PURPOSE: Soft tissue coverage of the distal leg and ankle region represents a surgical challenge. Beside various local and free flaps, the perforator flap has recently been replaced as a reconstructive choice because of its functional and aesthetic superiority. Although posterior tibial artery perforator flap (PTAPF) has been reported less often than peroneal artery perforator flap, it also provides a reliable surgical option in small to moderate sized defects especially around the medial malleolar region. MATERIALS AND METHODS: Seven consecutive patients with soft tissue defect in the ankle and foot region were enrolled. After Doppler tracing along the posterior tibial artery, the PTAPF was elevated from the adjacent tissue. The average size of the flap was 28.08±9.31 cm² (range, 14.25 to 37.84 cm²). The elevated flap was acutely rotated or advanced. RESULTS: Six flaps survived completely but one flap showed partial necrosis because of overprediction of the perforasome. No donor site complications were observed during the follow-up period and all seven patients were satisfied with the final results. CONCLUSION: For a small to medium-sized defect in the lower leg, we conducted the close-by islanded PTAPF using a single proper adjacent perforator. Considering the weak point of the conventional propeller flap, this technique yields much better aesthetic results as a simple and reliable technique especially for defects of the medial malleolar region.
Ankle* ; Arteries ; Follow-Up Studies ; Foot ; Free Tissue Flaps ; Humans ; Leg ; Necrosis ; Perforator Flap* ; Surgical Flaps ; Tibial Arteries* ; Tissue Donors

Burn injury is one of the most common complications associated with laser procedure. A 38-year-old woman underwent laser procedure for skin rejuvenation on her neck at a local aesthetic clinic. At that time, the cooling system installed in the laser machine was out of order without known origin. The patient complained of pain during the procedure, but it was neglected. It resulted in 3(rd)-degree burn involving the subcutaneous fatty layer on her neck. On the fifth day after injury, early debridement and advancement flap was done under local anesthesia. After 7 days postoperatively, total stitch out was done and a 6cm-length linear and transverse scar remained. When deep dermal injury occurs, it will take a long time to heal on its own. Early debridement and advancement flap will be helpful to prevent wide burn scar.
Adult ; Anesthesia, Local ; Burns ; Cicatrix ; Debridement ; Female ; Humans ; Neck* ; Rejuvenation ; Skin

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.
Cardiovascular System ; Clinical Trials, Phase I as Topic ; Geographic Locations ; Korea ; Registries ; Seoul

BACKGROUND: Epoxy resin compounds are one of the common causes of occupational allergic contact dermatitis. In Korea, most cases of allergic contact dermatitis from epoxy resin compounds have been caused by the epoxy resin itself. We report a rare case of allergic contact dermatitis which was caused by epichlorohydrin, an ingredient of epoxy resin and 2,4,6-tris-(dimethylaminomethyl)phenol (tris-DMP), a kind of hardeners. CASE REPORT: A 43-year-old man, who had worked at the epoxy resin glue manufacturing factory since 1999, presented with mild and intermittent erythematous papules and rashes on his face, neck, trunk, and both arms. He was dealing with epoxy resin, epichlorohydrin, bisphenol A and hardeners. After a new hardener was added in August 2008, his skin lesions worsened from what he had experienced in the past. A skin patch test was performed to identify the causative chemicals of the skin lesion. Epichlorohydrin and tris-DMP elicited positive reactions after 48 hours and increased after 96 hours. CONCLUSION: This case confirmed occupational allergic contact dermatitis caused by epichlorohydrin and tris-DMP, an ingredient of epoxy resin and a hardener, respectively.
Adhesives ; Adult ; Arm ; Benzhydryl Compounds ; Dermatitis, Allergic Contact ; Epichlorohydrin ; Exanthema ; Humans ; Korea ; Neck ; Patch Tests ; Phenols ; Skin

A fixed-dose combination (FDC) of gemigliptin/metformin can improve the medication adherence in patients with type 2 diabetes mellitus (T2DM). In this study, the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of gemigliptin and metformin were compared between FDC and the corresponding loose combination under fasted and fed states. A two-part, randomized, open label, single-dose, two-way crossover study was conducted in healthy male subjects. Under fasted (part 1) or fed (part 2) state, 2 FDC tablets of gemigliptin/metformin sustained release (SR) 25/500 mg or loose combination with one tablet of gemigliptin 50 mg and two tablets of metformin extended release (XR) 500 mg were orally administered in each period with a 7-day washout. Serial blood samples were collected up to 48 hours to determine the drug concentration and the dipeptidyl peptidase 4 (DPP-4) activity. The concentration-time profiles of gemigliptin and metformin were similar between FDC and loose combination in both the fasted and fed states. Geometric mean ratios and 90% confidence intervals of FDC to loose combination for area under the concentration-time curve and maximum plasma concentration of gemigliptin and metformin were within the bioequivalence range (0.8–1.25) in both states. DPP-4 activity-time profiles of FDC were comparable to that of the loose combination, showing similar area under the DPP-4 inhibition-time curve and maximum DPP-4 inhibition between FDC and loose combination, regardless of the fasted or fed state. In conclusion, the PK/PD characteristics of gemigliptin and metformin were similar in FDC tablets and loose combination both in fasted and fed states.

