Kyung Hee University Dental Hospital

BACKGROUND: Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis. METHODS: We conducted two integrated randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active disease. In the trial of induction therapy, 374 patients (cohort 1) received vedolizumab (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients (cohort 2) received open-label vedolizumab at weeks 0 and 2, with disease evaluation at week 6. In the trial of maintenance therapy, patients in either cohort who had a response to vedolizumab at week 6 were randomly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks. A response was defined as a reduction in the Mayo Clinic score (range, 0 to 12, with higher scores indicating more active disease) of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. RESULTS: Response rates at week 6 were 47.1% and 25.5% among patients in the vedolizumab group and placebo group, respectively (difference with adjustment for stratification factors, 21.7 percentage points; 95% confidence interval [CI], 11.6 to 31.7; P<0.001). At week 52, 41.8% of patients who continued to receive vedolizumab every 8 weeks and 44.8% of patients who continued to receive vedolizumab every 4 weeks were in clinical remission (Mayo Clinic score ≤2 and no subscore >1), as compared with 15.9% of patients who switched to placebo (adjusted difference, 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [95% CI, 14.9 to 37.2; P<0.001] and 29.1 percentage points for vedolizumab every 4 weeks vs. placebo [95% CI, 17.9 to 40.4; P<0.001]). The frequency of adverse events was similar in the vedolizumab and placebo groups. CONCLUSIONS: Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis. (Funded by Millennium Pharmaceuticals; GEMINI 1 ClinicalTrials.gov number, NCT00783718.).

Recently, significant progress has been made in developing “stimuli-sensitive” biomaterials as a new therapeutic approach to interact with dynamic physiological conditions. Reactive oxygen species (ROS) production has been implicated in important pathophysiological events, such as atherosclerosis,aging, and cancer. ROS are often overproduced locally in diseased cells and tissues, and they individually and synchronously contribute to many of the abnormalities associated with local pathogenesis. Therefore, the advantages of developing ROS-responsive materials extend beyond site-specific targeting of therapeutic delivery, and potentially include navigating,sensing, and repairing the cellular damages via programmed changes in material properties. Here we review the mechanism and development of biomaterials with ROS-induced solubility switch or degradation, as well as their performance and potential for future biomedical applications.

OBJECTIVE: We prospectively evaluated transabdominal and transvaginal sonographic findings of patients with pelvic congestion syndrome and compared them with those of healthy volunteers. SUBJECTS AND METHODS. We examined 32 patients with pelvic congestion syndrome and 35 control subjects. Using transabdominal sonography, we evaluated the ovarian veins for diameter and flow direction, presence of pelvic varicocele, diameter of the pelvic veins, change of the duplex waveform during the Valsalva's maneuver, volume of the uterus, and presence of polycystic changes in the ovaries. We compared and statistically analyzed each parameter in the pelvic congestion syndrome group and in the control group. RESULTS: The mean (+/- SD) diameter of the left ovarian vein was 0.79 +/- 0.23 cm in the pelvic congestion syndrome group and 0.49 +/- 0.15 cm in the control group (p = 0.000). Reversed caudal flow in the left ovarian vein was present in 22 of 22 patients and in four of 16 control subjects. Pelvic varicoceles were present in all patients with pelvic congestion syndrome and in six control subjects. The mean diameter of the left pelvic vein was 0.68 +/- 0.21 cm in the pelvic congestion syndrome group and 0.42 +/- 0.19 cm in the control group; the mean diameter of the right pelvic vein was 0.64 +/- 0.24 cm in the pelvic congestion syndrome group and 0.35 +/- 0.14 cm in the control group (p = 0.000). Polycystic changes of the ovary were present in 13 patients with pelvic congestion syndrome (40.6%) and four control subjects (11.4%). CONCLUSION: Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization.

A hybrid hydrogel composed of gelatin and gold nanoparticles (GNPs) was designed to evaluate the effect of new bone formation and proves itself to be useful as an implant material for treating defected bone tissues.

