A Prospective, Multicenter, Evaluator-Blinded, Randomized Study of Diluted Calcium Hydroxylapatite to Treat Decollete Wrinkles.

BACKGROUND: Calcium hydroxylapatite (CaHA) dermal filler is used for a variety of aesthetic treatments; however, the safety and effectiveness of diluted CaHA for the treatment of décolleté wrinkles have not been established. OBJECTIVE: To demonstrate the effectiveness and safety of diluted CaHA (Radiesse; 1:2 CaHA:saline) injection for the improvement of décolleté wrinkles in females. METHODS: Eligible females with moderate or severe ratings on the Merz Aesthetic Scale (MAS) Decollete Wrinkles - At Rest received up to 3 injection cycles of diluted CaHA either 8 weeks apart (3 injection cycles) or 16 weeks apart (2 injection cycles). Effectiveness was evaluated by improvement on the MAS. Adverse events were recorded over a 52 week period. RESULTS: Sixteen weeks after the last treatment, the response rate (1-point improvement or greater) on the MAS Decollete Wrinkles - At Rest was 73.5% (P<0.0001; pooled sample) for all patients. The use of diluted CaHA in the decollete also demonstrated a favorable safety profile. CONCLUSIONS: Diluted CaHA is a safe and effective treatment for the improvement of decollete wrinkles in females.J Drugs Dermatol. 2024;23(7):551-556.  doi:10.36849/JDD.8261.

Five-year retrospective review of safety, injected volumes, and longevity of the hyaluronic acid Belotero Basic for facial treatments in 317 patients.

BACKGROUND: Hyaluronic acids (HA) fillers abound in the European community, many with different names in different countries. One such HA is Belotero Basic, recently approved by the FDA in the United States. OBJECTIVE: The objective of this article is to report on use of this HA in a German clinic, over a period of 5+ years, in 317 patients (668 treatments). METHODS AND MATERIALS: Authors retrospectively examined patient charts of 317 patients (312 females), aged 24 to 87 years. Chart review showed areas treated, range of volumes per area, and mean volumes. Patient satisfaction data was collected anecdotally over the five years. RESULTS: Volumes of the HA injected ranged from 0.2 mL to 3.0 mL, depending on the area being treated. No serious adverse events were noted in the chart review, nor was any Tyndall effect observed in the treated areas. Anecdotal information suggests high patient satisfaction with results, based on the return of these patients to the clinic for other treatments over the more than five years. CONCLUSION: Belotero Basic provides aesthetically pleasing results for treatment of facial defects, without carrying a risk of serious adverse events. North American physicians now have a new HA to consider as part of their treatment protocols.

Assessing Trustworthy AI in Times of COVID-19: Deep Learning for Predicting a Multiregional Score Conveying the Degree of Lung Compromise in COVID-19 Patients.

This article's main contributions are twofold: 1) to demonstrate how to apply the general European Union's High-Level Expert Group's (EU HLEG) guidelines for trustworthy AI in practice for the domain of healthcare and 2) to investigate the research question of what does "trustworthy AI" mean at the time of the COVID-19 pandemic. To this end, we present the results of a post-hoc self-assessment to evaluate the trustworthiness of an AI system for predicting a multiregional score conveying the degree of lung compromise in COVID-19 patients, developed and verified by an interdisciplinary team with members from academia, public hospitals, and industry in time of pandemic. The AI system aims to help radiologists to estimate and communicate the severity of damage in a patient's lung from Chest X-rays. It has been experimentally deployed in the radiology department of the ASST Spedali Civili clinic in Brescia, Italy, since December 2020 during pandemic time. The methodology we have applied for our post-hoc assessment, called Z-Inspection®, uses sociotechnical scenarios to identify ethical, technical, and domain-specific issues in the use of the AI system in the context of the pandemic.

Facial Skin Revitalization with Cohesive Polydensified Matrix-HA20G: Results from a Randomized Multicenter Clinical Study.

BACKGROUND: There is a growing interest in the application of hyaluronic acid (HA) derivatives in skin quality improvement. The aim of this study was to confirm safety and effectiveness of cohesive polydensified matrix-hyaluronic acid + glycerol (CPM-HA20G; Belotero Revive) in revitalization of early-onset photodamaged facial skin. METHODS: A total of 159 subjects with early signs of facial photodamaged skin were randomized in a 2:1 ratio to multiple- or single-dose treatment with CPMHA20G. Effectiveness assessments included biophysical measurements of skin hydration; elasticity, firmness, and roughness; investigator- and subject-assessed Global Aesthetic Improvement Scales; and FACE-Q Skin Changes and Treatment Satisfaction questionnaires. RESULTS: In both treatment groups, skin hydration improved from baseline to all follow-up visits in subjects with dry or very dry skin. This improvement was significant at week 16 after initial treatment in the multiple-dose group (P = 0.0013). Investigator- and subject-reported outcomes showed that the majority of subjects across all skin hydration types benefited from treatment, with higher satisfaction rates observed in the multiple-dose group. According to investigator-assessed Global Aesthetic Improvement Scale, 90.7% of subjects at week 12 in the multiple-dose and 74.6% of subjects at week 4 in the single-dose group were rated as at least "improved." All related treatment-emergent adverse events were transient, expected injection-site reactions of mild to moderate intensity. CONCLUSIONS: Effectiveness of CPM-HA20G for skin hydration in subjects with dry or very dry skin was demonstrated up to 9 months after last injection. Overall, CPM-HA20G demonstrated effective and safe use in facial skin revitalization among subjects with early-onset photodamaged skin.

Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study.

Cohesive polydensified matrix (CPM®) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM® fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM® fillers. Performance was assessed using the Merz Aesthetics Scales® (MAS). Pain was rated on an 11-point visual analog scale. Patients' and physicians' satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM® fillers with lidocaine are safe and effective for a wide range of esthetic facial indications.

Introduction of the Microdroplet Technique with Incobotulinumtoxin A for the Treatment of Crow's Feet.

To investigate the efficacy and safety of the addition of the microdroplet technique to conventional injections for the treatment of crow's feet with incobotulinumtoxin A, four women with moderate-to-severe crow's feet at maximum expression received three standard intradermal injections of incobotulinumtoxin A on both sides of the face (4U [0.1mL] at each injection point) plus six microdroplet injections of incobotulinumtoxin A (0.5U [0.025mL] per point) into the lateral canthal area on the left side of the face and an equal quantity of saline at the same injection points on the right side of the face. Investigators and subjects independently evaluated the degree of rhytide improvement both at rest and maximum expression after 28 and 84 days. Investigator and subject ratings for wrinkle severity at maximum expression were improved to a greater degree on the side of the face treated with additional microdroplet incobotulinumtoxin A in all subjects, except one who was over 65 years old. All women preferred the results on the left side of their face. Treatment was well tolerated. The addition of the microdroplet technique to standard practice for injecting incobotulinumtoxin A is a promising procedure for the treatment of crow's feet in women with moderate-to-severe wrinkles.

Treatment of the ageing hand with dermal fillers.

Following the trend in facial cosmetic procedures, patients are now increasingly requesting hand rejuvenation treatments. Intrinsic ageing of the hands is characterized by loss of dermal elasticity and atrophy of the subcutaneous tissue. Thus, veins, tendons and bony structures become apparent. Among the available procedures, intrinsic ageing of the hands is best improved by restoring the volume of soft tissue. Volume restoration can be achieved with a number of long-lasting dermal fillers with varying degrees of improvement and treatment longevity. The dermal fillers used in hand rejuvenation include autologous fat, collagen, hyaluronic acid, calcium hydroxylapatite and poly-L-lactic acid. Here, we describe our preferred injection method for hand rejuvenation using calcium hydroxylapatite and a single-bolus injection.

Botulinum toxin type A treatment to the upper face: retrospective analysis of daily practice.

BACKGROUND: Botulinum toxin type A treatment has been used for over 20 years to enhance the appearance of the face. There are several commercially available botulinum toxin type A products used in aesthetic clinical practice. The aim of this retrospective analysis was to compare the clinical efficacy of the most commonly used botulinum toxin type A preparations in daily practice. METHODS: Physicians from 21 centers in Germany completed questionnaires based on an inspection of subject files for subjects 18 years of age or over who had received at least two, but not more than three, consecutive treatments with incobotulinumtoxinA, onabotulinumtoxinA, or abobotulinumtoxinA within a 12-month period in the previous 2 years. Data on subject and physician satisfaction, treatment intervals, dosages, and safety were collected from 1256 subjects. RESULTS: There were no statistically significant differences between incobotulinumtoxinA and onabotulinumtoxinA with respect to physician and subject satisfaction, dosages, and adverse effects experienced. Both botulinum toxin type A preparations were well tolerated and effective in the treatment of upper facial lines. Due to low treatment numbers, abobotulinumtoxinA was not included in the statistical analysis. CONCLUSION: The results of this retrospective analysis confirm the results of prospective clinical trials by demonstrating that, in daily practice, incobotulinumtoxinA and onabotulinumtoxinA are used at a 1:1 dose ratio and display comparable efficacy and safety.

A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines.

OBJECTIVE: To investigate the efficacy and safety of incobotulinumtoxinA (also known as botulinum toxin type A [150 kDa], free from complexing proteins, or previously as NT 201), for the treatment of glabellar frown lines, in a prospective, open-label, multicenter, Phase III trial. DESIGN: The study was a prospective, open-label, multicenter, international, Phase III clinical study. Subjects with moderate-to-severe glabellar frown lines at maximum frown, as assessed by the investigator according to the facial wrinkle scale, were given one intramuscular treatment of 20U incobotulinumtoxinA, administered as 0. 1mL to each of five injection sites, and assessed over 84 days. Missing values were imputed using the baseline value or next observation carried backwards. Adverse events were documented for the duration of the study. SETTINGS: Two centers in Russia and one center in Germany. PARTICIPANTS: A total of 105 subjects (18-65 years) with moderate-to-severe glabellar frown lines at maximum frown were enrolled. MEASUREMENT: The primary endpoint was the percentage of responders at maximum frown (improvement of ≥1 on the facial wrinkle scale when compared with Day 0) on Day 28, as assessed by the investigator. RESULTS: Response to treatment with incobotulinumtoxinA with respect to the facial wrinkle scale at maximum frown on Day 28 and Day 84 was 98.1 and 80.0 percent, respectively (missing values imputed). At rest, 94.3 percent (imputed values) of subjects were responders on Day 28 while 81.9 percent were responders on Day 84 (imputed values). Consistent with assessment by the investigators, subjects also rated treatment success highly. Incidence of treatment-related adverse events was low and no patients developed neutralizing antibodies. CONCLUSION: IncobotulinumtoxinA is effective in the treatment of glabellar frown lines and is well tolerated.