P-glycoprotein (P-gp) is a transporter that plays an excretory role in epithelial cells. It is encoded by ABCB1, and single nucleotide polymorphisms (SNPs) in this gene can affect systemic drug exposure. Dapagliflozin and sitagliptin, used in type 2 diabetes treatment, are P-gp substrates. Here, we aimed to investigate whether ABCB1 polymorphisms affect dapagliflozin and sitagliptin pharmacokinetics (PK) in healthy Korean subjects.The study population consisted of 100 healthy Korean subjects (94 men and 6 women) who participated in four different clinical trials and received dapagliflozin and sitagliptin doses of 10 and 100 mg, respectively. We determined ABCB1 genotypes for the C3435T, C1236T, and G2677T/A SNPs. The relationship between the genotypes and dapagliflozin PKs was examined.Dapagliflozin and sitagliptin PK parameters were not statistically significantly affected by ABCB1 SNP genotypes. However, homozygous 3435TT subjects showed higher dapagliflozin PK parameters than CT and CC subjects. In subjects with the 3435TT and those with 3435CC and 3435CT genotypes, mean Cmax, AUCinf, and AUC0-1 values of dapagliflozin were 223.06 ng/mL and 194.81 ng /mL (p = 0.2767), 673.58 ng*h/mL and 573.96 ng*h/mL (p = 0.0492), and 128.53 ng*h/mL and 104.61 ng*h/mL (p = 0.2678), respectively.In summary, dapagliflozin and sitagliptin PK parameters were not significantly different between individuals with C1236T and C2677T/A ABCB1 genetic polymorphisms. Dapagliflozin exhibited higher systemic exposure in 3435TT subjects than in CC/CT subjects.

Proton-pump inhibitors (PPIs) are effectively used to treat acid-related diseases, including gastroesophageal reflux disease (GERD); however, many unmet medical needs still exist. As a new treatment option, potassium-competitive acid blockers (P-CABs), such as tegoprazan, have been developed. This study was performed to compare the pharmacokinetics (PKs) between two formulations (test and reference drugs) of tegoprazan 100 mg tablets. A randomized, single oral dose, two-treatment, two-period, two-sequence study was conducted with 12 healthy subjects. Each subject received the test drug or reference drug in the first period and the alternative treatment in the second period. For PK evaluation, blood samples were collected up to 48 hours post-dose in each period. The plasma concentrations of tegoprazan and its active metabolite (M1) were measured by liquid chromatography-tandem mass spectrometry. PK parameters, including maximum plasma concentration (C(max)) and area under the concentration-time curve from zero to the last measurable time (AUC(last)), were estimated using a non-compartmental method. The plasma concentration-time profiles of the two formulations were comparable. The geometric mean ratios [90% confidence intervals (CIs)] of the test drug to the reference drug for C(max) and AUC(last) were 0.98 (0.85–1.12) and 1.03 (0.93–1.13), respectively. The corresponding values of M1 were 0.99 (0.89–1.11) and 1.01 (0.93–1.09), respectively. The two formulations of tegoprazan exhibited comparable PK profiles, fulfilling the regulatory criteria for bioequivalence.
Gastroesophageal Reflux ; Healthy Volunteers ; Humans ; Male ; Mass Spectrometry ; Methods ; Pharmacokinetics ; Plasma ; Tablets ; Therapeutic Equivalency

