Search

Background: Effects of upper facial aging can present as static forehead and periorbital rhytids as well as soft tissue volume loss. The latter can prompt in conjunct with bony changes of the calvaria eyebrow and eyelid ptosis. Injection-based treatments can yield positive outcomes but are not free of procedural risks., Objectives: To assess the clinical outcome of synchronized radiofrequency (RF) and high intensity facial electric stimulation (HIFES) when targeting the upper face with special focus on the effects of musculature, subcutaneous fatty layer, and eyebrow position., Methods: This non-randomized, prospective study included 37 subjects with a mean age of 45.46 years and a mean BMI of 21.84 kg/m2. Subjects received four synchronized RF and HIFES treatments spaced seven days apart. Efficacy measurements were taken at 4-, 16-, and 24-weeks post-treatment using three-dimensional surface imaging, surface electromyography (EMG), and high-resolution facial ultrasound., Results: Forehead and lateral canthal line severity improved statistically significantly at each follow-up visit when compared to baseline with all p<0.001. At week 24, the position of medial/central/lateral eyebrows increased by 3.18/3.02/2.27 mm when compared to baseline with p < 0.001, respectively. At week 24, no statistically significant changes were observed in the thickness of frontalis muscle or of the overlying fatty layer., Conclusions: The application of synchronized RF and HIFES to the frontal region reduced frontal and lateral canthal rhytids and elevated the position of the eyebrow until week 24 after the initial treatment. Based on the results obtained, this non-invasive energy-based treatment option could be a viable alternative to injectable treatments of the upper face when trying to ameliorate the signs of upper facial aging., (© The Author(s) 2025. Published by Oxford University Press on behalf of The Aesthetic Society.)

Objective: NCTF135HA, a versatile polyrevitalizing solution, is a potent agent for enhancing skin quality, radiance, moisture, vitality, and diminishing fine wrinkles caused by aging factors. Data demonstrate a divergence in its application from skin quality enhancement to treatment of vitiligo lesions. To know more precisely about the protocol of use among providers, alone or in combination with other procedures, we performed an international survey., Method: A Steering Committee of dermatologists, aesthetic surgeons, and physicians developed a 32-question questionnaire based on a literature review. Hosted online from January to March 2024, it targeted healthcare professionals experienced in polyrevitalization. Responses were analyzed anonymously and reported descriptively., Results: Practitioners adopt a balanced approach: half of their patients receiving classic Polyrevitalization (NCTF135HA alone) and the other half undergoing combination therapy (NCTF135HA with another aesthetic procedure). Most administer NCTF135HA across multiple sessions, typically three (39.7%). In combination therapy, 55.5% of practitioners use NCTF135HA for medical purposes, targeting Melasma (53.1%) and Rosacea (45.0%) for instance. Aesthetic use is prevalent, with 94.2% employing NCTF135HA for skin wrinkles (79.9%), and refreshment, rejuvenation, and hydration (73.4%). Combining NCTF135HA with hyaluronic acid (71.2%) and botulinum toxin (49.1%) is common, alongside microneedling (50.2%), peelings (32.4%), and fractional radiofrequency (25.6%)., Limitations and Conclusion: Our survey showed a homogenous distribution of NCTF135HA utilization, indicating a consensus on its application across diverse demographics. This consistency highlights its widespread acknowledgment and efficacy in various aesthetic and clinical settings. Limitations include a large respondent group from Mexico and many respondents with less than 10 years of experience., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Midfacial aging involves skeletal changes, muscle weakening, and fat redistribution, resulting in volume loss, skin sagging, and deepened nasolabial folds. High-Intensity Facial Electrical Stimulation (HIFES) combined with Radiofrequency (RF) is a novel non-invasive method to address these changes by enhancing muscle mass and remodeling subcutaneous tissue., Objectives: To assess the efficacy of HIFES and Synchronized RF in improving midfacial aesthetics, specifically muscle thickness, skin displacement, and facial volume., Methods: This prospective, non-randomized study included 37 participants who underwent four HIFES and RF treatments over 24 weeks. Assessments at baseline, 4, 16, and 24 weeks used ultrasound imaging, electromyography (EMG), 3D surface imaging, and the modified Fitzpatrick Wrinkle Scale (FWS). A related porcine study evaluated the treatment's histological effects., Results: Zygomaticus Major Muscle (ZMM) thickness increased from 2.06 mm to 2.80 mm, with a 39.3% rise in EMG signal strength, indicating improved muscle function. Skin displacement analysis revealed horizontal (0.90 mm) and vertical (1.01 mm) shifts, particularly laterally. Midface volume increased by 1.43 cm³ at 24 weeks. The porcine study confirmed increased muscle fiber size, myonuclei count, and mass density, aligning with human results., Conclusions: HIFES and Synchronized RF treatments significantly improved muscle thickness, skin displacement, and facial volume, effectively rejuvenating the midface. These clinical findings, supported by histological evidence, suggest a promising non-invasive approach for facial rejuvenation. Further randomized studies are needed to confirm these results and assess long-term effects., (© The Author(s) 2025. