1.Efficacy and Safety of Low-Dose (0.2 mg) Dutasteride for Male Androgenic Alopecia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial
Subin LEE ; Jung Eun KIM ; Bark-Lynn LEW ; Chang Hun HUH ; Jandee KIM ; Ohsang KWON ; Moon Bum KIM ; Yang Won LEE ; Young LEE ; Jin PARK ; Sangseok KIM ; Do Young KIM ; Gwang Seong CHOI ; Hoon KANG
Annals of Dermatology 2025;37(4):183-190
Background:
Dutasteride, a 5-alpha reductase inhibitor, is prescribed for male androgenetic alopecia (AGA) in Korea and Japan. Despite its efficacy, its use is limited by its long half-life, potent dihydrotestosterone suppression, and adverse effects.
Objective:
To investigate the efficacy and safety of 0.2 mg dutasteride for male AGA.
Methods:
Patients with male AGA were randomized to receive 0.2 mg dutasteride, placebo, or 0.5 mg dutasteride (2:2:1) once daily for 24 weeks. Safety and efficacy endpoints were assessed.
Results:
Overall, 139 men were analyzed. At week 24, the change in hair count within the target area at the vertex from baseline was significantly higher in the 0.2 mg dutasteride group than in the placebo group (21.53 vs. 5.96, p=0.0072). Dutasteride (0.2 mg) treatment led to greater hair growth improvement, as assessed by investigators at week 24 (p=0.0096) and an independent panel at weeks 12 and 24 (p=0.0306, p=0.0001). For all efficacy endpoints, 0.2 mg dutasteride was as effective as 0.5 mg dutasteride. The incidence of adverse events was low and not statistically different between the 0.2 mg dutasteride and placebo groups. The limitation of this study is the limited number of participants.
Conclusion
Low-dose (0.2 mg) dutasteride for male AGA showed significant efficacy and favorable safety profile.Trial Registration: ClinicalTrials.gov Identifier: NCT04825561
2.Disease Awareness, Medical Use Behavior, Diagnosis and Treatment Status, Quality of Life and Comorbidities in Primary Cicatricial Alopecia Patients: A Multicenter Survey
Seo Won SONG ; Dong Geon LEE ; Hoon KANG ; Bark-Lynn LEW ; Jee Woong CHOI ; Ohsang KWON ; Yang Won LEE ; Beom Joon KIM ; Young LEE ; Jin PARK ; Moon-Bum KIM ; Do Young KIM ; Sang Seok KIM ; Byung Cheol PARK ; Sang Hoon LEE ; Gwang Seong CHOI ; Hyun-Tae SHIN ; Chang Hun HUH ; Yong Hyun JANG ; Soo Hong SEO ; Jiehyun JEON ; Hyun Sun PARK ; Chong Hyun WON ; Min Sung KIM ; Byung In RO ; Ji Hyun LEE ; Ji Hae LEE ; Dong Soo YU ; Yu Ri WOO ; Hyojin KIM ; Jung Eun KIM
Korean Journal of Dermatology 2024;62(4):206-217
Background:
Primary cicatricial alopecia (PCA) is a rare disease that causes irreversible destruction of hair follicles and affects the quality of life (QOL).
Objective:
We aimed to investigate the disease awareness, medical use behavior, QOL, and real-world diagnosis and treatment status of patients with PCA.
Methods:
A self-administered questionnaire was administered to patients with PCA and their dermatologists. Patients aged between 19 and 75 years who visited one of 27 dermatology departments between September 2021 and September 2022 were included.
Results:
In total, 274 patients were included. The male-to-female ratio was 1:1.47, with a mean age of 45.7 years. Patients with neutrophilic and mixed PCA were predominantly male and younger than those with lymphocytic PCA. Among patients with lymphocytic PCA, lichen planopilaris was the most common type, and among those with neutrophilic PCA, folliculitis decalvans was the most common type. Among the total patients, 28.8% were previously diagnosed with PCA, 47.0% were diagnosed with PCA at least 6 months after their first hospital visit, 20.0% received early treatment within 3 months of disease onset, and 54.4% received steady treatment. More than half of the patients had a moderate to severe impairment in QOL. Topical/intralesional steroid injections were the most common treatment. Systemic immunosuppressants were frequently prescribed to patients with lymphocytic PCA, and antibiotics were mostly prescribed to patients with neutrophilic PCA.