OBJECTIVE: To evaluate the immediate effects of rapid maxillary expansion (RME) on the transverse skeletal and dentoalveolar changes with bone-borne (C-expander) and tooth-borne type expanders using cone-beam computed tomography (CBCT) in late adolescents. MATERIALS AND METHODS: A sample of 28 female late-adolescent patients was divided into two groups according to the type of expander: bone-borne (C-expander, n = 15, age = 18.1 ± 4.4 years) and tooth-borne (hyrax, bands on premolars and molars, n = 13, age = 17.4 ± 3.4 years). CBCT scans were taken at 0.2-mm voxel size before treatment (T1) and 3 months after RME (T2). Transverse skeletal and dental expansion, alveolar inclination, tooth axis, vertical height of tooth, and buccal dehiscence were evaluated on maxillary premolars and molars. Paired t-test, independent t-test, one-way analysis of variance, and Scheffé post hoc analysis were performed. RESULTS: The C-expander group produced greater skeletal expansion, except in the region of the first premolar (P < .05 or < .01), which showed slight buccal tipping of the alveolar bone. The Hyrax group had more buccal tipping of the alveolar bone and the tooth axes, except in the region of the second molar (P < .05 or < .01 or < .001). Dental expansion at the apex level was similar in the banded teeth (the first premolar and the first molar). Vertical height changes were apparent on the second premolar in the hyrax group (P < .05 or < .01). Significant buccal dehiscence occurred at the first premolar in the hyrax group (P < .01 or < .001). There were no significant differences between tooth types for any variables in the C-expander group. CONCLUSIONS: For patients in late adolescence, bone-borne expanders produced greater orthopedic effects and fewer dentoalveolar side effects compared to the hyrax expanders.

Aspiration-assisted bioprinting enables precise positioning of viscoelastic spheroids in both scaffold-based and free manner.

The impaired insulin secretion and increased insulin resistance (or decreased insulin sensitivity) play a major role in the pathogenesis of all types of diabetes mellitus (DM). It is very important to assess the pancreatic β-cell function and insulin resistance/ sensitivity to determine the type of DM and to plan an optimal management and prevention strategy for DM. So far, various methods and indices have been developed to assess the β-cell function and insulin resistance/sensitivity based on static, dynamic test and calculation of their results. In fact, since the metabolism of glucose and insulin is made through a complex process related with various stimuli in several tissues, it is difficult to fully reflect the real physiology. In order to solve the theoretical and practical difficulties, research on new index is still in progress. Also, it is important to select the appropriate method and index for the purpose of use and clinical situation. This review summarized a variety of traditional methods and indices to evaluate pancreatic β-cell function and insulin resistance/sensitivity and introduced novel indices.

In this study, we prepared a blended nanofiber scaffold using synthetic and natural polymers, polyurethane (PU) and gelatin respectively, using the electrospinning method to prepare a material for wound dressing. In order to confirm the properties of this gelatin/PU blended nanofiber scaffold, we performed scanning electron microscopy, atomic force microscopy, attenuated total reflectance Fourier-transform infrared spectroscopy, thermal gravimetric analysis, contact angle, water uptake, mechanical property, recovery, and degradation tests, and cellular response. The results obtained indicate that the mean diameter of these nanofibers was uniformly electrospun and ranged from 0.4 to 2.1 microm. According to the results, when the amount of gelatin in the blended solution decreased, the contact angle increased and water uptake of the scaffold decreased concurrently. In the mechanical tests, the blended nanofibrous scaffolds were elastic, and elasticity increased as the total amount of PU increased. Moreover, as the total amount of gelatin increased, the cell proliferation increased with the same amount of culture time. Therefore, this gelatin/PU blended nanofiber scaffold has potential application for use as a wound dressing.

Although melatonin has a variety of biological actions such as antitumor, antiangiogenic, and antioxidant activities, the osteogenic mechanism of melatonin still remains unclear. Thus, in the present study, the molecular mechanism of melatonin was elucidated in the differentiation of mouse osteoblastic MC3T3-E1 cells. Melatonin enhanced osteoblastic differentiation and mineralization compared to untreated controls in preosteoblastic MC3T3-E1 cells. Also, melatonin increased wound healing and dose-dependently activated osteogenesis markers such as runt-related transcription factor 2 (Runx2), osteocalcin (OCN), bone morphogenic protein (BMP)-2 and -4 in MC3T3-E1 cells. Of note, melatonin activated Wnt 5 α/β, β-catenin and the phosphorylation of c-Jun N-terminal kinase (JNK), and extracellular signal-regulated kinase (ERK) in a time-dependent manner while it attenuated phosphorylation of glycogen synthase kinase 3 beta (GSK-3β) in MC3T3-E1 cells. Consistently, confocal microscope observation revealed that BMP inhibitor Noggin blocked melatonin-induced nuclear localization of β-catenin. Furthermore, Western blotting showed that Noggin reversed activation of β-catenin and Wnt5 α/β and suppression of GSK-3β induced by melatonin in MC3T3-E1 cells, which was similarly induced by ERK inhibitor PD98059. Overall, these findings demonstrate that melatonin promotes osteoblastic differentiation and mineralization in MC3T3-E1 cells via the BMP/ERK/Wnt pathways.

