Tennessee Clinical Research Center

ABSTRACTBackgroundCellulite is a common aesthetic condition of the skin, predominantly affecting more than 90% of postpubertal females. Energy‐based devices (EBDs) have demonstrated efficacy in treating a variety of dermatologic concerns. A controlled thermal injury to the dermis can stimulate remodeling of the extracellular matrix (ECM), leading to skin tightening, an effect that may improve the dimpled appearance of cellulite.ObjectiveTo assess the efficacy and safety of synchronous parallel ultrasound using a high‐density handpiece for improving cellulite appearance.Materials and MethodsSixty subjects, aged 23–65, were enrolled in a prospective, open‐label, non‐randomized, multicenter study. Subjects underwent two treatment sessions using a novel ultrasonic system equipped with a new high‐density handpiece, applied on either one side or both sides of the thighs and/or buttocks. The follow‐up period extended up to 3 months after the second treatment. Clinical improvements were evaluated by three blinded physicians based on baseline and follow‐up photographs, using the Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and Laxity Scale (LS). Satisfaction questionnaires were completed by subjects. Treatment discomfort was rated immediately after treatment using the Numerical Scale Response (NSR).ResultsSixty subjects, with a mean age of 47, were enrolled in the study. GAIS results showed improvement in 91% of the treated areas, CSS score improved by 69%, while LS score improved by 53%. Most subjects (73%) reported satisfaction. Mean pain score was 4.26 ± 2.33. No serious adverse events were reported.ConclusionThe novel ultrasound system was found to be effective and safe for improving cellulite appearance.

As the 8 patient partners serving on the PCORnet® Steering Committee, we stand at the forefront of a transformative movement in clinical research. PCORnet® Network Partners have been pioneers in integrating patient voices into every aspect of the research process, and we applaud the progress in operationalizing the Patient-Centered Outcomes Research Institute’s (PCORI) Framework for Patient Engagement and for leading the way as funders to change how to effectively involve patients and other interested parties in research. However, we believe that now is the time to amplify our efforts and call for a fundamental shift in how health research is conducted across the board. This commentary serves as both a reflection on our journey and a rallying cry for deeper, more authentic patient engagement and partnership in clinical research. The landscape of clinical research has undergone significant changes over the past decade, with patient engagement emerging as a cornerstone of patient-centered outcomes research. This shift is evidenced by major funding agencies now requiring patient engagement and a growing body of literature demonstrating improved study quality, recruitment, and relevance when patients are engaged as partners. As patient partners participating in PCORnet®, we have been at the forefront of this evolution, witnessing firsthand the progress made and the challenges and learnings that remain. Drawing on our experiences and evidence from the literature, we propose strategies to enhance patient involvement across all stages of research. We introduce and explore the concept that clinical research should be “careful, kind, and connected.” Our reflections underscore that meaningful patient involvement is essential for advancing health outcomes and achieving a truly patient-partnered research ecosystem.

Opioids are often indicated after orthopedic surgery, but guidance on how to incorporate patient-specific risks into opioid prescribing is limited, and overprescribing can place patients at risk. Pharmacists are known to enhance patient care in the ambulatory care setting but may be underutilized in the perioperative care setting. The objectives of this retrospective multisite quality initiative (QI) project were to describe interventions by pain clinical pharmacist practitioners (CPPs) during perioperative visits and acceptance of recommendations by orthopedics teams. The secondary objectives included assessment of analgesic efficacy, describing opioid utilization and disposal, unplanned healthcare resource utilization or mortality at 30 days after surgery, and orthopedic team satisfaction with the service. Descriptive analysis was performed. Over the course of 10 months, 289 patients undergoing orthopedic surgery received perioperative care by pain CPPs, for a total of 1,395 preoperative interventions and 624 postoperative interventions. Postoperative recommendations were accepted by the orthopedic teams 50% of the time. Nearly all team members agreed or strongly agreed that a CPP should become a permanent part of the team. A CPP-run perioperative pain management clinic provides patient-specific pain management plans, opioid risk mitigation, and is well received by orthopedic teams.

