in Surgery and Medicine

... According to the IHC assay, filaggrin protein expression was effectively restored by the application of PNs and PN+HA. Previous reports indicated that filaggrin expression, which has been reduced by various stimuli, increases with improvement of AD symptoms [43][44][45][46]. Hence, increased expression of filaggrin upon treatment with PNs and PN+HA provides valuable molecular evidence that these substances are candidates for topical AD treatments. ...

Adipose-derived stem cell exosomes for treatment of dupilumab-related facial redness in patients with atopic dermatitis

... Indeed, one of the main factors contributing to premature skin aging is photoaging caused by ultraviolet (UV) irradiation [6]. Deep wrinkles and texture changes are among the many alterations in the skin due to photoaging caused by increased MMP [7-9] and production of reactive oxygen species (ROS), which intensify oxidative stress [10]. This results in the overexpression of proinflammatory cytokines. ...

A Randomized, Prospective, Split-Face Pilot Study to Evaluate the Safety and Efficacy of 532-nm and 1,064-nm Picosecond-Domain Neodymium:Yttrium-Aluminum-Garnet Lasers Using a Diffractive Optical Element for Non-Ablative Skin Rejuvenation: Clinical and Histological Evaluation

Annals of Dermatology