1.Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study
Hyung Seok SON ; Min Kyung SHIN ; Jong Hun LEE ; Moon Bum KIM ; Kwang Ho YOO ; Sun Young CHOI ; Hye Sung HAN ; Joon SEOK ; Beom Joon KIM ; Yang Won LEE
Annals of Dermatology 2026;38(1):33-41
Background:
A novel botulinum toxin type A (Protoxin; Protox Inc.) has been developed.
Objective:
To evaluate the efficacy and safety of the newly developed Protoxin compared to the approved drug onabotulinumtoxinA (OBoNT) in moderate to severe glabellar lines.
Methods:
Adults with a glabellar line Facial Wrinkle Scale (FWS) score of 2 (moderate) or 3 (severe) were enrolled in the study. Subjects were randomized in a 1:1 ratio to receive either Protoxin or OBoNT. A total of 20 units of botulinum toxin was injected at five sites in the glabellar region (4 units at each site). FWS scores were assessed at baseline and at weeks 4, 8, 12, and 16 post-injection. The primary endpoint was the proportion of subjects at week 4 who had a reduction of 2 or more points in FWS and a final score of 0 (none) or 1 (mild).
Results:
A total of 274 subjects were randomized, of whom 78.1% were female. At week 4 post-treatment, the improvement rate of glabellar lines was 62.22% in the Protoxin group and 62.96% in the OBoNT group. The lower limit of the two-sided 95% confidence interval (−12.24%) exceeded the −15% margin, confirming the non-inferiority of the new drug. Safety profiles were comparable between the two groups.
Conclusion
Protoxin demonstrated efficacy and safety profiles comparable to those of OBoNT in the treatment of moderate to severe glabellar lines.
2.Virtual Reality-Based Cognitive Behavior Therapy for Major Depressive Disorder: An Alternative to Pharmacotherapy for Reducing Suicidality
Miwoo LEE ; Sooah JANG ; Hyun Kyung SHIN ; Sun-Woo CHOI ; Hyung Taek KIM ; Jihee OH ; Ji Hye KWON ; Youngjun CHOI ; Suzi KANG ; In-Seong BACK ; Jae-Ki KIM ; San LEE ; Jeong-Ho SEOK
Yonsei Medical Journal 2025;66(1):25-36
Purpose:
Cognitive behavioral therapy (CBT) has long been recognized as an effective treatment for depression and suicidality.Virtual reality (VR) technology is widely used for cognitive training for conditions such as anxiety disorder and post-traumatic stress disorder, but little research has considered VR-based CBT for depressive symptoms and suicidality. We tested the effectiveness and safety of a VR-based CBT program for depressive disorders.
Materials and Methods:
We recruited 57 participants from May 2022 through February 2023 using online advertisements. This multi-center, assessor-blinded, randomized, controlled exploratory trial used two groups: VR treatment group and treat as usual (TAU) group. VR treatment group received a VR mental health training/education program. TAU group received standard pharmacotherapy. Assessments were conducted at baseline, immediately after the 6-week treatment period, and 4 weeks after the end of the treatment period in each group.
Results:
Depression scores decreased significantly over time in both VR treatment and TAU groups, with no differences between the two groups. The suicidality score decreased significantly only in VR group. No group differences were found in the remission or response rate for depression, perceived stress, or clinical severity. No adverse events or motion sickness occurred during the VR treatment program.
Conclusion
VR CBT treatment for major depressive disorder has the potential to be equivalent to the gold-standard pharmacotherapy in reducing depressive symptoms, suicidality, and related clinical symptoms, with no difference in improvement found in this study. Thus, VR-based CBT might be an effective alternative to pharmacotherapy for depressive disorders.
