Novel, Validated, 5-Point Photonumeric Scales for Assessment of the Perioral Region.

BACKGROUND: The use of validated scales is still considered the gold standard for evaluating the severity of an aesthetic facial condition. OBJECTIVES: The aim of this investigation was to create and validate 5-point photonumeric scales for the assessment of perioral lines and marionette lines. METHODS: A medical team created 2 different novel 5-point photonumeric scales for the assessment of perioral lines and marionette lines. Eleven international raters were involved in the digital validation, and 4 raters performed a live validation. RESULTS: For the Croma Static Perioral Lines-Assessment Scale, the digital interrater intraclass correlation coefficients (ICCs) were 0.88 (95% CI, 0.85-0.91) in the first rating and 0.87 (95% CI, 0.83-0.90) in the second rating. The digital intrarater ICCs were 0.90 (95% CI, 0.87-0.92). In the live rating, the interrater ICCs were 0.89 (95% CI, 0.85-0.93) in the first rating and 0.91 (95% CI, 0.87-0.93) in the second rating with an intrarater ICC of 0.91 (95% CI, 0.88-0.95). For the Croma Marionette Lines-Assessment Scale, the digital rating interrater ICCs were 0.85 (95% CI, 0.81-0.89) in the first rating and 0.87 (95% CI, 0.84-0.90) in the second rating with an intrarater ICC of 0.89 (95% CI, 0.88-0.91). In the live rating, the interrater ICCs were 0.73 (95% CI, 0.54-0.83) in the first rating and 0.79 (95% CI, 0.65-0.87) in the second rating with an intrarater ICC of 0.88 (95% CI, 0.83-0.94). CONCLUSIONS: The Croma Static Perioral Lines-Assessment Scale and the Croma Marionette Lines-Assessment Scale have exceptional inter- and intrarater agreements that justify their use in clinical and study settings for all ethnic groups.

Novel, Validated 5-Point Photonumeric Scales for Assessment of the Neck and Décolleté.

BACKGROUND: There is a scarcity of scales that assess platysmal bands, wrinkles in the décolleté, and horizontal neck lines in the digital and live setting. OBJECTIVES: The objective of this investigation was to create and validate 5-point photonumeric scales that assess horizontal neck lines, platysmal bands, and wrinkles in the décolleté. METHODS: A medical team created 3 different novel 5-point photonumeric scales for the assessment of horizontal neck lines, platysmal bands, and décolleté wrinkling. Eleven international raters were involved in the digital validation, and 4 raters performed a live validation. RESULTS: The Croma (Leobendorf, Austria) Horizontal Neck Lines Assessment Scale showed substantial interrater agreement and almost perfect intrarater agreement in the digital and live validations, respectively. The Croma Platysmal Bands Assessment Scale showed substantial intrarater agreement in both digital and live validations. For the décolleté, a static scale and a dynamic scale were created and validated. The Croma Static Décolleté Wrinkles Assessment Scale showed substantial and almost perfect interrater agreement in the digital and live validations, respectively, and the intrarater agreement in both was almost perfect. The Croma Dynamic Décolleté Wrinkles Assessment Scale showed almost perfect agreement in both validation settings for both interrater and intrarater measures. CONCLUSIONS: The Croma Horizontal Neck Lines Assessment Scale and the Croma Static and Dynamic Décolleté Wrinkles Assessment Scales have sufficient interrater and intrarater agreement for justifiable use in clinical and research settings.

Efficacy and Safety of Letibotulinumtoxin A in the Treatment of Glabellar Lines: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study.

BACKGROUND: Letibotulinumtoxin A (Hugel, Inc., Chuncheon, Republic of Korea and CROMA Pharma, Leobendorf, Austria) is a newly manufactured neurotoxin derived from Clostridium botulinum strain CBFC26. OBJECTIVES: The aim of this study was to assess the efficacy and safety of letibotulinumtoxin A in reducing glabellar line severity (GLS) and to evaluate long-term safety and efficacy following repeated injections. METHODS: In this prospective, randomized, parallel-group, double-blind, multicentre, placebo-controlled Phase III clinical trial, 355 subjects with moderate to severe glabella frown lines received injections of 20 U of letibotulinumtoxin A or placebo. GLS, onset and duration of effect, time to retreatment, and adverse events were evaluated. Response to treatment was defined as a GLS score of 0 or 1 (assessed by the subject and the investigator) and an improvement at Week 4 of ≥2 points in GLS score relative to baseline. RESULTS: At 4 weeks, 78.6% of the active treatment subjects were responders based on the investigator's assessment and 68.8% based on the subject's assessment, resulting in a composite responder rate of 64.7% for the active treatment group, whereas the corresponding rate was 0.0% in the placebo group (P < 0.001). Subjects noted a substantial improvement in GL severity as early as Day 2, with the median time to onset of effect being 3 days. The mean [standard deviation] time until first retreatment for the letibotulinumtoxin A group was 127.26 [65.6] days. Letibotulinumtoxin A was well tolerated. CONCLUSIONS: Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines.

