New research has found that a drug used to treat high blood pressure could help women with persistent acne. SAFA is the first large-scale clinical trial to show that spironolactone is an effective treatment for the skin condition. The results, published in the British Medical Journal, could inform routine acne treatment. This would help reduce the amount of antibiotics prescribed for the condition. Professor Miriam Santer from the University of Southampton co-led the trial. It was run by the Southampton Clinical Trials Unit (CTU). The research was aligned with the NIHR Southampton Biomedical Research Centre’s Microbiology, Immunology and Infection theme. A need for new treatments Acne is very common, particularly in adolescence, and often clears with age. But almost a third of women are still affected in adulthood. This can be a huge physical and psychological burden to those who suffer from persistent outbreaks. Topical treatments (creams and gels), available from a pharmacy or on prescription, are the first-line treatment for acne. They are effective for many people. If they don’t work, GPs will often prescribe oral antibiotics to be used alongside the creams and gels. This can add to the growing burden of antibiotic resistance in the population. “For several years, dermatologists have been prescribing a drug called spironolactone to treat severe acne,” says Professor Alison Layton, consultant dermatologist and co-lead of the SAFA trial. “This is a cheap medication which has been used for decades in the treatment of high blood pressure. The drug also reduces the main hormone that leads to the development of acne. “However, previous studies of spironolactone for acne have been very small and there was no definitive proof that it actually worked.” An effective treatment The SAFA trial recruited over 400 women aged 18+. They all had persistent acne, and oral antibiotics would have been their next treatment. Half were randomly allocated to take spironolactone. The other half were given a placebo pill. The women completed questionnaires on their acne and quality of life at the start of the trial. They did this again when they were 12 and 24 weeks into the treatment. “The women taking spironolactone saw a significant improvement in their acne after 12 and 24 weeks compared to those on the placebo,” says Professor Santer, GP and co-lead of the trial. “A significantly higher proportion of people said they felt satisfied that the treatment had helped their skin. Any side effects were uncommon and very minor. “These results show that spironolactone could offer an alternative to antibiotics for many women with persistent acne to use alongside topical acne treatments.” Making a difference Kelly Cornick, 39, began suffering with severe acne in her teens. Since then, she has been prescribed various creams, antibiotics and the contraceptive pill to try and control her skin. “Nothing seemed to work,” says Kelly. “It might go away for a while, but then it would flare up again. It was sore, almost like blisters. I would get thick, red, lumps all along my jawline and at its worst it spread up onto the rest of my face. If I knocked a spot, it would really hurt and would bleed for ages. It was just horrible.” The mum-of-three from Dorset says it had a huge effect on her physical and psychological health. “It was embarrassing. People would stare and you almost feel that they’re looking at you like you’re dirty and don’t wash properly. “I think the worst thing for me was when one of my nieces asked if I had Chickenpox. She was only about two and kids are always quite honest, but that’s how bad it looked. It used to get me down. I’m a confident person but my skin just took over how I felt a lot of the time.” Kelly heard about the SAFA trial from her dermatologist and contacted the trial team at Poole Hospital. “Initially I started on the lower dose and there was an improvement. I then went onto the higher dose and within about three months everything was gone, all the spots had disappeared.” Since finishing the trial, Kelly has been able to stay on spironolactone and has now been acne-free for over two years. “Knowing how much it’s helped me, I hope that other people will now be given this treatment as an option instead of just trying antibiotics. I want people to be able to experience it, because everyone should feel confident and happy, and not have spots.” Encouraging results Zina Eminton is a Senior Trial Manager at Southampton CTU. She said: “This was a challenging trial which began just as the COVID-19 pandemic hit the UK. This meant we had to adapt to be flexible in the way the trial was run, using social media to help recruit participants and conducting virtual follow-up appointments. The results are a fantastic achievement for everyone involved and will benefit many more women in the future.” Professor Andrew Farmer, Director of NIHR’s Health Technology Assessment Programme, said: “The findings from this important trial provide compelling evidence which could help thousands of women with persistent acne. The treatment provides a valuable alternative to antibiotics. It ensures clinicians can also better avoid the harms that can arise from antimicrobial resistance. “High quality, independently funded research like this is crucial in providing evidence to improve health and social care practice and treatments.” Professor Santer concludes: “We hope the publication of these results will mean more GPs and dermatologists feel confident to prescribe spironolactone as a treatment for acne. The drug is already included in treatment guidelines for persistent acne in the US and Europe. We hope this trial will lead to a change in the UK guidelines.” The SAFA trial was funded by a Health Technology Assessment grant from the National Institute for Health and Care Research. It was sponsored by the University of Southampton.

