Contemporary Clinical Trials Communications最新文献

{"title":"Challenges and lessons learned in recruiting participants for school-based disease prevention programs during COVID-19","authors":"Yelena P. Wu ,&nbsp;Elise K. Brunsgaard ,&nbsp;Nic Siniscalchi ,&nbsp;Tammy Stump ,&nbsp;Heather Smith ,&nbsp;Douglas Grossman ,&nbsp;Jakob Jensen ,&nbsp;David B. Buller ,&nbsp;Jennifer L. Hay ,&nbsp;Jincheng Shen ,&nbsp;Benjamin A. Haaland ,&nbsp;Kenneth P. Tercyak","doi":"10.1016/j.conctc.2024.101399","DOIUrl":"10.1016/j.conctc.2024.101399","url":null,"abstract":"<div><div>Schools provide an ideal setting for delivery of disease prevention programs due to the ability to deliver health education and counseling, including health behavior interventions, to large numbers of students. However, the remote and hybrid learning models that arose during the coronavirus (COVID-19) pandemic created obstacles to these efforts. In this article, we provide insights on collaborating with schools to deliver disease prevention programming during the height of the COVID-19 pandemic, and in subsequent years. We illustrate these strategies by drawing upon our firsthand research experiences engaging high schools in a school-based cancer prevention trial focused on sun safety. Delivery of a cluster-randomized trial of a school-based skin cancer prevention program was initiated in the spring of 2020 at the onset of the COVID-19 pandemic in the U.S. We present multilevel evaluation data on strategies used to reach schools remotely and share lessons learned that may inform similar approaches moving forward during times of crises. Although the COVID-19 pandemic interrupted school-based recruitment for this trial, enrollment improved one year later and did not appear to differ between rural and urban schools. Recruitment strategies and trial-related procedures were modified to address new challenges brought about by the pandemic. Despite the COVID-19 crisis altering US classrooms, disease prevention programming can continue to be offered within schools, given close community partnerships and new adaptations to the ways in which such programming and research are conducted.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101399"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11652739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using community engagement with FRAME: Framework for reporting adaptations and modifications to evidence-based interventions","authors":"Jordana L. Clayton ,&nbsp;Rebecca L. Utz ,&nbsp;Nancy Aruscavage ,&nbsp;Sara G. Bybee ,&nbsp;Sharon E. Bigger ,&nbsp;Eli Iacob ,&nbsp;Kara B. Dassel","doi":"10.1016/j.conctc.2024.101398","DOIUrl":"10.1016/j.conctc.2024.101398","url":null,"abstract":"<div><div>Community engagement is increasingly considered a key component of intervention development, as it can leverage community members’ knowledge, experiences, and insights to create a nuanced intervention which meets the needs, preferences, and realities of the population of interest. Community engagement exists along a spectrum from outreach to the community to partnership with community members and organizations, and all levels of community engagement can benefit from systematic documentation of community feedback and decision-making processes. This paper demonstrates how we utilized the “Framework for Reporting Adaptations and Modifications to Evidence-based Interventions” (FRAME; Wiltsey Stirman et al., 2019) model to track and report adaptations to our dementia end-of-life care planning intervention based on community engagement via a project-specific Community Advisory Board (CAB). Using FRAME, we generated a comprehensive report of the iterative changes made to our pilot intervention, including whether the change was planned, who made the decision to modify the intervention, the nature of the change, its relationship to intervention fidelity, and the reason for the change. This process ensured that we effectively integrated feedback and assistance from our CAB, increased the appropriateness of our intervention for our population of interest, established criteria to monitor intervention fidelity, and prepared our team to run a rigorous clinical trial of the revised intervention. Clinical Trial Registration Number: NCT05909189.