Conclusion
This study provides information on the disease awareness, medical use behavior, QOL, diagnosis, and treatment status of Korean patients with PCA. This can help dermatologists educate patients with PCA to understand the necessity for early diagnosis and steady treatment.
3.Validation and Reliability of the Cataract-related Visual Function Questionnaire (CVFQ)
Eun Jin KOH ; Jong Min LEE ; Dong Hui LIM ; Danbee KANG ; Juhee CHO ; Min Kyung SONG ; In Kwon CHUNG ; Hun Jin CHOI ; Ji Woong CHANG ; Jong Hyun LEE ; Tae Young CHUNG ; Young Sub EOM ; Yeoun Sook CHUN ; So Hyang CHUNG ; Eun Chul KIM ; Joon Young HYON ; Do Hyung LEE
Journal of the Korean Ophthalmological Society 2023;64(11):1030-1040
Purpose:
To evaluate the reliability and validity of the Cataract-related Visual Function Questionnaire (CVFQ).
Methods:
A prospective cross-sectional study of 141 cataract patients was conducted from March 2022 to June 2022. The questionnaire was created based on a literature review and advice from an expert panel. This study determined its construct validity, criterion validity, internal consistency, and test-retest reliability.
Results:
The CVFQ consists of 15 items distributed among five categories: overall visual quality, overall visual function, distance vision, near vision, and glare. In the exploratory factor analysis of validity, the first three principal components explained 77.8% of the variance. The p-values in the Spearman correlation test comparing the pre- and postoperative total CVFQ score and best-corrected visual acuity (BCVA) were 0.006 and 0.004, respectively. In the reliability analysis, Cronbach’s alpha was > 0.9 for internal consistency and the p-values of each subcategory were all significant in the analysis of test-retest reliability.
Conclusions
Our results indicate that the CVFQ is useful for measuring the visual quality and visual function of cataract patients in Korea.
4.Impact of Pediatric Alopecia Areata on Quality of Life of Patients and Their Family Members: A Nationwide Multicenter Questionnaire Study
Jee Woong CHOI ; Yul Hee KIM ; Hyunbin KWAK ; Jin PARK ; Won-Soo LEE ; Hoon KANG ; Jung Eun KIM ; Tae-Young YOON ; Ki-Ho KIM ; Yong Hyun JANG ; Do Won KIM ; Moon-Bum KIM ; Bark-Lynn LEW ; Woo-Young SIM ; Jiehyun JEON ; Soo Hong SEO ; Ohsang KWON ; Chang-Hun HUH ; Dong-Youn LEE ; Yang Won LEE ; Byung Choel PARK ; Chong Hyun WON ; Do Young KIM ; Hyojin KIM ; Beom Joon KIM ; Young LEE ; Sang Seok KIM ; Gwang Seong CHOI ; The Korean Hair Research Society
Annals of Dermatology 2022;34(4):237-244
Background:
Pediatric alopecia areata (AA) can affect the quality of life (QoL) of patients and their family members. Research on the QoL and burden on family members in pediatric AA is limited.
Objective:
This nationwide multicenter questionnaire study described the QoL and burden of the family members of patients with pediatric AA.
Methods:
This nationwide multicenter questionnaire study enrolled AA patients between the ages of 5 and 18 years from March 1, 2017 to February 28, 2018. Enrolled patients and their parents completed the modified Children’s Dermatology Life Quality Index (CDLQI) and the modified Dermatitis Family Impact (mDFI). The disease severity was measured using the Severity of Alopecia Tool (SALT) survey scores.
Results:
A total of 268 patients with AA from 22 hospitals participated in this study. Our study found that the efficacy and satisfaction of previous treatments of AA decreased as the severity of the disease increased. The use of home-based therapies and traditional medicines increased with the increasing severity of the disease, but the efficacy felt by patients was limited. CDLQI and mDFI scores were higher in patients with extensive AA than those with mild to moderate AA. The economic and time burden of the family members also increased as the severity of the disease increased.
Conclusion
The severity of the AA is indirectly proportional to the QoL of patients and their family members and directly proportional to the burden. Physicians need to understand these characteristics of pediatric AA and provide appropriate intervention to patients and their family members.