3.Virtual Reality-Based Cognitive Behavior Therapy for Major Depressive Disorder: An Alternative to Pharmacotherapy for Reducing Suicidality
Miwoo LEE ; Sooah JANG ; Hyun Kyung SHIN ; Sun-Woo CHOI ; Hyung Taek KIM ; Jihee OH ; Ji Hye KWON ; Youngjun CHOI ; Suzi KANG ; In-Seong BACK ; Jae-Ki KIM ; San LEE ; Jeong-Ho SEOK
Yonsei Medical Journal 2025;66(1):25-36
Purpose:
Cognitive behavioral therapy (CBT) has long been recognized as an effective treatment for depression and suicidality.Virtual reality (VR) technology is widely used for cognitive training for conditions such as anxiety disorder and post-traumatic stress disorder, but little research has considered VR-based CBT for depressive symptoms and suicidality. We tested the effectiveness and safety of a VR-based CBT program for depressive disorders.
Materials and Methods:
We recruited 57 participants from May 2022 through February 2023 using online advertisements. This multi-center, assessor-blinded, randomized, controlled exploratory trial used two groups: VR treatment group and treat as usual (TAU) group. VR treatment group received a VR mental health training/education program. TAU group received standard pharmacotherapy. Assessments were conducted at baseline, immediately after the 6-week treatment period, and 4 weeks after the end of the treatment period in each group.
Results:
Depression scores decreased significantly over time in both VR treatment and TAU groups, with no differences between the two groups. The suicidality score decreased significantly only in VR group. No group differences were found in the remission or response rate for depression, perceived stress, or clinical severity. No adverse events or motion sickness occurred during the VR treatment program.
Conclusion
VR CBT treatment for major depressive disorder has the potential to be equivalent to the gold-standard pharmacotherapy in reducing depressive symptoms, suicidality, and related clinical symptoms, with no difference in improvement found in this study. Thus, VR-based CBT might be an effective alternative to pharmacotherapy for depressive disorders.
4.Virtual Reality-Based Cognitive Behavior Therapy for Major Depressive Disorder: An Alternative to Pharmacotherapy for Reducing Suicidality
Miwoo LEE ; Sooah JANG ; Hyun Kyung SHIN ; Sun-Woo CHOI ; Hyung Taek KIM ; Jihee OH ; Ji Hye KWON ; Youngjun CHOI ; Suzi KANG ; In-Seong BACK ; Jae-Ki KIM ; San LEE ; Jeong-Ho SEOK
Yonsei Medical Journal 2025;66(1):25-36
Purpose:
Cognitive behavioral therapy (CBT) has long been recognized as an effective treatment for depression and suicidality.Virtual reality (VR) technology is widely used for cognitive training for conditions such as anxiety disorder and post-traumatic stress disorder, but little research has considered VR-based CBT for depressive symptoms and suicidality. We tested the effectiveness and safety of a VR-based CBT program for depressive disorders.
Materials and Methods:
We recruited 57 participants from May 2022 through February 2023 using online advertisements. This multi-center, assessor-blinded, randomized, controlled exploratory trial used two groups: VR treatment group and treat as usual (TAU) group. VR treatment group received a VR mental health training/education program. TAU group received standard pharmacotherapy. Assessments were conducted at baseline, immediately after the 6-week treatment period, and 4 weeks after the end of the treatment period in each group.
Results:
Depression scores decreased significantly over time in both VR treatment and TAU groups, with no differences between the two groups. The suicidality score decreased significantly only in VR group. No group differences were found in the remission or response rate for depression, perceived stress, or clinical severity. No adverse events or motion sickness occurred during the VR treatment program.
Conclusion
VR CBT treatment for major depressive disorder has the potential to be equivalent to the gold-standard pharmacotherapy in reducing depressive symptoms, suicidality, and related clinical symptoms, with no difference in improvement found in this study. Thus, VR-based CBT might be an effective alternative to pharmacotherapy for depressive disorders.
5.Virtual Reality-Based Cognitive Behavior Therapy for Major Depressive Disorder: An Alternative to Pharmacotherapy for Reducing Suicidality
Miwoo LEE ; Sooah JANG ; Hyun Kyung SHIN ; Sun-Woo CHOI ; Hyung Taek KIM ; Jihee OH ; Ji Hye KWON ; Youngjun CHOI ; Suzi KANG ; In-Seong BACK ; Jae-Ki KIM ; San LEE ; Jeong-Ho SEOK
Yonsei Medical Journal 2025;66(1):25-36
Purpose:
Cognitive behavioral therapy (CBT) has long been recognized as an effective treatment for depression and suicidality.Virtual reality (VR) technology is widely used for cognitive training for conditions such as anxiety disorder and post-traumatic stress disorder, but little research has considered VR-based CBT for depressive symptoms and suicidality. We tested the effectiveness and safety of a VR-based CBT program for depressive disorders.