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101398"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A simple blinding index for randomized controlled trials","authors":"David Petroff ,&nbsp;Miroslav Bacak ,&nbsp;Nikolaos Dagres ,&nbsp;Patrick Dilk ,&nbsp;Rolf Wachter","doi":"10.1016/j.conctc.2024.101393","DOIUrl":"10.1016/j.conctc.2024.101393","url":null,"abstract":"<div><div>Blinding is an essential part of many randomized controlled trials. However, its quality is usually not checked, and when it is, common measures are the James index and/or the Bang index. In the present paper we discuss these two indices, providing examples demonstrating their considerable weaknesses and limitations, and propose an alternative method for measuring blinding. We argue that this new approach has a number of advantages. We also provide an R-package for computing our blinding index.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101393"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142744574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Examining recollections of Black women with breast cancer who participated in clinical trials: A grounded practical theory study of patient-provider communication","authors":"Katherine E. Ridley-Merriweather ,&nbsp;Oseme Precious Okoruwa ,&nbsp;Katherine Vogel","doi":"10.1016/j.conctc.2024.101403","DOIUrl":"10.1016/j.conctc.2024.101403","url":null,"abstract":"<div><div>The presence of strong barriers to research participation for Black women is indisputable. However, existing evidence supports the possibility of equal levels of participation among members of minoritized populations in past breast cancer (BC) clinical trials (CTs), demonstrating that while these participation barriers undoubtedly exist but are not insurmountable. This work aims to investigate patient-provider conversations to try to illuminate how providers can better engage Black women in communication that will positively influence their perceptions of breast cancer clinical trial participation. Fourteen women (N = 14) who self-identified as Black, Black American, or African American and who had previously or were currently involved in a BC CT participated in the grounded theory-guided study. These women were recruited through emails and social media platforms and interviewed regarding their communication with their medical providers and their pathway to CT participation. Findings revealed three primary categories: 1) participants reported the following provider types as most effective communicators: attentive, matter-of-fact, warm, or above-and beyond; 2) participants frequently received no information about CTs from their providers; and 3) cultural constructs including faith, word of mouth, and storytelling are important to the recruitment of these Black women to BC CTs. Our findings demonstrate the importance of healthcare providers adjusting their communication to meet one of the preferred provider archetypes of communication styles, understanding and incorporating cultural constructs in their communication, and providing information about BC CTs to Black women. Through improved patient-provider communication, healthcare providers may positively influence Black women's perceptions of and participation in BC CTs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101403"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142744573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TEleRehabilitation foR Aphasia (TERRA) phase II trial design","authors":"Christy Cassarly ,&nbsp;Alexandra Basilakos ,&nbsp;Lisa Johnson ,&nbsp;Janina Wilmskoetter ,&nbsp;Jordan Elm ,&nbsp;Argye E. Hillis ,&nbsp;Leonardo Bonilha ,&nbsp;Chris Rorden ,&nbsp;Gregory Hickok ,&nbsp;Dirk-Bart den Ouden ,&nbsp;Julius Fridriksson","doi":"10.1016/j.conctc.2024.101406","DOIUrl":"10.1016/j.conctc.2024.101406","url":null,"abstract":"<div><h3>Background and purpose</h3><div>Despite comprehensive evidence that supports the utility of aphasia therapy in persons with chronic (≥6 months) stroke-induced aphasia, the amount of therapy provided to patients in the United States is typically far less than what is likely necessary to maximize recovery. Two potential contributors to this discrepancy are limited access to rehabilitation services due to the availability of providers and logistical difficulties with transportation. One way to increase access to aphasia therapy is to rely on telerehabilitation.</div></div><div><h3>Methods</h3><div>The TEleRehabilitation foR Aphasia (TERRA) trial is a prospective, randomized, rater-blinded, multicenter phase II non-inferiority trial to evaluate telerehabilitation for aphasia therapy in persons with chronic post-stroke aphasia. Participants are randomized (1:1) to receive either aphasia remote therapy or in-clinic therapy for 30 total days of treatment (15 days of a semantically focused approach and 15 days of a phonologically focused approach) for 45 min per day. A total of 100 adults (ages 21–80) with a history of left hemisphere ischemic or hemorrhagic stroke incurred at least 12 months prior to study enrollment will be randomized. The trial will be conducted at the clinical research facilities at two sites: the Medical University of South Carolina and the University of South Carolina.