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Background Prader-Willi syndrome (PWS) is a rare complex genetic disorder and is characterized by short stature, muscular hypotonia, abnormal body composition, psychomotor retardation, and hyperphagia. Recombinant human growth hormone (rhGH) treatment improves the symptoms in children with PWS, and early treatment results in more favorable outcomes. However, systematic studies in infants and toddlers under 2 years of age are lacking. This multicenter, randomized, active-controlled, parallel-group, open-label, Phase III study aimed to evaluate the safety of rhGH (Eutropin, LG Chem, Ltd.) and its efficacy on growth, body composition, and motor and cognitive development in infants and toddlers with PWS compared with a comparator treatment (Genotropin, Pfizer, Inc.). Eligible Korean infants or toddlers with PWS were randomly assigned to receive Eutropin or comparator (both 0.24 mg/kg/week, 6 times/week) for 1 year. Height standard deviation score (SDS), body composition, and motor and cognitive development were measured. Results Thirty-four subjects (less than 24 months old) were randomized into either the Eutropin (N = 17) group or the comparator (N = 17) group. After 52 weeks of rhGH treatment, height SDS and lean body mass increased significantly from baseline in both groups: the mean height SDS change (SD) was 0.75 (0.59) in the Eutropin group and 0.95 (0.66) in the comparator group, and the mean lean body mass change (SD) was 2377.79 (536.25) g in the Eutropin group and 2607.10 (641.36) g in the comparator group. In addition, percent body fat decreased significantly: the mean (SD) change from baseline was − 8.12% (9.86%) in the Eutropin group and − 7.48% (10.26%) in the comparator group. Motor and cognitive developments were also improved in both groups after the 1-year treatment. The incidence of adverse events was similar between the groups. Conclusions rhGH treatment for 52 weeks in infants and toddlers with PWS improved growth, body composition, and motor and cognitive development, and efficacy and safety outcomes of Eutropin were comparable to those of Genotropin. Hence, Eutropin is expected to provide safe and clinically meaningful improvements in pediatric patients with PWS. Trial registration The study was registered at ClinicalTrials.gov (identifier: NCT02204163) on July 30, 2014. URL: https://clinicaltrials.gov/ct2/show/NCT02204163?term=NCT02204163&rank=1

Supplemental Digital Content is available in the text., Background: Hyaluronic acid (HA) fillers for volume augmentation in the anteromedial malar region of Asians have been popular for many years. However, studies on their long-term effectiveness are lacking. This study aimed to evaluate the effectiveness and safety of HA fillers injected into the anteromedial malar region for volume augmentation for up to 52 weeks. Methods: Each anteromedial malar region of the subjects was treated with YVOIRE Contour (YVOC) in one side and Restylane Sub-Q (RESS) in the other and followed up at weeks 2, 14, 26, and 52. The volume using the mid-face aesthetic scale (MFAS) ranging from 0 (full) to 4 (very severely sunken) and the subject’s satisfaction and adverse events were evaluated. Results: Total 83 subjects were randomized and treated with YVOC and RESS. The LS means (standard error) of MFAS score in the YVOC and RESS groups were both 2.56 (0.05) at baseline, 1.32 (0.07) and 1.39 (0.07) at week 26, and 1.84 (0.10) and 1.89 (0.10) at week 52, respectively. The difference in the LS mean of MFAS score between the groups at week 26 was 0.07 (95% confidence interval, 0.01–0.12), showing the non-inferiority of YVOC to RESS. About 70% of subjects were still satisfied with the results at week 52. No specific safety concern was detected. Conclusions: The HA fillers injected for the anteromedial malar augmentation maintained the volume well for up to 52 weeks. Additionally, both YVOC and RESS show similar effectiveness and safety profiles.