New results from an international study show a treatment could greatly reduce the number of babies admitted to hospital with a common virus. Respiratory Syncytial Virus (RSV) affects 90% of children before the age of two. It is one of the leading causes of hospitalisation in all infants worldwide. These new results from the HARMONIE study show nirsevimab, a monoclonal antibody immunisation, could help prevent large numbers of babies with an RSV infection needing hospital care. Nirsevimab was approved for use in the NHS in November 2022. This study is exploring if it could stop babies being hospitalised with RSV and help the NHS decide how best to use it. More than 8,000 babies under 12 months old are taking part across France, Germany and the UK, including many families in the Southampton area. The study is being delivered locally by the NIHR Southampton Clinical Research Facility at University Hospital Southampton (UHS) and by local GPS and hospitals across the region. The new results have been reported by BBC News in a visit to UHS. Preventing hospitalisations RSV often causes only mild illnesses, like a cold. However, for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia. Nearly 80% of the children admitted to hospital with RSV are previously healthy. The trial aimed to see if nirsevimab could protect babies entering their first RSV season. Babies who received a single dose of nirsevimab showed an 83 percent reduction in hospital admissions compared to babies who had standard care. Dr Katrina Cathie, UHS consultant paediatrician and Southampton study lead, said: “This is a fantastic result, and I’d like to say a big thank you to all the families who took part across our region. “Through your help, we’ve been able to show nirsevimab can protect babies against serious RSV infections requiring hospital care.” Reducing winter pressures The HARMONIE study is a collaboration between Sanofi and the National Institute for Health and Care Research (NIHR). Thomas Triomphe, Executive Vice President, Vaccines, Sanofi, said: “This winter saw higher rates of RSV-related infant hospitalisations than during pandemic or pre-pandemic years. The HARMONIE data demonstrate the real-world impact nirsevimab has on paediatric hospitalisations, and illustrate its importance for infants, their families and public health.” The results were presented at the 41st Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Dr Simon Drysdale, Consultant Paediatrician in Infectious Diseases at St. George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of HARMONIE, said: “RSV-related chest infections lead to high numbers of infants under 12 months old being hospitalised every year. These data reinforce the potential public health benefit of nirsevimab in terms of helping to reduce the strain on hospitals caused each year by RSV.”

An international study involving Southampton researchers is assessing support for parents that could reduce childhood obesity, starting before pregnancy. The Healthy Life Trajectories Initiative (HeLTI) was developed with the World Health Organization (WHO). It is recruiting 22,000 women in China, India, South Africa and Canada. The programme is assessing care from before pregnancy until children are five years old. Supporting families The project will research support to help mothers eat well, maintain a healthy weight, reduce stress and prevent mental illness. They also aim to investigate parenting skills support, such as how to help babies and children eat, exercise, and sleep well. Prof Shane Norris, Professor of Global Health at the University of Southampton, is leading the South Africa arm of the project. He is a researcher in the NIHR Southampton Biomedical Research Centre’s Nutrition, Lifestyle and Metabolism theme. Dr Kalyanaraman Kumaran, Associate Professor of Epidemiology and Public Health, is leading the India arm of the programme. Women recruited to the study who conceive (an expected 10,000) and their children will be contacted at various stages of life. This will start before pregnancy, continuing through pregnancy, infancy, and early childhood up to the age of five years. Meeting health leaders HeLTI leaders recently met in South Africa to discuss the project’s early findings. They were joined by the South African Minister of Health, Dr Joe Phaahla, the Director General of WHO, Tedros Adhanom Ghebreyesus, and the President of the South African Medical Research Council, Professor Glenda Gray. Discussions focused on how health and care before pregnancy could reduce childhood obesity. They also spoke about how the first 1,000 days are particularly important for mothers’ and children’s health. Prof Norris said: “Being healthy before pregnancy is extremely important for women to have a healthy pregnancy and birth, and for her baby to be healthy. “Supporting women and young children from these very early stages, including during the critical period of the ‘first 1000 days’, helps to give all children the best start in life. “We are very proud to be taking a leading role in such an important international study. The recent meeting was very productive, especially as we had the opportunity to discuss the HeLTI with policymakers.”