</div></div><div><h3>Conclusions</h3><div>This paper details the design of the TERRA trial, which aims to test whether aphasia therapy delivered by a remote speech-language pathologist through videoconferencing (i.e., via telerehabilitation) is not clinically worse than in-clinic therapy for individuals with chronic post-stroke aphasia to provide an opportunity to move to a definitive phase III trial.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101406"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142757564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hydroxyurea therapy for neurological and cognitive protection in pediatric sickle cell anemia in Uganda (BRAIN SAFE II): Protocol for a single-arm open label trial","authors":"Vincent Mboizi ,&nbsp;Catherine Nabaggala ,&nbsp;Deogratias Munube ,&nbsp;John M. Ssenkusu ,&nbsp;Phillip Kasirye ,&nbsp;Samson Kamya ,&nbsp;Michael G. Kawooya ,&nbsp;Amelia Boehme ,&nbsp;Frank Minja ,&nbsp;Ezekiel Mupere ,&nbsp;Robert Opoka ,&nbsp;Caterina Rosano ,&nbsp;Richard Idro ,&nbsp;Nancy S. Green","doi":"10.1016/j.conctc.2024.101404","DOIUrl":"10.1016/j.conctc.2024.101404","url":null,"abstract":"<div><h3>Background</h3><div>Children with sickle cell anemia (SCA) in Sub-Saharan Africa are at high risk of sickle cerebrovascular injury (SCVI). Hydroxyurea, a commonly used disease-modifying therapy, may reduce SCVI resulting in potential impact on reducing stroke and cognitive dysfunction. We aim to test the impact of daily hydroxyurea therapy on these outcomes in Ugandan children with SCA. We hypothesized that hydroxyurea therapy over 36 months will prevent, stabilize or improve these complications of SCA.</div></div><div><h3>Methods</h3><div>The BRAIN SAFE II study is an open label, single arm trial of daily hydroxyurea in 270 children with SCA (HbSS) in Uganda, ages 3–9 years. Following baseline assessments, participants began hydroxyurea therapy and are followed according to local guidelines. Standard hydroxyurea dose is escalated to maximum tolerated dose (MTD). SCVI is assessed by cerebral arterial velocity using Doppler ultrasound, with cognitive function determined by formal neurocognitive testing (primary outcomes). Structural SCVI is assessed by magnetic resonance imaging (MRI) and angiography (MRA) in a sub-sample of 90 participants ages &gt;5 years. At trial midpoint (18 months) and completion (36 months), outcomes of age-specific assessments will be compared to baseline, as well as biomarkers of anemia, inflammation and malnutrition (secondary outcomes) to determine their relationships to primary outcomes.</div></div><div><h3>Conclusion</h3><div>This trial will examine the impact of hydroxyurea on preventing or ameliorating SCA SCVI in children, assessed by reducing incident stroke, stroke risk and neurocognitive dysfunction. Trial results will provide critical insight into the role of hydroxyurea therapy on critical manifestations of SCVI in children with SCA.</div></div><div><h3>Trial registration</h3><div><span><span>https://clinicaltrials.gov/ct2/show/NCT04750707</span><svg><path></path></svg></span> (registered 11 February 2021).</div></div><div><h3>Protocol version</h3><div>BRAIN SAFE II Protocol Version 3.0, Mar 02, 2022.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101404"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664125/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical study of Jianpi Qingchang decoction in the treatment of ulcerative colitis patients with spleen deficiency and dampness-heat syndrome accompanied by fatigue: Study protocol for a randomized controlled trial","authors":"Zi-Xuan Liu ,&nbsp;Xiao-Yan Liu ,&nbsp;Wei-wei Tan ,&nbsp;Wei-Bing Zhang ,&nbsp;Ya-Li Zhang ,&nbsp;Lie Zheng ,&nbsp;Yan-Cheng Dai","doi":"10.1016/j.conctc.2024.101409","DOIUrl":"10.1016/j.conctc.2024.101409","url":null,"abstract":"<div><h3>Background</h3><div>Ulcerative colitis (UC) is a chronic non-specific inflammatory intestinal disease, categoried under \"dysentery\" and \"intestinal bleeding\" in Traditional Chinese Medicine (TCM). Jianpi Qingchang decoction (JPQC) is a combination formula specifically designed for the treatment of UC. The primary objective of this study is to examine the clinical efficacy of JPQC in individuals diagnosed with UC who exhibit both spleen deficiency and dampness-heat syndrome, along with the presence of fatigue. The investigation will focus on assessing the impact of JPQC on the gut microbiota and metabolites in these patients, aiming to elucidate the regulatory mechanism that JPQC exerts on the gut microbiota and metabolites in the context of UC-related fatigue.