Denova Research

In an evaluator-blinded, randomized controlled trial, the hyaluronic acid soft-tissue filler VYC-20L injectable gel was safe and effective for correcting volume deficits and retrusion in the chin. The objective of this subanalysis was to compare responder rates obtained with photographic vs live assessments. Participants were randomized 3:1 to VYC-20L treatment or a 6-month, no-treatment control period followed by optional treatment. Responder rates (≥1-point improvement from baseline on the validated Allergan Chin Retrusion Scale [ACRS]) obtained with photographic assessments and live assessments at Month 6 were compared. Prespecified subgroup analyses compared responder rates by baseline ACRS severity, filler volume, cannula usage, and investigation site. VYC-20L was effective for chin augmentation as evaluated with both live and photographic assessments. The ACRS responder rates at Month 6 were 91.8% with live assessments and 56.3% with photographic assessments. Consistently higher response rates were observed by live vs photographic assessment regardless of baseline ACRS severity, filler volume, cannula usage, and investigation site. Live assessment of ACRS response after VYC-20L treatment resulted in higher responder rates than photographic assessment, supporting the use of live assessment for this indication to approximate real-world clinical practice.

OnabotulinumtoxinA (onabotA) is indicated for upper facial lines (UFL). Fear of unnatural-looking outcomes is a frequently reported treatment barrier. Examine patient-reported outcomes (PROs) after onabotA treatment for UFL. A post hoc analysis was conducted on two 12-month pivotal studies of onabotA for forehead and glabellar lines (20 U each), with/without treatment of crow's feet lines (±24 U). This analysis used PROs from the Facial Line Satisfaction Questionnaire: Items 4 (natural look), 5 (treatment effect), 11 (met expectations), and Impact Domain (appearance and psychological impact). The analysis included 458 neurotoxin-naive adults achieving a ≥2-grade improvement in forehead line (FHL) severity on the Facial Wrinkle Scale at Day 30 (primary endpoint). [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'forehead line (FHL)' in this version.] Data were further stratified into millennials and men. At Day 30, 90.5% of all participants, 94.6% of millennials, and 85.7% of men were satisfied with receiving a natural look. Millennials had higher odds of being satisfied with natural outcomes at Day 30. This measure remained > 80% for all groups throughout the 12 months. Additionally, ≥80% were satisfied with the treatment effect, and >90% reported results met expectations. At Day 30, ≥50% reported positive impacts on self-perceived appearance and psychological well-being, but millennials had higher, and men had lower odds of reporting these improvements. Participants achieving a ≥2-grade improvement in FHL severity after onabotA reported high satisfaction with natural outcomes and the treatment effect, with improved self-perceived appearance and psychological well-being. [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'FHL' in this version.] These results may help aesthetic providers and patients address fears regarding unnatural results with onabotA.

Fractional carbon dioxide (CO2 ) laser resurfacing is used successfully for facial rejuvenation. Post procedure skincare is a variable that influences downtime caused by pain/tenderness, erythema, crusting, and bruising. The primary objective of this pilot study was to demonstrate the benefits of human platelet extract (HPE) (plated)™ CALM Serum, a new topical cosmetic product, following fractionated CO2 ablative laser resurfacing treatment to the entire face versus standard of care. In a single-center, randomized, evaluator-blinded pilot study, a total of 18 subjects were randomized into two groups, CO2 facial resurfacing followed by post-procedural standard of care (Stratacel silicone gel) or CO2 facial resurfacing with the addition of HPE renewosomes in the CALM Serum. CALM Serum demonstrated statistically significant less crusting at Day 10 compared to the control group (p = 0.0193) with less downtime in the first 14 days (p = 0.03). Subjects treated with CALM Serum had statistically significant brighter appearing skin at 14 days (p = 0.007) and more youthful looking skin on Days 14 and 30 (p = 0.003 and 0.04, respectively). This study demonstrates that Renewosome™ technology provides statistically significant post-laser clinical recovery over silicone gel for reducing crusting, and downtime. Subjects reported less diary days of symptoms of pain/tenderness, redness, crusting/flaking, bruising, and itching in the first 14 days compared to the control group. CALM also demonstrated statistically significant improvements in brighter and more youthful appearing skin. CALM is safe and well tolerated.