Prof Nicholas Harvey has won a prestigious science award for osteoporosis research. He has been honoured with the International Osteoporosis Foundation (IOF) Olof Johnell Science Award. Osteoporosis is a condition that weakens bones, making them fragile and more likely to break. It affects over three million people in the UK. Prof Harvey received the prize at the 2023 IOF-ESCEO World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases in Barcelona, Spain. Recognising excellence Prof Harvey is Professor of Rheumatology and Clinical Epidemiology, and Director of the University of Southampton’s MRC Lifecourse Epidemiology Centre (MRC LEC). He is part of the NIHR Southampton Biomedical Research Centre’s Nutrition, Lifestyle and Metabolism theme. The award recognises individuals who have made outstanding contributions to osteoporosis science or policy worldwide. It is named after the renowned investigator Professor Olof Johnell. His legacy includes major contributions to osteoporosis research, guideline development and healthcare policy. The award is presented at the annual WCO-IOF-ESCEO. This year's event was opened by Professor Cyrus Cooper, previous MRC LEC Director and current IOF President. Professor Harvey commented: “It is an enormous honour to receive this prestigious international award. It is accepted very much on behalf of my friends and colleagues at the MRC Lifecourse Epidemiology Centre. "It was particularly pleasing that the award was presented by Professor Cyrus Cooper, forerunning MRC LEC Director, my long-standing mentor and friend. He is someone who had known and worked closely with Olof Johnell in the genesis of the modern era of osteoporosis fracture risk assessment.” Team effort The WCO-IOF-ESCEO is the world’s largest forum for the presentation of clinical research and new advances in the field. This year’s event was the first face-to-face WCO meeting since 2019. It attracted over 3,000 delegates, with a similar number joining online. The work of Southampton early career researchers was also recognised at the event. Stefania D’Angelo, Dr Lucy Gates and Dr Leo Westbury received IOF-ESCEO Young Investigator awards. Dr Faidra Laskou received an IOF Early Career Nutrition Research Award.

Professor Philip Calder has been honoured with the Stephen S. Chang Award. The international prize recognises his outstanding contribution to Omega-3 research. Omega-3 fatty acids are sometimes known as ‘healthy fats’. They cannot be made by the body and must be introduced as food. Prof Calder is driving new research as Head of the School of Human Development and Health at the University of Southampton. He is also part of the NIHR Southampton Biomedical Research Centre’s Nutrition, Lifestyle and Metabolism theme. Award-winning work The prestigious award is bestowed by the American Oil Chemists’ Society. It is awarded to a person internationally recognised for their contributions in the field of lipid research. Prof Calder’s work focuses on the metabolism and functionality of fatty acids. This includes omega-3 and the influence of diet and nutrients on immune and inflammatory responses. Showcasing findings Recipients have the opportunity to deliver lectures at the prize ceremony. Prof Calder’s lecture was entitled ‘Omega-3 fatty acids and inflammation – relevance to public health and patient outcomes’. It showcased findings from clinical trials and considered the development of pharmaceutical grade omega-3 products. Prof Calder said: “It is a great honour to receive one of the Society’s most prestigious awards. It recognises the excellent work done by people in my group over an extended period and the relevance of this work to public health and patient benefit.”