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Microfocused ultrasound with visualization (MFU-V) is an advanced, non-invasive cosmetic procedure widely used in skin lifting and tightening. We performed a systematic review and meta-analysis to evaluate the aesthetic effectiveness, patients' satisfaction, skin quality, and safety profile of MFU-V treatment. A comprehensive search of 5 bibliographic databases up to 2023 was conducted. Pooled effect estimates using random effects models and corresponding 95% confidence intervals (95% CI) were calculated. Out of 4,019 references, 42 studies were included. Meta-analysis showed 89% of patients (95% CI: 81- 94%; I2: 63%, n=411) demonstrated some degree of global aesthetic improvement, as assessed by investigators. Similarly, 84% of patients (95% CI: 73- 91%; I2: 64%, n=312) reported improvement following treatment. Satisfaction of any level was reported by 84% of patients (95% CI: 61- 94%; I²: 52%, n=326), and 62% (95% CI: 37- 82%; I²: 3%, n=172) when 'neutral' as a response was provided for the patients. Skin quality (e.g., wrinkles, texture) also improved. Patients reported a pooled mean pain score of 4.85 (95% CI: 4.35, 5.35; I2: 97%, n=785), indicating moderate pain. Common adverse events included erythema, edema, swelling, bruising, and tenderness, all of which were generally mild to moderate in severity. Overall, our analysis demonstrated a notable increase in global aesthetic improvement and patients' satisfaction following MFU-V treatment, accompanied by moderate pain and a generally favorable safety profile. However, the potential misclassification of neutral responses as positive could result in an overestimation of the treatment's efficacy. These findings highlight the need for well-designed trials to further explore MFU-V's clinical applications., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: Microfocused ultrasound with visualization (MFU-V) is widely used in aesthetic medicine for skin tightening and rejuvenation. However, its role in regenerative aesthetics and its precise mechanism of action are not fully understood., Objective: This narrative review aims to contextualize and articulate the mechanism of action of MFU-V, evaluate its role in regenerative aesthetics, and assess its effectiveness based on existing clinical, histological, and skin-mechanical studies., Methods: A comprehensive literature search was performed to collect and analyze studies on MFU's biological mechanisms, clinical outcomes, and impact on extracellular matrix (ECM) regeneration. The review integrates findings from clinical trials, histological analyses, and biomechanical assessments to provide a cohesive understanding of MFU-V's role in aesthetic medicine., Results: MFU-V emits focused ultrasound energy that penetrates multiple skin layers and the superficial musculoaponeurotic system, creating localized thermal coagulation points. These points initiate biological responses that recruit fibroblasts and stimulate the production of new collagen and elastin fibers. Enhanced ECM protein synthesis leads to significant improvements in skin biomechanics and quality, reducing skin laxity and enhancing appearance. Clinical studies support these findings, showing improvements in skin firmness and texture following MFU-V treatment., Conclusion: Through analyzing the underlying biological mechanisms and the observable clinical outcomes, this narrative review sets the stage for a comprehensive understanding of the mechanism of action and role of MFU-V in regenerative aesthetics., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Surgical, minimally-invasive, and non-invasive aesthetic procedures try to ameliorate the signs of facial aging, but also focus on enhancing various individual features of beauty in each patient. Herein, the midface plays a central role due to its location but also its importance for the aesthetic perception and facial expression., Objective: To date, no study has investigated the interplay between facial muscles and its connecting subdermal architecture during facial aging to provide a more comprehensive understanding of the middle face., Materials and Methods: A total of 76 subjects, consisting of 30 males (39.5%) and 46 females (60.5%) with a mean age of 42.2 (18.7) years [range 19-80] and a mean BMI of 24.6 (3.7) kg/m 2 [range 18-35], were enrolled in this investigation. Cutometry (skin aging), 3D