Background: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated efficacy in the treatment of acne, with a good safety/tolerability profile, in participants with moderate to severe acne. Acne clinical presentation and response to treatment may differ between males and females as well as between pediatric-postadolescent (<24 years) and adult (≥25 years) patients. The objective of this post hoc analysis was to evaluate the impact of age and sex on the efficacy and safety of CAB gel. Methods: In one phase 2 and two phase 3 double-blind, 12-week studies, participants with moderate-to-severe acne were randomized to once-daily CAB or vehicle (Veh). Data were analyzed post hoc for participants categorized by age and sex: females 9-24 or ≥25 years (ns=274 and 121) and males 9-24 or ≥25 years (ns=241 and 21). Efficacy endpoints included treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 or 1 [clear/almost clear]) and reductions from baseline in inflammatory and noninflammatory lesions (IL/NIL). Treatment-emergent adverse events (TEAEs) were also assessed. Results: At week 12, a greater percentage of participants in all sex/age subgroups achieved treatment success with CAB (42.3-54.1%) than Veh (15.0-22.5%). Similarly, lesion reductions were larger with CAB than Veh (IL: CAB, 75.9-77.8%; Veh, 50.8-65.2%; NIL: CAB, 69.7-73.7%; Veh, 44.5-55.2%). For all efficacy endpoints, CAB was statistically superior to Veh among males and females 9-24 years and females ≥25 years (P≤0.05, all). For males ≥25 years, only NIL reductions were significantly greater with CAB (P≤0.05), likely due to the small population. For all CAB-treated groups, most TEAEs were of mild-moderate severity. Rates of TEAEs deemed related to CAB treatment were similar for males and females 9-24 years (19.7% and 18.6%, respectively) and somewhat higher for females ≥25 years (24.4%). Considerably lower treatment-related TEAE rates in males ≥25 years (8.3%) may reflect the low number of participants in this group (n=12 treated with CAB). Conclusions: In 3 clinical trials, participants treated with CAB gel—the only fixed-dose, triple-combination topical for acne—experienced ≥70% lesion reductions, and approximately half achieved clear or almost clear skin. CAB gel demonstrated good efficacy and tolerability regardless of participants’ sex or age. Funding: Ortho Dermatologics

Androgenetic alopecia is the most common cause of hair loss that affects over 50% of the world population. It is a condition that is multifactorial in origin, with no specific causative factor, making treatment an enervating experience for the patient as well as the doctor. In recent times, a number of modalities have been introduced for the treatment of alopecia. However, the evidence supporting them is unstructured and sparse. Therefore, this article aims to explore the current trends in minimally invasive treatments for the management of androgenetic alopecia. An in-depth literature search on injectables used in the treatment of alopecia in PubMed/MEDLINE, Embase, PsycINFO, TRIP Cochrane Library, and Cochrane Skin databases between January 2000 and May 2023 was performed. The studies included were randomized controlled trials, non-randomized trials, quasi trials, single arm interventions, and cohort studies. Sixteen of the 1071 studies that were found during the original search were accepted in accordance with the inclusion criteria. Twelve studies assessed the effectiveness of the injectable group by comparing it to a control group consisting of saline, distilled water, and topical minoxidil. In the treatment of alopecia, dutasteride and injectable growth factor formulations achieved clinically significant results. The usage of injectables and topical medicines to treat hair loss has increased in the recent years. Overall results from clinical investigations, pilot studies, and trials looking at the efficacy and safety of these growth factors in the AGA show satisfactory efficacy.

Aesthetic medicine has traditionally relied on clinical scales for the objective assessment of baseline appearance and treatment outcomes. However, the scales focus on limited aesthetic areas mostly and subjective interpretation inherent in these scales can lead to variability, which undermines standardization efforts. The consensus meeting aimed to establish guidelines for AI application in aesthetic medicine. In February 2024, the AI Consensus Group, comprising international experts in various specialties, convened to deliberate on AI in aesthetic medicine. The methodology included a pre-consensus survey and an iterative consensus process during the meeting. AI's implementation in Aesthetic Medicine has achieved full consensus for enhancing patient assessment and consultation, ensuring standardized care. AI's role in preventing overcorrection is recognized, alongside the need for validated objective facial assessments. Emphasis is placed on comprehensive facial aesthetic evaluations using indices such as the Facial Aesthetic Index (FAI), Facial Youth Index (FYI), and Skin Quality Index (SQI). These evaluations are to be gender-specific and exclude makeup-covered skin at baseline. Age and gender, as well as patients' ancestral roots, are to be considered integral to the AI assessment process, underlining the move towards personalized, precise treatments. The consensus meeting established that AI will significantly improve aesthetic medicine by standardizing patient assessments and consultations, with a strong endorsement for preventing overcorrection and advocating for validated, objective facial assessments. Utilizing indices such as the FAI, FYI, and SQI allows for gender-specific, age adjusted evaluations and insists on a makeup-free baseline for accuracy.