Southampton teenagers have created a digital guide to support students during the exam period. The guide was co-created by a youth panel from the LifeLab programme. It will help teenagers look after their mental and physical health as they navigate exams. The free and interactive guide is available here. LifeLab is run in partnership between the University of Southampton, the NIHR Southampton Biomedical Research Centre and University Hospital Southampton. “By young people, for young people” Six pupils from local schools and colleges met over the course of a school term to create the digital guide. The panellists pooled their own experiences of exam stress and management with those of their peers. They also received expert advice from LifeLab and the University. The resource covers topics such as healthy eating, sleeping and time management to help students cope with exam pressure and anxiety. Youth Panel member Emily took part to ensure young people feel heard. She explained: "I wanted to make sure that our resource was created by young people, for young people. I'm so pleased that I got to share the voice and opinions of other young people and have the privilege of working with such amazing team members.” Working with schools and colleges LifeLab Youth Panels actively involve young people in creating and delivering solutions that could improve their own health and that of their peers. They are employed by the University and paid for their time. A previous panel co-created a Clinical Research magazine promoting pioneering trials in the city. Esther was proud to be part of the Youth Panel. She said: “I understand how big and scary exams feel and I can't do anything to change that. But it is important that students look after their mind and body to make sure they feel their best when going into them. This resource will guide them in the right direction to do just that.” Dr Clare Merivale, Widening Participation Coordinator at the University, worked with LifeLab and the Youth Panel on the exam resource. She said: “What this Youth Panel has produced is brilliant and such an important tool for their fellow students. Working with young people means the outputs stay true to the vision and words of the young people themselves. They should be very proud.” She continued: “The LifeLab Youth Panel is an asset to our work with local schools and colleges and gives students a real insight into work at the University and University Hospital Southampton.”

Southampton researchers have urged the government to consider how to better support people in preparing for pregnancy and parenthood across the UK. Speaking at a government taskforce, Prof Keith Godfrey pressed the need for more support before pregnancy for women from ethnic minority groups and those living in deprived areas. The time before pegnancy is known as 'preconception'. He has said that providing better support during this time could improve pregnancy outcomes for these mothers and their babies, alongside making an important contribution to reducing inequalities in health. Offering a solution Women in the UK from ethnic minority groups and women living in deprived areas tend to have worse pregnancy outcomes. Black women are 40% more likely to experience a miscarriage than white women, and there are higher rates of still births in many deprived areas. The government's Department for Health and Social Care runs the Maternity Disparities Taskforce. This aims to find out how the government can tackle these differences. Prof Godfrey leads the Nutrition, Lifestyle and Metabolism theme at the NIHR Southampton Biomedical Research Centre. He also co-chairs the UK Preconception Partnership, which aims to improve preconception care in England. He spoke at a recent Maternity Disparities Taskforce meeting. After presenting relevant research, he shared the vision of the UK Preconception Partnership. He urged the taskforce to consider preconception care as a solution. Prof Godfrey said: “The time before pregnancy represents a special opportunity to break the transgenerational transmission of behavioural and physiological risks that underlie ill-health, such as poor-quality diets, lack of physical inactivity, obesity and smoking. “Supporting and enabling all potential parents to optimise their preconception health will improve outcomes for the mother, for her pregnancy and for her children. "The Maternity Disparities Taskforce is playing a critical role in ensuring that real change can be made. The UK Preconception Partnership is committed to supporting this mission.” Listening to women The Preconception Partnership was established in 2018. It aims to translate evidence in a Lancet Series into clinical practice. It also intends to normalise the idea of preparing for a healthy pregnancy. The Maternity Disparities Taskforce was set up to tackle disparities for mothers and babies. It also aims to reduce maternal and neonatal deaths. It intends to do this by improving access to care around pregnancy for women from ethnic minorities and those living in the most deprived areas. The meeting considered pre-pregnancy care and guidance for Black women and women in deprived areas. Maria Caulfield, Minister for Women’s Health Strategy, said: “Regardless of race or background, everyone should receive the highest quality maternity care. “All stages of a woman’s life, from before she is pregnant to after delivery, are crucial to the health and wellbeing of both mother and baby. “Today we met with mothers and healthcare experts to ensure women from ethnic minorities and those from deprived areas have access the right care and support for their journey into parenthood – and are listened to throughout this experience. “We are considering the outcomes of the taskforce, and I will be monitoring progress closely to ensure real change can be made.”