skin displacement analyses (subdermal connective tissue aging), and sEMG (muscle aging) analyses were utilized., Results: The results revealed that overall skin firmness increased, and skin elasticity decreased (p < 0.001), sEMG signal of the investigated muscles decreased (p < 0.001), whereas midfacial mobility remained unaltered (p = 0.722)., Conclusion: The results of this study indicate that midfacial aging is a measurable effect when utilizing individual measurement modalities for assessing skin, subdermal fascia, and midfacial muscles. The function of midfacial muscles revealed a potential threshold effect, which is not reached during midfacial aging due to the unchanged soft tissue mobility at older age. However, to understand its clinical presentation all midfacial soft tissues need to be factored in and a holistic picture needs to be created., No Level Assigned: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes review articles, book reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to authors www.springer.com/00266 ., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

The use of hyaluronic acid-based soft tissue fillers has often been reported to modulate the muscle, that is, to cause myomodulation. To our knowledge, there has been so far no scientific study investigating the potential of hyaluronic acid-based soft tissue fillers to modulate or actually alter the function of facial muscles. To further assess this three-dimensional (3D) surface imaging and electromyography (EMG)-based prospective study investigated the changes of facial muscle contraction after injection of strategically placed hyaluronic acid-based soft tissue fillers to assess the actual validity of the term myomodulation. A total of 13 subjects with a mean age of 37.8 years (12 females, 1 male) were injected according to a predefined injection protocol. Surface EMG and 3D surface imaging were performed prior to the injection and 5 days after the injection. The results showed no significant change in the strength of the muscles (measured in μV) after injection of hyaluronic acid-based soft tissue fillers. However, horizontal and vertical skin displacement upon contraction of the zygomaticus major muscle changed significantly between baseline and follow-up, with a mean horizontal skin displacement increase from 3.2 to 4.1 mm. Upon contraction of the depressor anguli oris muscle, the horizontal skin displacement did not change significantly (2.15 vs. 2.05 mm), while vertical skin displacement increased significantly from 2.9 to 4.3 mm. The modification of the surrounding tissue caused an alteration of the vectorial skin displacement upon contraction of the muscle. A potential explanation could be the increased distance between the origin and insertion of the muscle due to the material deposition in the proximity of the relevant facial muscles, leading to a change of contraction vector., Competing Interests: None declared., (Thieme. All rights reserved.)

Introduction: Varicella (chickenpox) is an infectious disease caused by the varicella zoster virus affecting children, adolescents, and adults. Varicella symptoms are usually self-limiting; however, different complications with widespread and systemic manifestations can occur. This systematic literature review aims to explore and quantify varicella-associated complication rates., Methods: Two databases (Embase and MEDLINE), congress abstracts, and reference lists of systematic reviews were screened to identify evidence on varicella complications. Complications were identified and grouped into 14 clinically relevant categories. Proportional meta-analyses were conducted using a random-effects model and tests for heterogeneity and publication bias were performed. Subgroup, sensitivity, and meta-regression analyses were also conducted. A total of 78 studies, spanning 30 countries, were included in the meta-analysis., Results: Pooled prevalence was highest in severe varicella (22.42%; 95% confidence interval [CI] 10.13-37.77), skin-related complications (20.12%; 95% CI 15.48-25.20), and infection-related complications (10.03%; 95% CI 7.47-12.90). Cardiovascular (0.55%; 95% CI 0.08-1.33), genitourinary (1.17%; 95% CI 0.55-1.99), and musculoskeletal (1.54%; 95% CI 1.06-2.11) complications had the lowest pooled prevalence. The remaining complication categories ranged between 1% and 10%. Subgroup analysis showed that complications were more prevalent in children versus adults and in hospitalized patients versus outpatients. Meta-regression analysis found that no ecological level covariates were accurate predictors for the overall prevalence of varicella-associated complications. There was substantial heterogeneity and publication bias across all meta-analyses., Conclusion: Results suggest that different types of varicella-associated complications could be frequent, impacting quality of life, and healthcare resource utilisation and budgets. These findings are crucial to raise awareness of the health and economic burden of varicella disease., (© 2023. GSK.)