5.Targeting Hypoxia Using Evofosfamide and Companion Hypoxia Imaging of FMISO-PET in Advanced Biliary Tract Cancer
Jeesun YOON ; Seo Young KANG ; Kyung-Hun LEE ; Gi Jeong CHEON ; Do-Youn OH
Cancer Research and Treatment 2021;53(2):471-479
Purpose:
Hypoxia is widely known as one of the mechanisms of chemoresistance and as an environmental condition which triggers invasion and metastasis of cancer. Evofosfamide is a hypoxia-activated prodrug of the cytotoxin bromo-isophosphoramide mustard conjugated with 2-nitroimidazole. Biliary tract cancer (BTC) is known to contain large hypoxic area. This study evaluated the efficacy and safety of evofosfamide as a second-line treatment of advanced BTC.
Materials and Methods:
Patients received evofosfamide at a dose of 340 mg/m2 on days 1, 8, and 15 of every 28-day cycle. Primary end-point was progression-free survival (PFS) rate at 4-months (4m-PFSR). Secondary end-points included overall survival (OS), PFS, disease control rate (DCR), metabolic response by 18F-fluorodeoxyglucose positron emission tomography (PET), hypoxic parameters evaluated by 18F-fluoromisonidazole (FMISO) PET and toxicity.
Results:
Twenty patients were treated with evofosfamide, with 16 response-evaluable patients. There was no objective response; stable disease was observed in nine patients, with a DCR of 56.25%. 4m-PFSR was 40.6%. Median PFS was 3.60 months (95% confidence interval [CI], 1.68 to 5.52). Median OS was 6.37 months (95% CI, 3.94 to 8.79). Reduction of tumor metabolic activity was observed in eight of 15 patients (53.3%). High baseline hypoxic parameters were associated with poor PFS. Change of hypoxic parameters between pretreatment and post-treatment reflected hypoxic-activated drug response. There was no treatment-related death.
Conclusion
Evofosfamide as second-line treatment of advanced BTC showed acceptable safety and comparable efficacy to other agents. Changes in volumetric parameters measured with FMISO PET, showing the degree of tumor hypoxia, reflected the response to evofosfamide based on the mode of action.
6.Prognostic Value of Alpha-Fetoprotein in Patients Who Achieve a Complete Response to Transarterial Chemoembolization for Hepatocellular Carcinoma
Jae Seung LEE ; Young Eun CHON ; Beom Kyung KIM ; Jun Yong PARK ; Do Young KIM ; Sang Hoon AHN ; Kwang-Hyub HAN ; Wonseok KANG ; Moon Seok CHOI ; Geum-Youn GWAK ; Yong-Han PAIK ; Joon Hyeok LEE ; Kwang Cheol KOH ; Seung Woon PAIK ; Hwi Young KIM ; Tae Hun KIM ; Kwon YOO ; Yeonjung HA ; Mi Na KIM ; Joo Ho LEE ; Seong Gyu HWANG ; Soon Sun KIM ; Hyo Jung CHO ; Jae Youn CHEONG ; Sung Won CHO ; Seung Ha PARK ; Nae-Yun HEO ; Young Mi HONG ; Ki Tae YOON ; Mong CHO ; Jung Gil PARK ; Min Kyu KANG ; Soo Young PARK ; Young Oh KWEON ; Won Young TAK ; Se Young JANG ; Dong Hyun SINN ; Seung Up KIM ;
Yonsei Medical Journal 2021;62(1):12-20
Purpose:
Alpha-fetoprotein (AFP) is a prognostic marker for hepatocellular carcinoma (HCC). We investigated the prognostic value of AFP levels in patients who achieved complete response (CR) to transarterial chemoembolization (TACE) for HCC.
Materials and Methods:
Between 2005 and 2018, 890 patients with HCC who achieved a CR to TACE were recruited. An AFP responder was defined as a patient who showed elevated levels of AFP (>10 ng/mL) during TACE, but showed normalization or a >50% reduction in AFP levels after achieving a CR.