PURPOSE: To retrospectively evaluate the diagnostic performance and complications of C-arm cone-beam computed tomography (CT)-guided percutaneous transthoracic needle biopsy (PTNB) in 1108 patients. MATERIALS AND METHODS: This retrospective study was approved by the institutional review board with waiver of patient informed consent. From January 2009 to December 2011, 1108 patients (633 male, 475 female; mean age, 62.4 years ± 12.3 [standard deviation]) with 1116 pulmonary lesions (mean size, 2.7 cm ± 1.7) underwent 1153 cone-beam CT-guided PTNBs. A coaxial system with 18-gauge cutting needles was used. Diagnostic performance, complication rate, influencing factors, and patient radiation exposure were investigated. Variables influencing diagnostic performance and complications were assessed by using uni- and multivariate logistic regression analyses. RESULTS: Among 1153 PTNBs, pathologic analysis showed 1148 (99.6%) were technically successful (766 malignant [66.4%], 323 benign [28.0%], and 59 [5.1%] indeterminate). Sensitivity, specificity, and accuracy for diagnosis of malignancy were 95.7% (733 of 766), 100% (323 of 323), and 97.0% (1056 of 1089), respectively. In regard to diagnostic failures (five technical failures, 33 false-negative findings), lesions 1 cm in diameter or smaller and lesions in the lower lobe were significant risk factors (P = .028 and P = .034, respectively). As for complications, pneumothorax and hemoptysis occurred in 196 (17.0%) and 80 (6.9%) procedures, respectively. Multivariate analysis revealed two or more pleural passages and emphysema along the needle pathway were the two most significant risk factors for pneumothorax, and ground-glass nodules were the most significant risk factor for hemoptysis (P < .001 for all). Virtual guidance was a significant protective factor for both pneumothorax and hemoptysis (P < .001 for both). Mean estimated effective radiation dose through cone-beam CT-guided PTNBs was 7.3 mSv ± 4.1. CONCLUSION: Cone-beam CT-guided PTNB is a highly accurate and safe technique with which to diagnose pulmonary lesions with reasonable radiation exposure.

Background— The initial EROSION study (Effective Anti-Thrombotic Therapy Without Stenting: Intravascular Optical Coherence Tomography–Based Management in Plaque Erosion) demonstrated that patients with acute coronary syndrome caused by plaque erosion might be stabilized with aspirin and ticagrelor without stenting for ≤1 month. However, a long-term evaluation of outcomes is lacking. The aim of this study was to assess whether the initial benefit of noninterventional therapy for patients with acute coronary syndrome caused by plaque erosion is maintained for ≤1 year. Methods and Results— Among 53 patients who completed clinical follow-up, 49 underwent repeat optical coherence tomography imaging at 1 year. Median residual thrombus volume decreased significantly from 1 month to 1 year (0.3 mm 3 (0.0–2.0 mm 3 ] versus 0.1 mm 3 [0.0–2.0 mm 3 ]; P =0.001). Almost half of the patients (46.9%) had no residual thrombus at 1 year. Minimal effective flow area remained unchanged (2.1 mm 2 [1.5–3.8 mm 2 ] versus 2.1 mm 2 [1.6–4.0 mm 2 ]; P =0.152). Among 53 patients, 49 (92.5%) remained free from major adverse cardiovascular event for ≤1 year: 3 (5.7%) patients required revascularization because of exertional angina and 1 (1.9%) patient had gastrointestinal bleeding. Conclusions— One-year follow-up optical coherence tomography demonstrated a further decrease in thrombus volume between 1-month and 1-year follow-up. A majority (92.5%) of patients with acute coronary syndrome caused by plaque erosion managed with aspirin and ticagrelor without stenting remained free of major adverse cardiovascular event for ≤1 year. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT02041650.