</div></div><div><h3>Methods</h3><div>In this randomized clinical trial, 140 subjects diagnosed with UC will be recruited and randomized into two groups. They will receive either JPQC combined with mesalazine or mesalazine alone for 12 weeks. Follow-up visits will be conducted every four weeks, with a post-treatment visit scheduled at 6 months. The primary outcome measures include the Inflammatory bowel disease fatigue scale(IBD-F). Secondary efficacy indicators comprise the assessment of TCM syndrome and individual syndrome efficacy before and after treatment, Modified Mayo score, Simple clinical colitis activity index (SCCAI), as well as the Inflammatory Bowel Disease Questionnaire (IBDQ) for each group. The other outcomes are the Intestinal microbial diversity and non-targeted metabonomics, which will be measured at baseline and 12 weeks after randomization.</div></div><div><h3>Discussion</h3><div>If effective, JPQC will provide substantial clinical evidence concerning the effectiveness and safety in the treatment of patients with UC experiencing spleen deficiency and dampness-heat syndrome accompanied by fatigue.</div></div><div><h3>Trial registration</h3><div>ChiCTR2300068348.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101409"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11681875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142903724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Involving youth with intellectual and/or developmental disabilities as collaborators in a comparative effectiveness trial: A community-engaged research approach","authors":"K.L. Berg ,&nbsp;D Herrman ,&nbsp;L Bernard ,&nbsp;C.S Shiu ,&nbsp;I Mihaila ,&nbsp;C Arnold ,&nbsp;K Acharya ,&nbsp;T.R.G Gladstone ,&nbsp;C Danguilan ,&nbsp;H Gussin ,&nbsp;P Perez ,&nbsp;A Herrman ,&nbsp;S Aaron ,&nbsp;A Thornton ,&nbsp;M Gerges ,&nbsp;C Patriarca ,&nbsp;J.J Pak ,&nbsp;B.W Van Voorhees","doi":"10.1016/j.conctc.2024.101395","DOIUrl":"10.1016/j.conctc.2024.101395","url":null,"abstract":"<div><h3>Background</h3><div>Practices to include youth with intellectual and/or developmental disabilities (IDD) are necessary to design and implement research that specifically meets the behavioral health needs of this population. This article describes a protocol for engaging youth with IDD as collaborators in a comparative effectiveness clinical trial using a community-engaged research (CEnR) approach.</div></div><div><h3>Methods</h3><div>Our engagement protocol, guided by the Community Engaged Research (CEnR) Framework, emphasized harm avoidance, accessibility, demonstrated value, capacity bridging and co-learning, shared power and equity in decision-making, accountability and respect, and transparent communication. We involved seven youth with IDD in a Youth Advisory Committee (YAC) and four youth with IDD in a Summer Scholars program, ensuring consistent and structured engagement throughout the study.</div></div><div><h3>Results</h3><div>Youth with IDD maintained high levels of engagement in both the YAC and Summer Scholars Program with 100 % retention across two years. Youth used multiple modalities to provide feedback on aspects of the research project, resulting in study modifications, the co-development of products, and tangible improvements in the accessibility and relevance of the study for youth with IDD.</div></div><div><h3>Conclusion</h3><div>Researchers and clinicians seeking to engage the historically underserved population of disabled youth in clinical trial research can leverage our findings to enhance the accessibility and inclusivity of their studies.