Results:
Among the recruited patients, 569 (63.9%) with naïve HCC and 321 (36.1%) with recurrent HCC after complete resection were treated. Before TACE, 305 (34.3%) patients had multiple tumors, 219 (24.6%) had a maximal tumor size >3 cm, and 22 (2.5%) had portal vein tumor thrombosis. The median AFP level after achieving a CR was 6.36 ng/mL. After a CR, 473 (53.1%) patients experienced recurrence, and 417 (46.9%) died [median progression-free survival (PFS) and overall survival (OS) of 16.3 and 62.8 months, respectively]. High AFP levels at CR (>20 ng/mL) were independently associated with a shorter PFS [hazard ratio (HR)=1.403] and OS (HR=1.284), together with tumor multiplicity at TACE (HR=1.518 and 1.666, respectively). AFP non-responders at CR (76.2%, n=359 of 471) showed a shorter PFS (median 10.5 months vs. 15.5 months, HR=1.375) and OS (median 41.4 months vs. 61.8 months, HR=1.424) than AFP responders (all p=0.001).
Conclusion
High AFP levels and AFP non-responders were independently associated with poor outcomes after TACE. AFP holds clinical implications for detailed risk stratification upon achieving a CR after TACE.
7.Targeting Hypoxia Using Evofosfamide and Companion Hypoxia Imaging of FMISO-PET in Advanced Biliary Tract Cancer
Jeesun YOON ; Seo Young KANG ; Kyung-Hun LEE ; Gi Jeong CHEON ; Do-Youn OH
Cancer Research and Treatment 2021;53(2):471-479
Purpose:
Hypoxia is widely known as one of the mechanisms of chemoresistance and as an environmental condition which triggers invasion and metastasis of cancer. Evofosfamide is a hypoxia-activated prodrug of the cytotoxin bromo-isophosphoramide mustard conjugated with 2-nitroimidazole. Biliary tract cancer (BTC) is known to contain large hypoxic area. This study evaluated the efficacy and safety of evofosfamide as a second-line treatment of advanced BTC.
Materials and Methods:
Patients received evofosfamide at a dose of 340 mg/m2 on days 1, 8, and 15 of every 28-day cycle. Primary end-point was progression-free survival (PFS) rate at 4-months (4m-PFSR). Secondary end-points included overall survival (OS), PFS, disease control rate (DCR), metabolic response by 18F-fluorodeoxyglucose positron emission tomography (PET), hypoxic parameters evaluated by 18F-fluoromisonidazole (FMISO) PET and toxicity.
Results:
Twenty patients were treated with evofosfamide, with 16 response-evaluable patients. There was no objective response; stable disease was observed in nine patients, with a DCR of 56.25%. 4m-PFSR was 40.6%. Median PFS was 3.60 months (95% confidence interval [CI], 1.68 to 5.52). Median OS was 6.37 months (95% CI, 3.94 to 8.79). Reduction of tumor metabolic activity was observed in eight of 15 patients (53.3%). High baseline hypoxic parameters were associated with poor PFS. Change of hypoxic parameters between pretreatment and post-treatment reflected hypoxic-activated drug response. There was no treatment-related death.
Conclusion
Evofosfamide as second-line treatment of advanced BTC showed acceptable safety and comparable efficacy to other agents. Changes in volumetric parameters measured with FMISO PET, showing the degree of tumor hypoxia, reflected the response to evofosfamide based on the mode of action.
8.Postoperative changes in the pharyngeal airway space through computed tomography evaluation after mandibular setback surgery in skeletal class III patients: 1-year follow-up
No Eul KANG ; Dae Hun LEE ; Ja In SEO ; Jeong Keun LEE ; Seung Il SONG
Maxillofacial Plastic and Reconstructive Surgery 2021;43(1):31-
Background:
This study evaluated the pharyngeal airway space changes up to 1 year after bilateral sagittal split osteotomy mandibular setback surgery and bimaxillary surgery with maxillary posterior impaction through threedimensional computed tomography analysis.
Methods:
A total of 37 patients diagnosed with skeletal class III malocclusion underwent bilateral sagittal split osteotomy setback surgery only (group 1, n = 23) or bimaxillary surgery with posterior impaction (group 2,n = 14).Cone-beam computed tomography scans were taken before surgery (T0), 2 months after surgery (T1), 6 months after surgery (T2), and 1 year after surgery (T3). The nasopharynx (Nph), oropharynx (Oph), hypopharynx (Hph) volume, and anteroposterior distance were measured through the InVivo Dental Application version 5.
Results:
In group 1, Oph AP, Oph volume, Hph volume, and whole pharynx volume were significantly decreased after the surgery (T1) and maintained. In group 2, Oph volume and whole pharynx volume were decreased (T2) and relapsed at 1 year postoperatively (T3).