Welcome to the latest issue of Dermatological Reviews—an issue devoted to one of the most interesting and exciting therapies emerging in our space—Regenerative Medicine space—PRP, Exosomes, and Stem Cells and their role in Aesthetics. All of these modalities have amazing clinical potential in medicine, and the aesthetics arena certainly has witnessed a great deal of buzz surrounding these topics over the past several years. When contemplating the topics that we choose to cover for Dermatological Reviews, we always try to find the most interesting and important topics that are in the dermatology arena. We also want to cover groundbreaking ideas, concepts, and Regenerative Medicine to fit into all of these categories. PRP has seen an increase in awareness and in science, and we are happy to be exploring its use in the aesthetic market. We are just breaking through the tip of the iceberg concerning the science of exosomes and the skin and where the most important indications and usages are for exosomes. Stem cells have also garnered much attention. Therefore, it is also important to understand them and their role in aesthetics. When we decided to choose Regenerative Medicine as the topic for this issue, the name of Dr. Jane Yoo immediately came to mind. Jane is an incredible dermatologist based in New York City and has a keen interest in this field—mainly the science behind Regenerative Medicine and how that translates into how we use them in our everyday clinical practices. We thank Dr. Yoo for accepting our invitation to be the Guest Editor for this issue of Dermatological Reviews, and she has done an amazing job of selecting authors and topics to cover this topic and the science that we must have to make it all real. We do hope that you enjoy this issue of Dermatologic Reviews and again, thank you Dr. Yoo.

Snail mucin is becoming increasingly popular for its wide range of ingredients and potential benefits. Snail extract's widespread appearance in cosmetic formulations encourages an investigation into the medical and cosmetic benefits. This study aims to explore current literature on the variety of snail mucin applications. Specifically, we present a review of the uses, global market estimates and projects, and limitations to snail mucin. A literature search was conducted on PubMed reviewing snail mucin and their application in medical and dermatologic fields examining their uses. Economic reports were also investigated for Global Market estimates. The therapeutic use of snail mucin in medical fields has been studied as antimicrobial agents, drug delivery vehicles, antitumor agents, wound healing agents, and biomaterial coatings among others. Additionally, the use in cosmetic fields includes antiaging, hydrating, anti-acne, scarring, and hyperpigmentation treatments. It is important to highlight that most studies conducted were preclinical or small clinical studies, stressing the need for additional large-scale clinical trials to support these claims. Investigations into the global market found estimates ranging from $457 million to $1.2 billion with upward projections in the upcoming decade. Limitations include ethical habitats for collection, allergy investigation, and missing clinical studies. The findings presented here emphasize the expanding uses of snail mucin and its ingredients alongside a growing market cosmetic industry should consider. We also emphasize the need for appropriate clinical trials into the stated benefits of snail mucin to ensure consumer safety and ethical extraction of mucin.

Background:Allograft adipose matrix (AAM) offers a novel, off-the-shelf, and readily available natural option in the treatment of facial soft tissue volume and reconstructive deficits. AAM is a natural soft tissue supplement or replacement that can support cushioning and volume correction. A prospective multicenter pilot study evaluated AAM in facial volume restoration.Methods:Eleven women (mean age of 55.8 ± 10.9 y) with midface volume deficit were followed up for 24 weeks after AAM treatment in this institutional review board–approved multicenter pilot study. The clinical safety and efficacy of the AAM treatment were evaluated using clinical scales and three-dimensional quantitative facial photography.Results:AAM was safe to address facial volume deficits, with minor site-related adverse events and discomfort that resolved within 2–4 weeks. Observations also revealed facial volume improvements throughout the study with 91% positive responders. At week 24, the subject facial satisfaction scores revealed an 86% increase compared to baseline, along with a statistically significantly improved midface fullness compared to baseline.Conclusion:AAM offers a natural and safe option for midface volume restoration and supports overall satisfaction and volume improvements.