Materials and Methods:
We recruited 57 participants from May 2022 through February 2023 using online advertisements. This multi-center, assessor-blinded, randomized, controlled exploratory trial used two groups: VR treatment group and treat as usual (TAU) group. VR treatment group received a VR mental health training/education program. TAU group received standard pharmacotherapy. Assessments were conducted at baseline, immediately after the 6-week treatment period, and 4 weeks after the end of the treatment period in each group.
Results:
Depression scores decreased significantly over time in both VR treatment and TAU groups, with no differences between the two groups. The suicidality score decreased significantly only in VR group. No group differences were found in the remission or response rate for depression, perceived stress, or clinical severity. No adverse events or motion sickness occurred during the VR treatment program.
Conclusion
VR CBT treatment for major depressive disorder has the potential to be equivalent to the gold-standard pharmacotherapy in reducing depressive symptoms, suicidality, and related clinical symptoms, with no difference in improvement found in this study. Thus, VR-based CBT might be an effective alternative to pharmacotherapy for depressive disorders.
6.Virtual Reality-Based Cognitive Behavior Therapy for Major Depressive Disorder: An Alternative to Pharmacotherapy for Reducing Suicidality
Miwoo LEE ; Sooah JANG ; Hyun Kyung SHIN ; Sun-Woo CHOI ; Hyung Taek KIM ; Jihee OH ; Ji Hye KWON ; Youngjun CHOI ; Suzi KANG ; In-Seong BACK ; Jae-Ki KIM ; San LEE ; Jeong-Ho SEOK
Yonsei Medical Journal 2025;66(1):25-36
Purpose:
Cognitive behavioral therapy (CBT) has long been recognized as an effective treatment for depression and suicidality.Virtual reality (VR) technology is widely used for cognitive training for conditions such as anxiety disorder and post-traumatic stress disorder, but little research has considered VR-based CBT for depressive symptoms and suicidality. We tested the effectiveness and safety of a VR-based CBT program for depressive disorders.
Materials and Methods:
We recruited 57 participants from May 2022 through February 2023 using online advertisements. This multi-center, assessor-blinded, randomized, controlled exploratory trial used two groups: VR treatment group and treat as usual (TAU) group. VR treatment group received a VR mental health training/education program. TAU group received standard pharmacotherapy. Assessments were conducted at baseline, immediately after the 6-week treatment period, and 4 weeks after the end of the treatment period in each group.
Results:
Depression scores decreased significantly over time in both VR treatment and TAU groups, with no differences between the two groups. The suicidality score decreased significantly only in VR group. No group differences were found in the remission or response rate for depression, perceived stress, or clinical severity. No adverse events or motion sickness occurred during the VR treatment program.
Conclusion
VR CBT treatment for major depressive disorder has the potential to be equivalent to the gold-standard pharmacotherapy in reducing depressive symptoms, suicidality, and related clinical symptoms, with no difference in improvement found in this study. Thus, VR-based CBT might be an effective alternative to pharmacotherapy for depressive disorders.
7.Carrier Frequency and Incidence of MUTYH-Associated Polyposis Based on Database Analysis in East Asians and Koreans
Jong Eun PARK ; Taeheon LEE ; Eun Hye CHO ; Mi-Ae JANG ; Dongju WON ; Boyoung PARK ; Chang-Seok KI ; Sun-Young KONG
Annals of Laboratory Medicine 2025;45(1):77-84
Background:
MUTYH-associated polyposis is an autosomal recessive disorder associated with an increased lifetime risk of colorectal cancer and a moderately increased risk of ovarian, bladder, breast, and endometrial cancers. We analyzed the carrier frequency and estimated the incidence of MUTYH-associated polyposis in East Asian and Korean populations, for which limited data were previously available.