OBJECTIVES: Working Group 5 was assigned the task to review the current knowledge in the area of digital technologies. Focused questions on accuracy of linear measurements when using CBCT, digital vs. conventional implant planning, using digital vs. conventional impressions and assessing the accuracy of static computer-aided implant surgery (s-CAIS) and patient-related outcome measurements when using s-CAIS were addressed. MATERIALS AND METHODS: The literature was systematically searched, and in total, 232 articles were selected and critically reviewed following PRISMA guidelines. Four systematic reviews were produced in the four subject areas and amply discussed in the group. After emendation, they were presented to the plenary where after further modification, they were accepted. RESULTS: Static computer-aided surgery (s-CAIS), in terms of pain & discomfort, economics and intraoperative complications, is beneficial compared with conventional implant surgery. When using s-CAIS in partially edentulous cases, a higher level of accuracy can be achieved when compared to fully edentulous cases. When using an intraoral scanner in edentulous cases, the results are dependent on the protocol that has been followed. The accuracy of measurements on CBCT scans is software dependent. CONCLUSIONS: Because the precision intraoral scans and of measurements on CBCT scans and is not high enough to allow for the required accuracy, s-CAIS should be considered as an additional tool for comprehensive diagnosis, treatment planning, and surgical procedures. Flapless s-CAIS can lead to implant placement outside of the zone of keratinized mucosa and thus must be executed with utmost care.

Pathogen recognition receptors (PRRs) are a class of germ line-encoded receptors that recognize pathogen-associated molecular patterns (PAMPs). The activation of PRRs is crucial for the initiation of innate immunity, which plays a key role in first-line defense until more specific adaptive immunity is developed. PRRs differ in the signaling cascades and host responses activated by their engagement and in their tissue distribution. Currently identified PRR families are the Toll-like receptors (TLRs), the C-type lectin receptors (CLRs), the nucleotide-binding oligomerization domain-like receptors (NLRs), the retinoic acid-inducible gene-I-like receptors (RLRs), and the AIM2-like receptor (ALR). The environment of the dental pulp is substantially different from that of other tissues of the body. Dental pulp resides in a low compliance root canal system that limits the expansion of pulpal tissues during inflammatory processes. An understanding of the PRRs in dental pulp is important for immunomodulation and hence for developing therapeutic targets in the field of endodontics. Here we comprehensively review recent finding on the PRRs and the mechanisms by which innate immunity is activated. We focus on the PRRs expressed on dental pulp and periapical tissues and their role in dental pulp inflammation.

BACKGROUND: In patients with coronary artery disease who are being evaluated for percutaneous coronary intervention (PCI), procedures can be guided by fractional flow reserve (FFR) or intravascular ultrasonography (IVUS) for decision making regarding revascularization and stent implantation. However, the differences in clinical outcomes when only one method is used for both purposes are unclear. METHODS: with a plaque burden of more than 70%. The primary outcome was a composite of death, myocardial infarction, or revascularization at 24 months after randomization. We tested the noninferiority of the FFR group as compared with the IVUS group (noninferiority margin, 2.5 percentage points). RESULTS: The frequency of PCI was 44.4% among patients in the FFR group and 65.3% among those in the IVUS group. At 24 months, a primary-outcome event had occurred in 8.1% of the patients in the FFR group and in 8.5% of those in the IVUS group (absolute difference, -0.4 percentage points; upper boundary of the one-sided 97.5% confidence interval, 2.2 percentage points; P = 0.01 for noninferiority). Patient-reported outcomes as reported on the Seattle Angina Questionnaire were similar in the two groups. CONCLUSIONS: In patients with intermediate stenosis who were being evaluated for PCI, FFR guidance was noninferior to IVUS guidance with respect to the composite primary outcome of death, myocardial infarction, or revascularization at 24 months. (Funded by Boston Scientific; FLAVOUR ClinicalTrials.gov number, NCT02673424.).