The popularity of social media appears to be increasing the acceptance of cosmetic treatments, prompting more consumers to seek cosmetic treatments. As the estimated prevalence of acne vulgaris among adult women may be as high as 54%, acne is commonly observed among patients presenting for cosmetic treatments. Concomitant treatment of acne in the aesthetic patient population will improve overall clinical outcomes. The goal of this work was to deliver a high-quality ethical and evidence-based educational program to physicians and adjunctive health care providers to advance patient care. This paper is based on a webcam presentation with roundtable discussion by several notable experts in their field. A range of topical medications, injectable products, chemical peels, and energy-based devices are available for treating acne vulgaris. In most instances, these are compatible with rejuvenation procedures in the aesthetic patient. The growth of social media is raising awareness of aesthetic procedures and appears to be increasing the number of patients seeking aesthetic treatment. Educating patients about the importance of treating acne vulgaris can improve overall treatment outcomes. In most instances, the presence of acne is not a barrier to aesthetic care.

Cosmetic procedures, especially cosmetic minimally invasive treatments, are rising in popularity, despite societal perception that these procedures may not improve patient health. The purpose of this study was to conduct a systematic review and controlled meta-analysis to compare the effects of cosmetic procedures and antidepressant treatment on health-related quality-of-life improvement. The PubMed database was queried in two independent searches to identify peer-reviewed cosmetic and antidepressant articles published between 1996 and 2017 that prospectively assessed the impact of the treatment on quality of life. All results were screened using defined exclusion and inclusion criteria and data were extracted using a standardized protocol. The meta-analysis was performed using a random-effects model. Five of 2,788 cosmetic studies and eight of 2,312 antidepressant studies met all inclusion criteria and utilized the 36-Item Short Form Health Survey (SF-36) measure. Except for the physical functioning scale, when compared with the cosmetic studies, antidepressant studies had significantly lower median baseline and post-treatment follow-up scale scores with larger median score improvement (p < 0.05). Positive effect sizes following treatment were observed for all eight SF-36 scales (range: 0.32-1.16; p < 0.05). This meta-analysis provides evidence that cosmetic procedures objectively improve a patient's health-related quality of life. While antidepressant studies exhibited greater SF-36 score improvement except for the physical functioning scale, both treatment groups demonstrated the greatest improvement in mental health and role emotional scales. As previously suggested, a disconnect exists between score improvement and clinical improvement due to baseline severity, ceiling effect, and regression to the mean effects.

Botulinum toxin was first described in the 1800's and has since found its permanent place in the medical community becoming the main ingredient of the most common cosmetic procedure.The injections have also gained multiple FDA approvals for both cosmetic and therapeutic indications.While the toxin injections have demonstrated a long history of safety, the drug remains highly controversial among regulators and legal entities.The following review provides a detailed, up-to-date description of botulinum toxin injection complications.Included topics are history, local and distal effects, long term safety, immunogenicity, use in pregnancy, and cosmetic use. Key Pointsa. Despite being one of the most studied pharmaceuticals and demonstrating a long history of safety, botulinum neurotoxin serotype A (BoNTA) remains to be a rather controversial drug and is under rigid scrutiny by the regulators and legal entities.b.Given that botulinum toxin injections have become the most frequent cosmetic procedure, providers must be familiar with the product and the data outlining its safety profile.

A previous pilot study demonstrated microfocused ultrasound with visualization (MFU-V) to lift and tighten the décolleté produced significant and durable aesthetic improvements. To further evaluate the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté in a larger patient population. Healthy women with moderate-to-severe décolleté skin lines and wrinkles were enrolled. After obtaining digital images, MFU-V was administered using 3 transducers emitting ultrasound at frequencies of 4 MHz and a focal depth of 4.5 mm, 7 MHz/3.0 mm, and 10 MHz/1.5 mm. During the procedure, 280 lines of discrete thermal coagulative points 25 mm long and 2 to 3 mm apart were applied to the treatment area. Additional imaging for masked assessments and live assessments were completed at 90 and 180 days. Among the evaluable subjects, 77 (66.4%) demonstrated aesthetic improvement at 180 days based on blinded assessments. Approximately, 75% and 65% of treated subjects demonstrated some degree of improvement at 90 and 180 days, respectively, and most were satisfied with treatment outcomes. Adverse events were generally mild. A single MFU-V treatment provided significant aesthetic improvement for moderate-to-severe décolleté lines and wrinkles for at least the 180-day duration of the study.