Methods:
We examined 125,748 exomes from the gnomAD database, including 9,197 East Asians, and additional data from 5,305 individuals in the Korean Variant Archive and 1,722 in the Korean Reference Genome Database. All MUTYH variants were interpreted according to the American College of Medical Genetics and Genomics and Association for Molecular Pathology guidelines and the Sequence Variant Interpretation guidelines from ClinGen.
Results:
The global carrier frequency of MUTYH-associated polyposis was 1.29%, with Europeans (non-Finnish) having the highest frequency of 1.86% and Ashkenazi Jews the lowest at 0.06%. East Asians and Koreans had a carrier frequency of 0.35% and 0.37% and an estimated incidence of 1 in 330,409 and 1 in 293,304 in Koreans, respectively, which were substantially lower than the global average of 1 in 24,160 and the European (nonFinnish) incidence of 1 in 11,520.
Conclusions
This was the first study to investigate the frequency of carriers of MUTYH-associated polyposis in East Asians, including specific subgroups, utilizing gnomAD and a Korean genome database. Our data provide valuable reference information for future investigations of MUTYH-associated polyposis to understand the genetic diversity and specific variants associated with this condition in East Asian populations.
8.Medication-related osteonecrosis of the jaw: an evidence-based 2025position statement from a Korean multidisciplinary task force
Jin-Woo KIM ; Sung-Hye KONG ; Jae-Young KIM ; Mi Kyung KWAK ; Jun-Young KIM ; Ji-Hyeon OH ; Hyung-Youl PARK ; BeomTaek KIM ; Young-Kyun LEE ; Jeong Joon HAN ; Moon-Young KIM ; Yong Jun CHOI ; Yong-Dae KWON ; Kwang-Sup SONG ; Beom-Jun KIM ; Sun-Jong KIM ; Seung-Hoon BAEK ; Dong Ock LEE ; Han Seok CHOI ; Ha Young KIM ; Tae-Geon KWON ;
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2025;51(6):333-353
With a rapidly aging population and increasing use of antiresorptive agents, medication-related osteonecrosis of the jaw (MRONJ) represents a growing clinical challenge worldwide. To address the need for tailored clinical guidance, a multidisciplinary task force was convened. Five Korean academic societies—the Korean Society for Bone and Mineral Research, the Korean Association of Oral and Maxillofacial Surgeons, the Korean Association of Maxillofacial Plastic and Reconstructive Surgeons, the Korean Society of Osteoporosis, and the Korean Endocrine Society—collaborated to develop this position statement. The consensus was formulated through comprehensive reviews of literature, combined with three rounds of formal surveys to consolidate expert opinion on controversial topics. This position paper provides evidence-based clinical guidelines for the prevention, diagnosis, and management of MRONJ tailored to the Korean healthcare environment. The diagnostic criteria affirm the standard definition but add a provision for diagnosis based on clinical or radiographic evidence of necrotic bone, even if the traditional 8-week timeframe has not been met. The committee advocates for retaining Stage 0 in the staging system to emphasize early detection and preventive intervention. Key recommendations include prescriptive, drug-specific guidelines for prophylactic drug holidays (e.g., a 2-month pause for oral bisphosphonates; timing surgery 3-4 months after the last denosumab injection) to minimize MRONJ risk from dental procedures. This statement also provides a clear framework for therapeutic drug holidays in established MRONJ, carefully balancing the need for jaw healing against systemic fracture risk. For treatment, this statement advocates for early and active surgical intervention across all MRONJ stages, supported by evidence of superior long-term outcomes compared to conservative management.This position statement offers a unique, evidence-based Korean clinical practice guideline for managing MRONJ. It is intended to standardize care, reduce clinical confusion, and ultimately improve patient outcomes by providing a clear framework for decision-making.