The human oral microbiome refers to an ecological community of symbiotic and pathogenic microorganisms found in the oral cavity. The oral cavity is an environment that provides various biological niches, such as the teeth, tongue, and oral mucosa. The oral cavity is the gateway between the external environment and the human body, maintaining oral homeostasis, protecting the mouth, and preventing disease. On the flip side, the oral microbiome also plays an important role in the triggering, development, and progression of oral and systemic diseases. In recent years, disease diagnosis through the analysis of the human oral microbiome has been realized with the recent development of innovative detection technology and is overwhelmingly promising compared to the previous era. It has been found that patients with oral and systemic diseases have variations in their oral microbiome compared to normal subjects. This narrative review provides insight into the pathophysiological role that the oral microbiome plays in influencing oral and systemic diseases and furthers the knowledge related to the oral microbiome produced over the past 30 years. A wide range of updates were provided with the latest knowledge of the oral microbiome to help researchers and clinicians in both academic and clinical aspects. The microbial community information can be utilized in non-invasive diagnosis and can help to develop a new paradigm in precision medicine, which will benefit human health in the era of post-metagenomics.

BACKGROUND: To reveal the recent epidemiologic features of Kawasaki disease (KD) in South Korea based on data from a nationwide survey. METHODS: We collected data between 2012 and 2014 regarding the incidence, symptoms and signs, treatment trends and coronary complications associated with acute KD by sending questionnaires to 97 hospitals with pediatric residency programs as well as 19 community hospitals without residency training. RESULTS: We received full and partial data from 97 and 13 hospitals, respectively (response rate: 94.8%). A total of 14,916 cases of KD were reported by these 110 hospitals (4588 in 2012, 5183 in 2013 and 5145 in 2014). The male-to-female ratio was 1.4:1, and the median age at diagnosis was 29 months. The incidence of KD per 100,000 children younger than 5 years of age were 170.9, 194.9 and 194.7 in 2012, 2013 and 2014, respectively. The recurrence rate was 4.7%. KD occurred more frequently during summer (especially June and July) and winter (December and January) seasons. Intravenous immunoglobulin was administered to 95.4% of the patients, and the nonresponder rate for the first intravenous immunoglobulin was 11.8%. Coronary aneurysm occurred in 1.7% of the patients, and giant aneurysm developed in 19 patients (0.16%) during the 3 years. One patient had myocardial infarction and 1 patient died of suspected coronary aneurysm rupture. CONCLUSIONS: The incidence of KD in South Korea increased to 194.7 per 100,000 children younger than 5 years in 2014; meanwhile, the coronary aneurysm rate decreased to 1.7%.

To overcome the limitations of the conventional vacuum thermoforming manufacturing method, direct 3D printing of clear aligners has been developed. The present study investigated the thermo-mechanical and viscoelastic properties of a photocurable resin TC-85, which is a new material for the direct 3D printed clear aligners, comparing to a conventional thermoplastic material polyethylene terephthalate glycol. Dynamic mechanical analysis was performed to analyse the mechanical behaviours of the two materials at 37 °C and 80 °C, respectively. Furthermore, the shape memory property of the two materials was evaluated using a U-shape bending test, and the shape recovery ratio for 60 min at 37 °C was calculated. The results indicate that TC-85 can constantly apply a light force to the teeth when used for the 3D printed clear aligners, owing to its flexibility and viscoelastic properties. In addition, it is expected that the force decay induced by repeated insertion of the clear aligners will be reduced and a constant orthodontic force will be maintained. Furthermore, its geometric stability at high temperatures and the shape memory properties provide advantages for the clinical application.