Combined measles-mumps-rubella (MMR) vaccines produced by GSK (GSK-MMR) and Merck (Merck-MMR) have demonstrated effectiveness and an acceptable safety profile, as documented over decades of post-licensure use in various regions worldwide. In the United States, 2 doses of the MMR vaccine are recommended at the ages of 12-15 months and 4-6 years. All-cause febrile convulsions have the highest incidence at 12-18 months of age, when the first MMR vaccine dose is administered. Because febrile convulsions can also occur rarely after MMR vaccine administration, we reviewed safety data of the GSK-MMR compared to the Merck-MMR vaccine from 4 clinical trials that evaluated a first dose in 12-15-month-olds and 2 clinical trials that evaluated a second dose in ≥4-year-olds. Overall frequencies of febrile convulsions were ≤0.4% across studies and vaccine groups. The frequency of febrile convulsions occurring 7-10 days post-vaccination with the GSK-MMR vaccine (5.7/10,000) was generally consistent with previously published data. The other safety outcomes were similar between the GSK-MMR and Merck-MMR vaccines in both age groups. Hence, as recommended by the Advisory Committee on Immunization Practices, the GSK-MMR vaccine can also be used for routine immunization of children according to the current immunization schedule in the United States to prevent MMR.

Objective: With more than 1.5 million performed procedures, liposuction was the second most performed esthetic surgical procedure all over the world in males and in females in the year 2020. The objective of this open-label, evaluator-blinded study was to assess the efficacy and safety of an energy-based device that combines multipolar radiofrequency with pulsed electromagnetic field (PEMF) in patients that underwent liposuction., Materials and Methods: A total of 30 subjects, of whom 24 were females (80%), with a mean age of 48.4 ± 11.0 years (range: 27-69 years) and a mean weight of 69.5 ± 11.7 kg underwent unilateral treatment with radiofrequency and application of PEMF after bilateral liposuction. One month after the last of a total of six weekly treatments, skin elasticity, visco-elasticity and net elasticity, as well as subject reported satisfaction on a 5-point scale ranging from -1 (worse) to 3 (very much improved) and esthetic improvement ranging from 0 (very unsatisfied) to 4 (very satisfied) rated by three independent reviewers were assessed., Results: Three independent and blinded reviewers rated the improvement of the treated side on average as 1.17 + 0.07 compared with baseline. Subjects were very satisfied with their treatment, with a mean score of 3.24 (0.03) out of 4 at the 1-month follow-up visit. Cutometer measurements showed no significant changes., Conclusion: This study revealed that the subjective satisfaction with the results of the application of RF and PEMF after liposuction is high, while at the same time the esthetic appearance as rated by independent raters improved on the treated side., (© 2023 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Neuromodulators have predominantly been used for the treatment of upper facial lines, but their use has expanded to include lower face and neck treatments. However, the injection sites for these treatments are based on skin surface landmarks, which may pose risks to nearby structures and result in undesired outcomes., Objective: To investigate the spatial relationship between the FDA-approved skin surface landmarks for neuromodulator injections in the parotid and submandibular glands and the topographical anatomy of critical facial structures such as the facial artery, facial vein, external carotid artery, and retromandibular vein., Materials and Methods: A cross-sectional retrospective analysis was conducted on contrast-enhanced cranial CT scans. The scans were analyzed for the morphology and location of the parotid and submandibular glands. Measurements were taken for gland volume, craniocaudal extent, anterior-posterior extent, and distances between the skin surface and gland capsule or nearby structures such as arteries., Results: The study sample consisted of 53 subjects, including 7 males and 46 females, with a mean age of 36.91 years and a mean BMI of 23.28 kg/m 2 . The mean volume of the parotid gland was 31.9 ± 3.0 cc in males and 28.5 ± 3.6 cc in females with p < 0.001, while the mean volume of the submandibular gland was 18.2 ± 2.0 cc in males and 14.5 ± 3.4 cc in females with p < 0.001. The mean distances between skin surface and the gland capsule were 5.98 ± 2.2 and 8.84 ± 4.0 mm for the parotid and submandibular gland, respectively. This distance increased with higher age and higher BMI values in a statistically significant manner with p < 0.001., Conclusion: The distances between FDA-approved skin surface