Novel Validated Five-point Photonumeric Scales for Assessment of Static and Dynamic Forehead Lines.

Background: The objective of this investigation was to create and validate five-point photonumeric scales which assess static and dynamic forehead lines. Methods: Two different novel five-point photonumeric scales for the assessment of static and dynamic forehead lines were developed. Moreover, a photoguide was created, including subjects from both sexes, all age groups, and different Fitzpatrick skin types. A total of 11 raters from all over the world were involved in the digital validation, whereas four raters performed a live validation. Results: The Croma Static Forehead Lines-Assessment Scale showed almost perfect inter and intra-rater agreement in both the digital and the live setting with inter-rater intraclass correlation coefficients of 0.86 [95% confidence interval (CI): 0.82-0.89] in the first digital rating and 0.82 [95% CI: 0.78-0.86] in the second digital rating. The Croma Dynamic Forehead Lines-Assessment Scale showed almost perfect inter and intra-rater agreement in the digital setting with inter-rater intraclass correlation coefficients of 0.83 [95% CI: 0.79-0.86] in the first digital rating and 0.80 [95% CI: 0.75-0.84] in the second rating and almost substantial agreement in the live setting. Conclusions: The Croma Static Forehead Lines-Assessment Scale and the Croma Dynamic Forehead Lines-Assessment Scale have excellent inter and intra-rater agreements to be justifiably used in the clinical and study setting, both digitally and live across ethnic groups.

Longevity and subject-reported satisfaction after minimally invasive jawline contouring.

BACKGROUND: Minimally invasive treatments as soft tissue filler injections can enhance the appearance of the jawline. This prospective, single-center study investigated aesthetic outcome, patient satisfaction, adverse events, and volume changes after jawline contouring using standardized reporting scales and objectifiable 3D surface analysis. METHODS: A total of 30 patients (1 male and 29 females, mean age: 57.2 (±8.7) years) were investigated. Patients underwent jawline augmentation using a highly cross-linked hyaluronic acid-based soft tissue filler. Three-dimensional surface imaging was performed after 2 weeks, and 3, 6, 9, and 12 months. Furthermore, the aesthetic results and the occurrence of complications were investigated after two weeks, and 3, 6, 9, and 12 months. RESULTS: The surface-volume coefficient (SVC) had an average of 1.10 ± 0.2 after 14 days, 0.95 ± 0.1 after 3 months, 0.83 ± 0.1 after 6 months, 0.74 ± 0.1 after 9 months, and 0.63 ± 0.1 after 12 months. A significant correlation was revealed between time of measurement and measured SVC with rp  = -0.761, p < 0.001. Multivariate analysis revealed a significant difference between the measured SVC and the different time points of measurement with p < 0.001. The data revealed strong aesthetic improvement with results most often reported as "very much improved" according to the 5-point GAIS after 3, 6, and 9 months, both by the investigator and by the patients. A 12-month follow-up analysis showed "much improved" results in a majority of cases. CONCLUSION: The result of this investigation showed that jawline enhancement using minimally invasive soft tissue filler injections produces durable, safe results that are generally rated as very satisfying from a patient's and investigator's perspective over a time period of 12 months.

A prospective open-label, multicentre study evaluating a non-cross-linked hyaluronic acid based soft-tissue filler in the correction of lateral canthal and perioral lines.