PURPOSE: The purpose of this study was to define the subscapularis tendon footprint anatomy in 3-dimensional (3D) perspective, report the incidence of tears, and classify the tear patterns prospectively during shoulder arthroscopic surgery. METHODS: The cadaveric study consisted of a pilot study that revealed 4 different bony facets by simple observation at the subscapularis attachment. The 3D footprint anatomy was digitally evaluated in 39 cadavers. The clinical study was conducted from 2011 to 2013 and was based on 3D footprint anatomy. All consecutive arthroscopic shoulder operations were prospectively evaluated for subscapularis tendon integrity. A new classification system was developed with 5 categories: (1) type I-fraying or longitudinal split of the subscapularis tendon leading edge; (2) type IIA-less than 50% subscapularis tendon detachment of the first facet; (3) type IIB-greater than 50% detachment without complete disruption of the lateral hood, which is approximately a one-quarter to one-third tear of the entire subscapularis tendon's superior-inferior length; (5) type III-entire first facet with complete-thickness tear (lateral hood tear), (5) type IV-first and second facets are exposed with much medial retraction of the tendon (approximately a two-thirds tear of the entire footprint; entire tendinous portion), and (6) type V-complete subscapularis tendon involving the muscular portion (rare). RESULTS: The medial-lateral and superior-inferior dimensions of the first facet dimensions were 13.8 × 13.5 mm, respectively; its surface area was 34% of the entire footprint. From superior to inferior, the facet's medial-lateral dimensions and surface area decreased. The fourth facet was 77 mm(2) from medial to lateral and encompassed 15% of the footprint. Clinically, among 821 shoulder arthroscopies performed over a 29-month-period, the incidence of subscapularis tears was 415 (50.5%). The most common tear was type IIB (29.4%) or a one-quarter to one-third tear of the entire subscapularis footprint length. However, the incidence between types I, IIA, and IIB did not show a statistically significant difference, indicating an equal distribution. The mean ages of the torn group versus the intact subscapularis group showed a difference. CONCLUSIONS: The first facet of the subscapularis tendon footprint consists of approximately one third of the entire footprint, and the first 2 facets consist of 60% of the entire footprint. The probability of finding any extension of the subscapularis tendon tear occurs in approximately 50% of the patients who undergo shoulder arthroscopy for all forms of shoulder disease. Among those subscapularis tendon tears, less than or equal to 80% are first facet tears. LEVEL OF EVIDENCE: Level II, diagnostic study.

Gold nanoparticles (GNPs) have been previously reported to inhibit osteoclast (OC) formation. However, previous research only confirmed the osteoclastogenesis inhibitory effect under in vitro conditions. The aim of this study was to develop a therapeutic agent for osteoporosis based on the utilization of GNPs and confirm their effect both in vitro and in vivo. We prepared β-cyclodextrin (CD) conjugated GNPs (CGNPs), which can form inclusion complexes with curcumin (CUR-CGNPs), and used these to investigate their inhibitory effects on receptor activator of nuclear factor-κb ligand (RANKL)-induced osteoclastogenesis in bone marrow-derived macrophages (BMMs). The CUR-CGNPs significantly inhibited the formation of tartrate-resistant acid phosphatase (TRAP)-positive multinuclear cells in BMMs without inducing cytotoxicity. The mRNA expressions of genetic markers of OC differentiation including c-Fos, nuclear factor of activated T cells 1 (NFATc1), TRAP, and osteoclast associated receptor (OSCAR) were significantly decreased in the presence of CUR-CGNPs. In addition, the CUR-CGNPs inhibited OC differentiation of BMMs through suppression of the RANKL-induced signaling pathway. Additionally, CUR-CGNPs caused a decrease in RANKL-induced actin ring formation, which is an essential morphological characteristic of OC formation allowing them to carry out bone resorption activity. Furthermore, the in vivo results of an ovariectomy (OVX)-induced osteoporosis model showed that CUR-CGNPs significantly improved bone density and prevented bone loss. Therefore, CUR-CGNPs may prove to be useful as therapeutic agents for preventing and treating osteoporosis.

Background Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge. Objectives To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0·01%, hydroquinone (HQ) 4%, tretinoin 0·05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients. Methods This was a multicentre, randomized, controlled, investigator-blinded, parallel comparison study. East and South-East Asian patients aged 18 years or older, with a clinical diagnosis of moderate to severe melasma, were enrolled in this study. Patients were enrolled at baseline and treated daily for 8 weeks with TC cream (one application at bedtime) or HQ cream (twice daily). There were four study visits: at baseline and weeks 2, 4 and 8. The primary efficacy variable was the melasma global severity score (GSS). Other outcome measures included Melasma Area and Severity Index, global improvement and patient satisfaction. Safety was assessed through the reporting of adverse events. Results TC had superior efficacy to HQ for the primary variable: 77/120 patients (64·2%) on TC had GSS ‘none’ or ‘mild’ at week 8 vs. 48/122 patients (39·4%) on HQ (P < 0·001). The secondary efficacy variables confirmed these results. Patient satisfaction was in favour of TC (90/127, 70·8%, vs. 64/129, 49·6%; P = 0·005). More patients had related adverse events on TC (63/129, 48·8%) than on HQ (18/131, 13·7%) but most were mild and none was severe. Conclusions Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.