landmarks and the parotid and submandibular glands varied significantly depending on gender, age, and BMI. Optimal injection depth and location for neuromodulator treatments cannot be generalized based on these landmarks alone, emphasizing the need for real-time ultrasound imaging guidance., (© 2023 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: The European esthetic experience is informative for understanding both innovation as well as how to care for patients of various backgrounds and ages., Aims: To discuss best practices for treating the European population and how these approaches may be applied to patient populations across the globe., Patients/methods: In support of clinicians who wish to serve a diverse patient population, a 6-part, international roundtable series focused on diversity in esthetics was conducted from August 24, 2021 to May 16, 2022. In each roundtable, expert clinicians were invited to contribute and share best practices., Results: The results of the fifth roundtable in the series, the European Patient, are described here. Key ideas include the growing number of people over the age of 65 years in Europe and the management of this more mature patient population; the role of functional anatomy in treating patients with both fillers and botulinum toxin; and the role of ultrasound in clinical practice for mapping vasculature., Conclusions: While there is no typical European face, there is much to be learned from thoughtful consideration of how to best manage more mature patients as well as how to use minimally invasive modalities, such as injectables, efficiently to achieve natural-looking results., (© 2023 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: An increasing demand for in-office aesthetic procedures aiming to improve collagen stimulation has been reported., Objective: To analyze the effects of combinations of different aesthetic collagen stimulation procedures using histological analysis., Methods: Histological analysis was performed on skin samples of the excess skin of a 60-year-old patient after sub-superficial musculo-aponeurotic system facelift surgery. The excess skin before facelift surgery was divided into three areas per hemiface. Each area-with exception of area A as a control-received an isolated or combined treatment of microfocused ultrasound (MFU), injections of calcium-hydroxylapatite/hyaluronic-acid-based soft tissue filler, and microneedling. The effect of the treatments was analyzed using histological analysis with H&E coloration and PAS staining., Results: A threefold increase of epidermal and dermal thickness was achieved by treating the skin with the proposed combined treatment comprising MFU and injections of calcium-hydroxylapatite- and hyaluronic-acid-based soft tissue fillers., Conclusion: The investigated treatments act synergistically in the production of collagen and combining these treatments allows for an increase in collagen production., (© 2023 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Increasing demand for minimally invasive aesthetic treatments, such as injection of biostimulator substances to induce the production of extracellular matrix, has been reported. Recent studies have reported on a variety of different product characteristics influencing the integration and distribution of biostimulator substances after injection., Objectives: The aim of this study was to analyze the ex vivo product integration and distribution behavior of 6 different biostimulator substances after injection., Methods: A total of n = 21 abdominal soft tissue flaps were analysed by real-time ultrasound imaging with regards to horizontal and vertical spread of 6 different injected biostimulator substances-based on hydroxylapatite (HA), polycaprolactone (PCL), and poly-L-lactic acid (PLLA)-immediately after injection and after massaging. The 6 different biostimulator substances were R-CaHA-based, H-CaHA-based, PCL-based, PLLA-1-based, PLLA-2-based and H-HA-based products., Results: Overall, the R-CaHA-, H-CaHA-, and PCL-based substances showed greater product spread after massaging when compared with the product distribution immediately after the injection with all P < .001 with the exception of the vertical dimension of the H-CaHA-based substance (P = .064). The PLLA-1-, PLLA-2-, and H-HA-based substances showed smaller product spread after massaging compared with the product distribution immediately after the injection with all P < .001 with the exception of the horizontal dimension of the H-HA-based substance (P = .314), indicating higher tissue integration., Conclusions: Different biostimulator substances behave differently when injected into subcutaneous soft tissues; differences exist at the level of initial product diffusion and during tissue