University Hospital Southampton is using online questionnaires to help patients prepare for surgery. The new approach is based on years of research that shows that preparing well can improve wellbeing, reduce problems after surgery and speed up recovery. The perioperative team have started to use an online personal health record known as My Medical Record to learn more about surgery patients. They use this to help patients improve their health before an operation. The method has been developed and tested by researchers from the NIHR Southampton Biomedical Research Centre (BRC). The project was led by Prof Denny Levett and funded by NHS England. What is perioperative care? Perioperative care supports patients before, during and immediately after major surgery. It aims to help patients prepare for an operation by taking steps to improve their physical and mental health. This may involve quitting smoking, cutting down on alcohol, improving diet and doing more exercise. Health screening questionnaire Patients answer a series of questions about their medical conditions, diet and lifestyle. The perioperative team can then provide advice on the areas they need to work on, such as reducing alcohol or increasing exercise. They can refer patients to supervised exercise programmes in the community, dieticians, specialist medical teams or for psychological support as needed. Over 800 patients have completed the questionnaire so far. Those at most risk have been identified earlier, allowing better preparation for surgery. Read the full case study on the UHS Digital website. Learn more about the questionnaire in the video below.

A study led by Southampton researchers has developed a set of outcome measures for severe asthma. Severe asthma affects around 5-10% of patients with asthma. It can have a significant impact on quality of life, with many patients missing school or work due to the condition. The new measures will help researchers identify the most effective treatments for severe asthma and improve patient outcomes. The international team published their findings in the European Respiratory Journal. What are core outcome measures? Core outcome measures are a set of tools that should be used in all studies about a specific topic. Biological therapies can treat some types of severe asthma. However, researchers currently use different outcomes to assess their effectiveness. This makes it difficult for researchers and clinicians to work out which treatments are best. The new COMSA (Core Outcome Measure sets for Severe Asthma) will be used in future clinical trials. They will allow researchers to compare results between studies more easily. The COMSA include quality of life, asthma control, clinical outcome measures and healthcare resource use. Patient-centred research People living with severe asthma were at the centre of this research. One participant said: “There is nothing more demoralising than feeling you are ignored as the patient. Contributing to this process was rewarding, enjoyable and made me feel I could help other patients with severe asthma have a better experience than I have had as a patient.’’ Dr Ekaterina Khaleva, Clinical Research Fellow at the University of Southampton, led the research with Graham Roberts, Ratko Djukanovic and Anna Rattu. She said: “We wanted to ensure that our COMSA include outcomes that are important to each stakeholder group. “COMSA will harmonise the way outcome measures are reported in clinical studies. This will enable comparisons of data to produce meaningful results. “Working together with other stakeholder representatives is essential to succeed in the development of novel approaches to patient-centred management. We hope to help improve long-term outcomes of patients with severe asthma.’’ The study was funded by the European Commission’s Innovative Medicines Initiative 2. It was a collaboration between the University of Southampton and partners from across Europe and North America. Representatives included people living with severe asthma, health professionals, healthcare regulators, researchers and pharmaceutical companies.

Southampton researchers are launching the first trial of a pioneering weight-loss treatment. Healthy volunteers will test a self-expanding capsule designed to aid weight loss by reducing hunger. The hydrogel works like a gastric balloon but is designed to be safe, affordable and taken at home. Oxford Medical Products (OMP) has partnered with University Hospital Southampton NHS Foundation Trust (UHSFT) for the first-in-human trial, led by Chief Investigator James Byrne. OMP has today announced £1.25m from Innovate UK for the clinical trial. It is taking place at the NIHR Southampton Biomedical Research Centre (BRC) and Clinical Research Facility (CRF). A growing problem Around one in four adults in the UK now have obesity, which means having a BMI of 30 or above. Obesity can increase the risk of many other health conditions, including type 2 diabetes and some types of cancer. It costs the NHS billions of pounds each year. However, current treatments are too expensive and resource-intensive to tackle the scale of the problem. OMP aims to provide an affordable and effective treatment that could help people lose weight. Dr Camilla Easter, Chief Executive Officer of OMP, explained: “Our aim is to develop a weight-loss solution that empowers people to successfully lose weight and maintain a healthy weight long term. “We have developed a scalable solution that can be taken at home. It could ultimately be made available to hundreds of millions of people living with excessive weight. “This Innovate UK grant helps to support the later phase of our pilot clinical trial. It will ensure the right data is generated to allow OMP to accelerate towards pivotal trials and regulatory approval.” Pioneering new treatment The trial is funded by Innovate UK’s Biomedical Catalyst competition. It follows successful pre-clinical development of the hydrogel-based weight-loss treatment. Mr James Byrne (MD, FRCS), a consultant surgeon at UHS and Chief Investigator for the first-in-human clinical trial said: “I am excited to be working with Oxford Medical Products who, through Sirona, have developed a completely original approach to the serious problem of obesity. “Our research team at the National Institute for Health and Care Research (NIHR) Southampton BRC are working with research leaders at the University of Oxford to evaluate this intervention with cutting edge technology and digitally driven data capture. “I am very proud to be in the team performing this critically important research.” Taking part The trial is being delivered locally by the NIHR Southampton CRF based at UHSFT. To join this clinical trial, you must be: Aged between 18 and 65 Have a BMI of 30-40 Willing to travel to Oxford for MRI visits You must not be on any long-term treatments or have had weight loss surgery. For more information, please contact SIRONASTUDY@uhs.nhs.uk or call 023 8120 5961/023 8120 4911.