OBJECTIVE: The aim of this investigation was to assess the effectiveness of a non-cross-linked hyaluronic acid based soft-tissue filler in the correction of lateral canthal lines and periorbital lines. MATERIAL AND METHODS: A total of 59 female Caucasian patients with a mean age of 52.6 ± 9.0 years were enrolled in this prospective open-label, multicentre study and received intradermal injections of a soft-tissue filler at baseline, after 3 and 6 weeks. Aesthetic improvement and patient satisfaction, skin hydration, skin firmness and skin elasticity, as well as adverse events were assessed at 3, 6, 8, 12 and 16 weeks. RESULTS: At baseline, the lateral canthal skin firmness was 0.206 ± 0.07 mm and increased after 8 weeks to 0.087 ± 0.08 mm with p < 0.001, while the perioral skin firmness was 0.205 ± 0.09 mm and increased after 8 weeks to 0.116 ± 0.08 mm with p < 0.001. Increases in skin hydration were observed after 8 weeks in both areas, however, did not reach statistical significance at any point. At week 8, 12 and 16 a majority (93.1%, 91.1% and 73.7% respectively) of the patients stated that they were 'satisfied' or 'very satisfied' with the treatment. CONCLUSION: Overall, the skin firmness and skin visco-elasticity showed significant increases in the lateral canthal and perioral region. Moreover, albeit not statistically significant, skin hydration increased in both areas after 8 weeks. The procedure has been shown to be safe and satisfactory for the treated patients; however, emergence of oral herpes should be added to the safety profile of intradermally applied hyaluronic acid treatments.

An open-label, 4-week, prospective clinical study evaluating the efficacy and safety of a novel targeted skin care line addressing five common skin conditions.

BACKGROUND: Common skin conditions, such as irritated, dry, aging, and oily skin or dark eye circles with periorbital edema, usually do not require pharmaceutical therapy in form of dermatological drugs. They can, however, still affect the quality of life significantly. With the advent of newer cosmetics, a more targeted treatment of these dermatological conditions has become available to the public. There are few clinical studies investigating the efficacy and safety of cosmetics, leaving consumers exposed to potentially false claims of the cosmetic industry. This study aims to assess the efficacy and safety of a novel skin care series addressing the aforementioned five common skin conditions. METHODS: This open-label, single-center, 4-week, prospective clinical study evaluated the efficacy and safety of five novel skin care formulations, each targeting one of five common skin issues in 176 study subjects. The primary endpoint parameters for the change in irritated skin, dark and puffy eyes, dry skin, aging skin, and oily skin were assessed through validated questionnaires, scales, and biomedical devices. RESULTS: After 4 weeks of topical application of each formulation of a new targeted skin care, a significant improvement in all primary endpoints was detected. No undesirable effects occurred during this study. CONCLUSION: This study showed a significant improvement in five common dermatological conditions with a novel targeted skin care series. Moreover, this study leads the way for an overdue critical assessment and certification of cosmetic product claims.

Validated 5-point photonumeric scales for the assessment of the jowls and chin.

OBJECTIVE: The objective of this investigation was to create and to examine the reproducibility and validity of 5-point photonumeric assessment scales that allow objective assessment of chin retrusion and jawline sagging using a digital and a live validation. MATERIAL AND METHODS: Two new 5-point photonumeric scales created to assess chin projection and jawline sagging were validated by 12 experts in a digital validation and by 5 experts in a live validation setting. Intra-rater agreement and inter-rater agreement were assessed. RESULTS: For the digital validation, an almost perfect intra-rater (Kappa: 0.89 [95% CI: 0.86-0.91]) and almost perfect inter-rater agreement in both sessions (Kappa: 0.80 [95% CI: 0.74-0.86] and 0.80 [95% CI: 0.74-0.86]) was achieved for the Croma Chin Projection Assessment Scale, while intra-rater agreement (Kappa: 0.88 [95% CI: 0.85-0.91]) was almost perfect for the Croma Jawline Sagging Assessment Scale and inter-rater agreement being substantial in the first session (Kappa: 0.76 [95% CI: 0.71-0.81]) and almost perfect in the second session (Kappa: 0.81 [95%CI: 0.76-0.85]). For the live validation, intra-rater agreement was almost perfect for the Croma Chin Projection Assessment Scale (Kappa: 0.82 [95%CI: 0.74-0.90]) and the Croma Jawline Sagging Assessment Scale (Kappa: 0.83 [95%CI: 0.77-0.89]), while inter-rater agreement was substantial in both sessions for both scales. CONCLUSION: The created chin and jawline photonumeric grading scales are valid and reliable tools for assessing chin projection and jawline sagging. The scales will be of value for standardized chin evaluation and quantifying outcomes in clinical research and daily practice.

Validated 5-point photonumeric scales for the assessment of the periorbital region.

