This is an open-label, single-center, randomized, split-face, controlled study to assess the effect of comfort intervention on pain during treatment injection compared against non-comfort intervention.

开始日期2023-10-23

申办/合作机构

DeNova Research

NCT05730543 / Completed临床3期IIT

Ethnic Lip Augmentation With Hyaluronic Acid Filler: Utilization of a Validated Lip Fullness Scale and Determining Pre Injection Lips Size Preference and Post Injection Patient Satisfaction

Lip augmentation using hyaluronic acid filler in females with Fitzpatrick skin type V-VI

开始日期2022-11-01

申办/合作机构

DeNova Research

NCT05343559 / CompletedN/AIIT

The Influence of a Mask on the First Impressions Projected and Attractiveness Levels of Smiling Individuals

Evaluation on the effects of smiling on first impressions and attractiveness with and without wearing a facial surgical mask.

开始日期2022-03-04

申办/合作机构

DeNova Research

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0 项与 DeNova Research 相关的专利（医药）

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项与 DeNova Research 相关的文献（医药）

2024-09-01·Dermatologic Surgery

A Review of Current Data on Duration of Effect in Glabellar Lines After Treatment With AbobotulinumtoxinA 50 U

Review

作者: Cox, Sue Ellen ; Dayan, Steven ; Kaufman-Janette, Joely ; Cohen, Joel L. ; El-Qadi, Sami ; Joseph, John ; Prygova, Inna ; Persson, Cecilia ; Glaser, Dee Anna ; Jacob, Carolyn ; Schlessinger, Joel ; Moradi, Amir

BACKGROUNDAbobotulinumtoxinA has become well established as a treatment option for moderate to severe glabellar lines since its first aesthetic approval in 2009.OBJECTIVEPivotal trials leading to regulatory approval showed that abobotulinumtoxinA treatment was associated with high responder rates when defined as achievement of none or mild glabellar lines (0 or 1 on the glabellar line severity scale) and a duration of action of up to 5 months. More recently, the goals for treatment of glabellar lines have shifted toward not only achieving a decrease in glabellar line severity but also ensuring that patients are satisfied with their experience.MATERIALS AND METHODSPatients seek an improvement in the appearance of their glabellar lines while maintaining a “natural look,” fast onset of effect, and long duration of response.RESULTSTrial designs have evolved to meet these new targets, including expanding the definition of responders to those having at least 1-grade improvement in the glabellar line severity scale score from baseline coupled with the use of subject satisfaction and psychological well-being questionnaires.CONCLUSIONThe findings demonstrate that abobotulinumtoxinA remains a well-tolerated and consistently effective treatment option associated with a rapid onset of effect, duration of efficacy lasting up to 6 months, and high, long-lasting levels of patient satisfaction.

2024-06-01·Dermatologic Surgery

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials

Article

作者: Pueraro, Elena ; Taylor, Susan ; Kaufman-Janette, Joely ; Joseph, John ; Zhou, Jihao ; Cecerle, Michael ; Rzany, Berthold ; Gold, Michael ; Dayan, Steven ; Irvine, Ryan ; Cohen, Joel L. ; Cox, Sue Ellen ; Nestor, Mark S.

BACKGROUNDHyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem.OBJECTIVETo evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials.MATERIALS AND METHODSBaseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points.RESULTSAmong enrolled and treated subjects (N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was −33.84 for letibotulinumtoxinA subjects compared with −1.37 for placebo subjects (p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity (p < .0001).CONCLUSIONLetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome.

2024-06-01·Facial Plastic Surgery & Aesthetic Medicine

Artificial Intelligence Versus Expert Plastic Surgeon: Comparative Study Shows ChatGPT “Wins” Rhinoplasty Consultations: Should We Be Worried?

Article

作者: Kim, Roy ; Durairaj, K Kay ; Robotti, Enrico ; Dayan, Steven ; Karimi, Kian ; Bertossi, Dario ; Baker, Omer ; Rosengaus, Frank ; Most, Sam

Introduction: Large language models, such as ChatGPT, hold tremendous promise to bridge gaps in patient education and enhance the decision-making resources available online for patients seeking nasal surgery. Objective: To compare the performance of ChatGPT in answering preoperative and postoperative patient questions related to septorhinoplasty. Methods: Two sets of responses were collected for the questions: one from an expert rhinoplasty surgeon with over two decades of experience, and the other from ChatGPT-3.5. Seven expert rhinoplasty surgeons, blinded to the source of responses, independently assessed the responses using a 5-point Likert scale in four performance areas: empathy, accuracy, completeness, and overall quality. Results: ChatGPT outperformed physician responses in three of the four performance areas, earning significantly higher ratings in accuracy, completeness, and overall quality (p < 0.001). In addition, ChatGPT was overwhelmingly preferred over physician responses (p < 0.001), with evaluators favoring ChatGPT in 80.95% of instances. Conclusions: ChatGPT has demonstrated its remarkable ability to deliver accurate, complete, and high-quality responses to preoperative and postoperative patient questions. Although certain improvements are warranted, this artificial intelligence tool has shown its potential to effectively counsel and educate prospective septorhinoplasty patients at a level comparable with or exceeding that of an expert surgeon.

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