Conclusion
In class III malocclusion patients, mandibular setback surgery only showed a greater reduction in pharyngeal airway than bimaxillary surgery at 1 year postoperatively, and bimaxillary surgery was more stable in terms of airway. Therefore, it is important to evaluate the airway before surgery and include it in the surgical plan.
9.Efficacy and Safety of Pembrolizumab in Patients with RefractoryAdvanced Biliary Tract Cancer: Tumor Proportion Score as a PotentialBiomarker for Response
Junho KANG ; Jae Ho JEONG ; Hee-Sang HWANG ; Sang Soo LEE ; Do Hyun PARK ; Dong Wook OH ; Tae Jun SONG ; Ki-Hun KIM ; Shin HWANG ; Dae Wook HWANG ; Song Cheol KIM ; Jin-hong PARK ; Seung-Mo HONG ; Kyu-pyo KIM ; Baek-Yeol RYOO ; Changhoon YOO
Cancer Research and Treatment 2020;52(2):594-603
Purpose:
The current standard chemotherapy for advanced biliary tract cancer (BTC) has limited benefit,and novel therapies need to be investigated.
Materials and Methods:
In this prospective cohort study, programmed death ligand-1 (PD-L1)–positive BTC patientswho progressed on first-line gemcitabine plus cisplatin were enrolled. Pembrolizumab 200mg was administered intravenously every 3 weeks.
Results:
Between May 2018 and February 2019, 40 patients were enrolled. Pembrolizumab wasgiven as second-line (47.5%) or third-line therapy (52.5%). The objective response ratewas 10% and 12.5% by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 andimmune-modified RECIST (imRECIST) and median duration of response was 6.3 months.Among patients with progressive disease as best response, one patient (1/20, 5.0%)achieved complete response subsequently. The median progression-free survival (PFS) andoverall survival (OS) were 1.5 months (95% confidence interval [CI], 0.0 to 3.0) and 4.3months (95% CI, 3.5 to 5.1), respectively, and objective response per imRECIST was significantlyassociated with PFS (p < 0.001) and OS (p=0.001). Tumor proportion score 50%was significantly associated with higher response rates including the response after pseudoprogression(vs. < 50%; 37.5% vs. 6.5%; p=0.049).
Conclusion
Pembrolizumab showed modest anti-tumor activity in heavily pretreated PD-L1–positiveBTC patients. In patients who showed objective response, durable response could beachieved.
10.Effects of Paliperidone Palmitate on Healthcare Utilization and Costs for Patients with Schizophrenia: A Claim-based Mirror-image Study in South Korea
Dasom LEE ; Boung Chul LEE ; Soo-Hee CHOI ; Do-Hyung KANG ; Duk-In JON ; Myung Hun JUNG
Clinical Psychopharmacology and Neuroscience 2020;18(2):303-310
Objective:
Long-acting injectable (LAI) antipsychotics, such as paliperidone palmitate (PP), are known to improve treatment adherence in patients with schizophrenia, which can lead to reductions in relapse and hospitalization rates. However, relatively few studies have demonstrated the economic impact of LAIs, especially in Asian populations.
Methods:
We conducted a claim-based mirror-image study to explore changes in healthcare utilization and associated costs, among 1,272 South Korean patients with schizophrenia (ICD-10-CM code F20), between the 1-year periods before and after the initiation of PP treatment.
Results:
Patients accessed outpatient services more frequently after versus before starting PP treatment, with the number of prescription days increasing by 133.45 (p < 0.0001) and the associated costs increasing by USD 1,497.15 (p < 0.0001). The number of admission days was reduced by 11.33 after starting PP treatment (p < 0.0001) and the associated costs were reduced by USD 1,220.75 (p < 0.0001). However, admission cost savings were different according to patients’ oral drug compliance. The daily dosages for benztropine, procyclidine, and propranolol decreased, showing that there were fewer side-effects after PP-treatment (p < 0.0001).
Conclusion
Although the high acquisition cost of PP has been regarded as an obstacle to its clinical use, our results imply that the high prescription costs for PP may be counterbalanced by the reduced admission costs associated with its use. Economic outcomes for patients treated with LAIs should be investigated further to help healthcare decision-makers and providers to determine the value of LAIs relative to other treatment medications.

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