OBJECTIVE: The objective of this investigation was to create and validate 5-point photonumeric scales for the assessment of dynamic crow's feet, static crow's feet, and infraorbital hollows. MATERIAL AND METHODS: Three novel 5-point photonumeric scales were created by a medical team. A total of 12 raters from all over the world performed a digital validation, and a total of 5 raters a live validation of the created scale. RESULTS: The statistical analysis revealed almost perfect intra-rater and inter-rater reliability in the digital validation of the scales for the assessment of static and dynamic crow's feet as well as infraorbital hollows. In the live validation, both crow's feet scales showed almost perfect intra-rater reliability, while the Croma Infraorbital Hollow Assessment Scale showed substantial intra-rater reliability. Inter-rater reliability was substantial for all three scales in the live validation. All three scales, the Croma Dynamic Crow's Feet Assessment Scale, Croma Static Crow's Feet Assessment Scale, and Croma Infraorbital Hollow Assessment Scale, were validated digitally and in a live setting. CONCLUSION: The created scales to assess infraorbital hollowing, dynamic and static crow's feet have been shown to provide substantial to almost perfect agreement in the digital and live validation and can thus be considered as helpful tools in the clinical and research setting. While technical methods and appliances to assess the degrees of severity of age-dependent features are advancing, validated scales are of great importance due to their ease of use and, as shown by the validations, reliability, and reproducibility.

Validated 5 - Point photonumeric scales for the assessment of hand atrophy.

OBJECTIVE: Quantifying the degree of dorsal hand atrophy is a challenging endeavor, but often necessary, in both the clinical and the research setting. The aim of this investigation was to create and consecutively validate a 5-point photonumeric scale for assessment of dorsal hand atrophy. MATERIAL AND METHODS: A medical team created a novel 5-point photonumeric scale. Twelve international raters were involved in the digital validation, while five raters performed a live validation. RESULTS: For the digital validation of the Croma Hand Atrophy Assessment Scale, a total of 72 subjects (58 females, 14 males) with a mean age of 43.0 ± 14.4 years [18-73 years] were assessed. For the live validation, 88 subjects (73 females, 15 males) with a mean age of 45.0 ± 14.1 years [20-73 years] were rated. The results revealed almost perfect intra-rater (ICC: 0.90 [95% CI: 0.88-0.92]) and inter-rater agreements (ICC: 0.85 [95% CI: 0.81-0.89] and 0.86 [95% CI:0.82-0.89]) in the digital validation and substantial intra-rater (ICC: 0.79 [95% CI: 0.75-0.82]) and inter-rater agreements (ICC: 0.75 [95% CI: 0.68-0.81] and ICC: 0.67 [95% CI: 0.54-0.77]) in the live validation. CONCLUSION: The created scale to assess dorsal hand atrophy has been shown to provide substantial-to-almost perfect agreement in the digital and live validation cycles and reached comparable intra-rater and inter-rater agreement to already published and validated scales. It is expected that the created scale will help physicians and researchers in the assessment of hand atrophy in the clinical and research setting in the future.

Volumization of the young and the old temple using a highly cross-linked HA filler.

BACKGROUND: A plethora of age-related changes contribute to hollowing of the temples, as bone remodeling, atrophy of the temporalis muscle, thinning of the skin, and deflation of the subcutaneous and deep temporal fat create the appearance of a skeletonized face. In addition, previous studies have established a relationship between facial skeletonization, temporal hollowing, and postmenopausal sarcopenia. OBJECTIVE: To compare the volume change, adverse events, and patient satisfaction of soft-tissue filler injections in the temple between young (<51) and old (>51) females. MATERIAL AND METHODS: A total of 30 women with a mean age of 53.1 ± 12.1 years underwent bilateral temporal volumization. Adverse events and satisfaction were assessed after 3 and 6 months. 3-Dimensional surface imaging was performed at baseline and after 2 weeks, 3 and 6 months to assess volumetric changes. RESULTS: A mean volume of 5.55 ± 1.9 cc was injected into the temples. A total of 31 adverse events were observed in 13 patients. The overall satisfaction of the procedure was very high after 3 and 6 months in both patient groups, and raters showed a significant agreement in their assessment of the aesthetic improvement, while the self-reported patient satisfaction was also substantially high. The surface-volume coefficient differed significantly between 14 days and 3 months post-injection only in pre-menopausal patients, while no significant difference was detected between 3 and 6 months. CONCLUSION: Temporal soft-tissue filler injections are safe and provide long-lasting aesthetic improvement both in pre- and postmenopausal women.