The risk of respiratory problems after COVID-19 increases with age and longer hospital stays, according to new research. An understanding from this research could help doctors to identify which patients most need a follow-up appointment. The study was driven by experts from the University of Southampton, University Hospital Southampton (UHS) and the NIHR Southampton Biomedical Research Centre (BRC). Their findings are published in Respiratory Research. Five-point ‘risk score’ UK patients are advised to have a follow-up appointment and chest X-ray 12 weeks after being hospitalised with COVID-19. In a previous study, Southampton researchers found persistent chest problems are common at this stage. They devised a five-point ‘risk score’ that strongly predicted who was most likely to be affected. Risk factors included length of hospital stay, obesity and smoking status. This latest study aimed to confirm their findings in a new cohort. COVID-19 data Researchers analysed information from 182 patients’ follow-up appointments at UHS. Around one third (31%) had ongoing chest problems, such as scarring of the lung. The data is from the Research Evaluation Alongside Clinical Treatment in COVID-19 study (REACT COVID). REACT COVID was supported by the NIHR Southampton Clinical Research Facility and BRC. Dr Anna Freeman, REACT COVID co-lead, is also involved in the new research. She explained: “We collected routine clinical data for patients admitted to UHS with COVID-19 at the start of the pandemic in March 2020, with additional sampling for research if patients were happy to consent. “It has enabled important research to help identify patients at risk of severe disease. Understanding risk factors for severe disease early in the pandemic was key to improving treatments and reducing critical care demand. "It could also be helpful in risk stratification for potential future pandemics.” Increased risk factors The analysis found that risk of long-term chest problems after COVID-19 increased with age and longer hospital stays. Those affected were significantly older (64 years vs 55 years) and had stayed in hospital for longer (10.5 days vs 7 days). People with a history of smoking were also at higher risk. However, there was no association between obesity and likelihood to experience ongoing problems. Dr Ben Marshall, senior author of the paper, said: “This study provides clear evidence in support of the ‘risk score’ we have developed. “It can predict which COVID-19 patients will experience long-term chest problems, saving clinical time. It could potentially be a useful adjunct for future respiratory virus pandemics.” He added: “The results are a testament to our fantastic respiratory team in Southampton. Their extraordinary efforts throughout the pandemic enabled this research.” Dr Tim Wallis, first author of the paper, said: “We were delighted to receive funding from the UHS R&D small grants scheme for this project. “Further research will aim to understand patients’ experience and expectations of their COVID follow-up clinic journey. This could help inform future pandemic follow-up service design.”

Visitors of all ages learned how research is life-changing at Southampton Science and Engineering Day. Thousands of people joined the celebration at the University of Southampton on Saturday. They entered hands-on activities, workshops, live shows, talks and tours. Health researchers, staff and volunteers exhibited from the Southampton Centre for Research Engagement and Impact. They were based in the Centenary Building on Highfield Campus. Families were invited to ‘be part of something life-changing… research’. They learned how research is improving current medicines, treatments and care. Heather Parsons, Patient and Public Involvement and Engagement Lead, said: “We have fantastic researchers, scientists and academics who all have excellent ideas for creating research programmes. But if they don’t hear the lived experiences of the public they can never be completely sure that they’re delivering research that helps everybody.” Hear from voices across the day in our audio clip, below.