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101395"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142744572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of crisis response planning and treatment as usual for active duty service members at risk for suicide: Study protocol for a stepped-wedge cluster randomized trial in a military treatment facility","authors":"Kristen H. Walter ,&nbsp;Pia R. Khandekar ,&nbsp;Alexander C. Kline ,&nbsp;Erin L. Miggantz ,&nbsp;Nicholas P. Otis ,&nbsp;Lisa H. Glassman ,&nbsp;Cynthia J. Thomsen ,&nbsp;Guy Brock ,&nbsp;Craig J. Bryan","doi":"10.1016/j.conctc.2024.101407","DOIUrl":"10.1016/j.conctc.2024.101407","url":null,"abstract":"<div><h3>Background</h3><div>Suicide is one of the leading causes of death among U.S. service members, and rates of suicide among military personnel have increased over the past two decades. To address this serious issue, effective preventive treatments are needed in settings where at-risk service members are frequently seen, such as emergency departments and inpatient psychiatric units. This study will compare the longitudinal effects of crisis response planning (CRP) and treatment as usual (TAU) on suicidal thoughts and behaviors among active duty service members seeking emergent care for suicidality at a military treatment facility.</div></div><div><h3>Methods</h3><div>The current study is conducted through a consortium, Augmenting Suicide Prevention Interventions for Service Members. This article details an ongoing stepped-wedge cluster randomized clinical trial that compares rates of suicidal thoughts and behaviors among service members at risk for suicide following care from CRP-trained providers versus untrained providers (i.e., TAU). Participants complete assessments at pretreatment and every 3 months up to 1 year. Primary outcomes include suicide attempts and behaviors, and suicidal ideation is a secondary outcome. Moderators of treatment effects will also be examined. The methodological development of this trial is discussed, along with clinical and ethical considerations for suicide prevention research in emergency, inpatient, and military treatment settings.</div></div><div><h3>Conclusion</h3><div>Providing evidence-based treatment for suicidality that addresses service members’ unique needs is crucial to reduce suicide rates and facilitate mental health recovery in this population. This study aims to inform future implementation and dissemination of CRP in healthcare systems to ultimately decrease suicide among service members.</div></div><div><h3>Clinical trials identifier</h3><div>NCT05795764.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101407"},"PeriodicalIF":1.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11681889/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142903734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effects of alpha-lipoic acid transdermal patch for local subcutaneous fat reduction: A randomized, placebo-controlled, clinical trial in overweight volunteers","authors":"Kanidta Sooklert ,&nbsp;Sasin Thamakaison ,&nbsp;Siwaporn Nilyai ,&nbsp;Sarocha Cherdchom ,&nbsp;Rojrit Rojanathanes ,&nbsp;Amornpun Sereemaspun","doi":"10.1016/j.conctc.2024.101402","DOIUrl":"10.1016/j.conctc.2024.101402","url":null,"abstract":"<div><h3>Background</h3><div>Combating obesity is challenging, as anti-obesity compounds lose effectiveness or cause severe side effects when delivered via conventional routes. Thus, there is a need for new, effective treatment routes that are home-based and safe for long-term use. This double-blind, placebo-controlled clinical trial aimed to investigate the efficacy of a biocellulose transdermal patch containing α-lipoic acid (ALA), an anti-obesity compound, in reducing subcutaneous fat accumulation.</div></div><div><h3>Methods</h3><div>One hundred and sixteen overweight participants (average age 37.96 ± 7.80 years) were recruited for the study. They were randomly assigned to apply either the calcium citrate nanoparticle-encapsulated ALA transdermal patch or a placebo on their arm. The participants’ body weight, height, blood lipid profile (cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein), arm circumference, triceps skin fold, and subcutaneous fat thickness were recorded at baseline and at the 2-week follow-up.</div></div><div><h3>Results</h3><div>The mean arm circumference did not show any significant difference from baseline, whereas the triceps skinfold and subcutaneous fat thickness showed a significant reduction. The 2-week treatment did not significantly alter the plasma LDL, HDL, and triglyceride levels of the participants, but it significantly reduced the total cholesterol level.</div></div><div><h3>Conclusion</h3><div>This study reports the successful reduction of subcutaneous fat of the calcium citrate nanoparticle-encapsulated ALA transdermal patches. The transdermal patches could be used as a safe and effective home-based solution for combating obesity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101402"},"PeriodicalIF":1.4,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142721253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}