integration., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Calcium hydroxylapatite (CaHA; Radiesse, Merz North America) restores volume and stimulates collagen production. The aim of this research was to explore the role of dilution and diffusion in microsphere distribution and the effect of CaHA concentration on activation of fibroblasts to produce collagen., Methods: Ex vivo: Tissue dispersion of CaHA was assessed in abdominal tissue segments obtained from patients which were subsequently injected with CaHA diluted to 1:1 and hyperdiluted to 1:2. In vitro: Collagen type III (COLIII) and type I (COLI) expression of fibroblasts was evaluated after 24 and 72 h of incubation with CaHA concentrations of 1.5 (high dilution), 3.0, and 4.5 mg/ml (low dilution)., Results: Ex vivo: The 1:2 CaHA hyperdilution increased dispersion and decreased concentration of CaHA microspheres compared with the 1:1 dilution. In vitro: CaHA incubation resulted in an increased mean COLIII expression of 123% at 24 h. COLI synthesis did not change after 24 h but increased up to 124% at 72 h. Only fibroblasts in direct contact with CaHA increased COLIII expression. COLIII high-expressing cells were fully activated by CaHA and resulted in the same level of COLIII expression per cell independent of the CaHA dilution., Conclusions: A 1:2 hyperdilution of CaHA increased tissue dispersion of CaHA microspheres. Direct contact of CaHA with fibroblasts was a key factor for inducing neocollagenesis. COLIII high-expressing cells were fully activated by CaHA and resulted in the same expression level of COLIII per cell independent of the CaHA amount in each dilution. This indicates that increased collagen expression was due to the activation of more fibroblasts., (© 2022 Merz Aesthetics GmbH. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Introduction: Studies on quadrivalent measles, mumps, rubella, and varicella (MMRV) vaccines have indicated a twofold increased relative risk of febrile convulsion (FC) after the first dose compared to MMR and V administered at the same medical visit (MMR+V)., Areas Covered: This narrative review contextualizes FC occurrence after the first MMRV vaccine dose from a clinical perspective and outlines approaches to attenuate FC occurrence post-vaccination., Expert Opinion: While the relative FC risk increases after the first dose of MMRV compared to MMR+V vaccine in measles-naïve infants, the attributable risk is low versus the overall FC risk in the pediatric population triggered by other causes, like natural exposure to pathogens or routine vaccination. No increased risk of FC has been reported after MMRV co-administration with other routine vaccines compared to MMRV alone. Based on our findings and considering the MMRV vaccination benefits (fewer injections, higher coverage, better vaccination compliance), the overall benefit-risk profile of MMRV vaccine is considered to remain positive. Potential occurrence of FC in predisposed children (e.g. with personal/family history of FC) may be attenuated if they receive MMR+V instead of MMRV as the first dose. It is also important to monitor vaccinees for fever during the first 2 weeks post-vaccination.

Aim: Several countries, such as Norway and Sweden, have not implemented universal varicella vaccination. We present data for Norway and Sweden that were generated by a paediatric multi-country Phase III study over a 10-year period. This assessed the efficacy, antibody persistence and safety of two varicella vaccines containing the same Oka strain., Methods: This was an observer-blind, controlled trial conducted in 10 European countries. Children aged 12-22 months (n = 5803) were randomised 3:3:1 and vaccinated between 1 September 2005 and 10 May 2006. The two-dose group received two tetravalent measles-mumps-rubella-varicella vaccine doses. The one-dose group received one monovalent varicella vaccine dose after a measles-mumps-rubella vaccine dose. Control group participants received two measles-mumps-rubella vaccine doses. Main study outcomes were vaccine efficacy against confirmed varicella cases and incidence of adverse events., Results: Vaccine efficacy in the two-dose group was ≥92.1% in both Norwegian and Swedish children compared to 72.3% in Norway and 58.0% in Sweden in the one-dose group. Incidences of adverse events and serious adverse events were similar in the Norwegian and Swedish study populations., Conclusion: Consistent with overall study results, high efficacy against varicella and acceptable safety profiles of the two varicella vaccines were observed in Norwegian and Swedish populations. These findings highlight the benefits of varicella vaccines, particularly when administered as a two-dose schedule., (© 2021 GlaxoSmithKline Biologicals S.A. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.)