Combination therapies of antihypertensive drugs are recommended in cases where hypertension is not controlled by monotherapy. This study aimed to compare the pharmacokinetics (PKs) between fixed-dose combination (FDC) of fimasartan/amlodipine 60/10 mg and the corresponding loose combination. Because of the high intra-subject variability for maximum plasma concentration (C(max)) of fimasartan, a randomized, open-label, 3×3 partial replicated crossover design was adopted. Subjects received a single dose of FDC of fimasartan/amlodipine 60/10 mg or the corresponding loose combination in each period. Blood samples for PK analysis were collected up to 48 hours for fimasartan and 144 hours for amlodipine, respectively. Geometric mean ratios (GMRs) and its 90% confidence intervals (CIs) of the FDC to the loose combination for C(max) and area under the concentration-time curve from time 0 to the last quantifiable time point (AUC(last)) were calculated. Sixty healthy subjects were randomized, and 57 subjects completed the study. The concentration-time profiles of fimasartan and amlodipine were similar between the FDC and loose combination. The GMRs (90% CIs) of the FDC to the loose combination for C(max) and AUC(last) were 1.0440 (0.9202–1.1844) and 1.0412 (0.9775–1.1090) for fimasartan, and 1.0430 (1.0156–1.0711) and 1.0339 (1.0055–1.0631) for amlodipine, respectively. The GMRs and its 90% CIs for C(max) and AUC(last) of fimasartan and amlodipine were included not only in the scaled bioequivalence criteria but also in the conventional bioequivalence criteria. In conclusion, FDC of fimasartan/amlodipine 60/10 mg showed comparable PK profiles with the corresponding loose combination, which suggests their bioequivalence.
Amlodipine ; Antihypertensive Agents ; Cross-Over Studies ; Healthy Volunteers ; Hypertension ; Pharmacokinetics ; Plasma ; Therapeutic Equivalency

This study aimed to compare the pharmacokinetics of fixed-dose combination (FDC) tablet of rosuvastatin 20 mg/ezetimibe 10 mg with that of concurrent administration of individual rosuvastatin 20 mg tablet and ezetimibe 10 mg tablet in healthy subjects. A randomized, open label, single-dose, two-way crossover study was conducted. Subjects randomly received test formulation (FDC tablet of rosuvastatin 20 mg/ezetimibe 10 mg) or reference formulation (co-administration of rosuvastatin 20 mg tablet and ezetimibe 10 mg tablet). After 2 weeks of washout, subjects received the other treatment. Blood samples were collected up to 72 hours post-dose in each period. Plasma concentrations of rosuvastatin, ezetimibe and total ezetimibe (ezetimibe + ezetimibe glucuronide) were analyzed by liquid chromatography-tandem mass spectrometry (LC/MS/MS). The geometric mean ratio (GMR) of Cmax and AUClast (90% confidence interval, CI) for rosuvastatin was 1.036 (0.979–1.096) and 1.024 (0.981–1.070), respectively. The corresponding values for ezetimibe were 0.963 (0.888–1.043) and 1.021 (0.969–1.074), respectively. The corresponding values for total ezetimibe were 0.886 (0.835–0.940) and 0.983 (0.946–1.022), respectively. FDC tablet containing rosuvastatin 20 mg and ezetimibe 10 mg is bioequivalent to the co-administration of commercially available individual tablets of rosuvastatin and ezetimibe as GMR with 90% CI of Cmax and AUClast of rosuvastatin, ezetimibe and total ezetimibe were contained within conventionally accepted bioequivalence criteria.
Cross-Over Studies ; Ezetimibe ; Healthy Volunteers ; Mass Spectrometry ; Pharmacokinetics ; Plasma ; Rosuvastatin Calcium ; Tablets ; Therapeutic Equivalency

Periprosthetic capsular contracture, implant rupture, and deflation are well-known delayed complications of augmentation mammaplasty. However, infection remains the most common cause of reoperation after breast implant surgery. We report the case of a nontuberculous mycobacterial infection with huge abscess formation after augmentation mammaplasty. A 29-year-old woman visited our clinic with enlarged breasts after undergoing breast augmentation at a local clinic 4 years ago. She had no pain and tenderness, except some hardness around the breast margin. Nine months after surgery, her breasts began to grow larger, but showed no other typical symptoms, which led the patient to neglect the enlargement. After exploring through an inframammary approach, a large amount of serous fluid leaked out on both sides and we identified a huge abscess in a pocket localized in the submuscular plane. During exploration, the infected implants, which contained a pus-like fluid with a foul odor, were completely drained. The specimen culture revealed growth of Mycobacterium abscessus, which is a rare cause of infections after breast augmentation. While the overall incidence of mycobacterial infections after breast augmentation is low, our case demonstrates that huge abscess and granuloma formation should be considered as a potential complication of breast surgery.
Abscess* ; Adult ; Breast Implantation ; Breast Implants ; Breast* ; Female ; Granuloma ; Hardness ; Humans ; Implant Capsular Contracture ; Incidence ; Mammaplasty ; Mycobacterium* ; Nontuberculous Mycobacteria ; Odors ; Reoperation ; Rupture