9.The impact of body mass index on mortality according to age in hemodialysis patients: an analysis of the Korean Renal Data System
Hyunglae KIM ; Seon A JEONG ; Yoonjung CHO ; Kyeong Min KIM ; Sun Deuk HWANG ; Sun Ryoung CHOI ; Hajeong LEE ; Ji Hyun KIM ; Su Hyun KIM ; Tae Hee KIM ; Ho-Seok KOO ; Chang-Yun YOON ; Kiwon KIM ; Seon Ho AHN ; Hye Eun YOON ; Tae Hyun BAN ; Yu Ah HONG ; Yong Kyun KIM
Kidney Research and Clinical Practice 2025;44(2):217-227
The impact of age on the relationship between body mass index (BMI) and all-cause mortality in hemodialysis (HD) patients is not clearly understood. Using data from the Korean Renal Data System (2001–2022), we analyzed 66,129 HD patients, stratified into young (<65 years, n = 24,589), younger-old (65–74 years, n = 17,732), and older-old (≥75 years, n = 23,808) groups. Patients were categorized into BMI quartiles, and survival outcomes were evaluated using Kaplan-Meier curves and event time ratios for the relative change in the survival time. During the follow-up period, 14,360 of the patients (21.7%) died, with a median follow-up of 3.4 years. Kaplan-Meier curves revealed poorer outcomes in lower BMI quartiles across all age groups. The lowest BMI quartile was significantly associated with a shorter survival time compared to the highest BMI quartile, with a 15% reduction in the young group (p = 0.001) and a 12% reduction in the older-old group (p = 0.002). Predicted survival time increases with rising BMI in the young group, but the rate of increase slows in the younger-old group and plateaus in the older-old group after a BMI of 25 kg/m2. Lower BMI correlates with higher mortality, particularly in younger HD patients.
10.Medication-Related Osteonecrosis of the Jaw: An Evidence-Based 2025 Position Statement from a Korean Multidisciplinary Task Force
Jin-Woo KIM ; Sung-Hye KONG ; Jae-Young KIM ; Mi Kyung KWAK ; Jun-Young KIM ; Ji-Hyeon OH ; Hyung-Youl PARK ; BeomTaek KIM ; Young-Kyun LEE ; Jeong Joon HAN ; Moon-Young KIM ; Yong Jun CHOI ; Yong-Dae KWON ; Kwang-Sup SONG ; Beom-Jun KIM ; Sun-Jong KIM ; Seung-Hoon BAEK ; Dong Ock LEE ; Han Seok CHOI ; Ha Young KIM ; Tae-Geon KWON
Endocrinology and Metabolism 2025;40(6):787-810
With a rapidly aging population and increasing use of antiresorptive agents, medication-related osteonecrosis of the jaw (MRONJ) represents a growing clinical challenge worldwide. To address the need for tailored clinical guidance, a multidisciplinary task force was convened. Five Korean academic societies—the Korean Society for Bone and Mineral Research, the Korean Association of Oral and Maxillofacial Surgeons, the Korean Society of Maxillofacial Plastic and Reconstructive Surgeons, the Korean Osteoporosis Society, and the Korean Endocrine Society—collaborated to develop this position statement. The consensus was formulated through comprehensive reviews of literature, combined with three rounds of formal surveys to consolidate expert opinion on controversial topics. This position paper provides evidence-based clinical guidelines for the prevention, diagnosis, and management of MRONJ tailored to the Korean healthcare environment. The diagnostic criteria affirm the standard definition but add a provision for diagnosis based on clinical or radiographic evidence of necrotic bone, even if the traditional 8-week timeframe has not been met. The committee advocates for retaining stage 0 in the staging system to emphasize early detection and preventive intervention. Key recommendations include prescriptive, drug-specific guidelines for prophylactic drug holidays (e.g., a 2-month pause for oral bisphosphonates; timing surgery 3 to 4 months after the last denosumab injection) to minimize MRONJ risk from dental procedures. This statement also provides a clear framework for therapeutic drug holidays in established MRONJ, carefully balancing the need for jaw healing against systemic fracture risk. For treatment, this statement advocates for early and active surgical intervention across all MRONJ stages, supported by evidence of superior long-term outcomes compared to conservative management. This position statement offers a unique, evidence-based Korean clinical practice guideline for managing MRONJ. It is intended to standardize care, reduce clinical confusion, and ultimately improve patient outcomes by providing a clear framework for decision-making.

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