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.

A Silymarin Antioxidant Serum Improves Facial Acne Alone and as Part of a Treatment Regimen.

BACKGROUND: Silymarin is an antioxidant that can protect against free radicals that cause premature signs of aging and oil oxidation that may contribute to breakouts. AIMS: The objective of these studies was to evaluate a silymarin antioxidant serum alone and in combination with a prescription acne treatment regimen in improving facial appearance in blemish-prone skin.  Methods: Two international studies were conducted. A 12-week study in Brazil enrolled 56 subjects to examine the effect of silymarin antioxidant serum on facial acne. Clinical grading on acne lesions, skin tone, clarity, and postinflammatory hyperpigmentation (PIH) were conducted. In addition, consumer self-assessment, analysis for markers of lipid peroxidation, and sebumeter analysis were completed. Another Unites States (US)/German study enrolled 40 subjects who were on topical prescription acne medications to which silymarin antioxidant serum was added. Acne lesion counts, tolerability, and facial appearance assessments were conducted in this study. RESULTS: The Brazilian study demonstrated a 45% reduction in inflammatory lesions and a 43% reduction in noninflammatory lesions after 12 weeks of silymarin antioxidant serum use. In addition, sebumeter testing showed a 16% reduction in oiliness at week 1. The US/German study showed the benefits of the serum in persons already on prescription acne therapy by reducing facial erythema by 60%, dryness by 49%, and scaling by 67%. CONCLUSION: Silymarin is shown in clinical testing to have significant benefits in reducing lipid peroxidation, oiliness, and PIH, and in improving key markers of skin aging. Additionally, the serum can be used alone or as an adjunctive treatment in acne therapy to further benefit aging, acne-prone skin. J Drugs Dermatol. 2024;23(4):     doi:10.36849/JDD.8120.

International Consensus on Anti-Aging Dermocosmetics and Skin Care for Clinical Practice Using the RAND/UCLA Appropriateness Method.

BACKGROUND: The objective was to provide international recommendations on anti-aging dermocosmetics for clinical practice starting with essential ingredients for protection and repair before working up to advanced products for specific concerns.  Methods: Seven international experts reviewed 8 hypothetical case scenarios covering different ages, skin issues (eg, sensitivity, acne, melasma), and exposure to exposome factors for both sexes and all Fitzpatrick skin types (FST). The RAND/UCLA appropriateness method was used to obtain consensus. Seventeen key ingredients were rated on a scale from 1 (totally inappropriate) to 9 (totally appropriate). Statistical analysis, 2 meetings, and email discussions refined the recommendations. RESULTS: High-factor broad-spectrum sunscreen (ie, protects against ultraviolet [UV] A and B rays), niacinamide, and other topical antioxidants were recommended for all scenarios. Further discussions were required for other ingredients. Tinted sunscreen/iron oxide were recommended for all FST, although compliance may be sub-optimal for darker skin phototypes (IV-VI), if not cosmetically acceptable. Combining a facial foundation with broad-spectrum sunscreen was recommended for darker phototypes to obtain visible light protection closely matching diverse color tones. Retinols were not recommended as a first-line treatment for sensitive skin, especially FST V and VI, due to the risk of irritation. After ablative laser treatment, alpha hydroxy acids should be avoided or used with caution in FST IV to VI due to the risk of post-inflammatory hyperpigmentation. CONCLUSION: We describe a simple, practical tool for use in daily dermatology consultations for providing recommendations on anti-aging dermocosmetics to cover diverse and inclusive populations of patients, addressing all skin types and international needs.  J Drugs Dermatol. 2024;23(1):1337-1343.     doi:10.36849/JDD.7798.

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.

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.

Microinjections with hyaluronic acid in combination with glycerol: How do they influence biophysical viscoelastic skin properties?

BACKGROUND: Skin quality improvement with hyaluronic acid microinjections is increasing as a clinical treatment indication and as a scientific issue. This present study assessed changes in biomechanical viscoelastic skin properties after microinjections with the skin quality booster CPM-HA20G (Belotero Revive). MATERIALS AND METHODS: Fifteen subjects have been randomized in a 2:1 ratio to receive either three treatments (total 3 ml per side) or a single-dose treatment (total 1.5 ml per side) with CPM-HA20G at dermal level into the lower cheeks via microinjections. Treatments were provided 4 weeks apart. Biophysical measurements were performed describing the viscoelastic skin properties and the underlying skin structure. The measurements were performed before injection (week 0) and on follow-up visits 4, 8, 16, 24, and 36 weeks after the last injection treatment. RESULTS: One (p = 0.028) as well as three (p = 0.003) consecutive treatments with CPM-HA20G improved statistically significant skin firmness (R0). For the multiple-treatment group improved significant differences were observed for skin fatigue (R3; p = 0.007) and skin density (p = 0.017) with stable skin thickness levels (p > 0.05), too. There were zero-to-weak correlations between skin thickness and biomechanical skin properties (R0, rs  = 0.084; R3, rs  = 0.093). CONCLUSION: Overall, microinjections with CPM-HA20G improved biomechanical viscoelastic skin properties with a stronger and more pronounced effect in the multiple-treatment group. The observed changes may explain some of the skin quality improvements observed after treatment with CPM-HA20G.

Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an Open-Label Multicenter Clinical Study.

BACKGROUND: Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks. METHODS: A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting. RESULTS: Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P< 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity. CONCLUSION: CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months. J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737.

Safety of Cohesive Polydensified Matrix Cross-Linked Hyaluronic Acid Volumizing Gel in Temporal Hollows and Cheeks: A Prospective, Open-Label, Postmarket Study.

BACKGROUND: Facial aging is characterized by volume loss and progressive hollowing of temples and cheeks. Biodegradable filler materials are preferred over nonabsorbable materials; of these, hyaluronic acid (HA) fillers are the most often used because of their favorable effectiveness and safety profile. OBJECTIVE: To confirm the safety and effectiveness of Cohesive Polydensified Matrix (CPM)-HA26 gel in the treatment of volume deficiency. METHODS: Subjects received up to 2 treatments in the temples and/or cheeks. A blinded investigator assessed improvement according to the Merz Temple Volume Scale (MTVS) and Merz Cheek Fullness Assessment Scale (MCFAS). Subjects were followed for 48 weeks after the last treatment. RESULTS: In total, 87 healthy subjects were enrolled. The proportion of subjects achieving at least a 1-grade improvement on MTVS and/or MCFAS was above 70% for each (MTVS: Weeks 4, 24, and 48 = 95.4%, 94.2%, and 77.0%; MCFAS: Weeks 4, 24, and 48 = 92.3%, 83.1%, and 71.8%). Based on MTVS and MCFAS scores at Visit 5, improvement remained visible at up to 48 weeks. No treatment-related serious AEs occurred. CONCLUSION: CPM-HA26 demonstrated both a favorable safety and effectiveness profile, with improvement in facial volume evident for up to 48 weeks. It was well tolerated and had a positive, long-lasting effect.

Cell-Free Blood Cell Secretome (BCS) Counteracts Skin Aging and Restores Firmness and Elasticity.

BACKGROUND: Blood Cell Secretome, BCS (also Autologous Conditioned Serum, ACS) is efficacious in treatment of musculoskeletal disorders. It contains inflammation resolving cytokines, growth factors, exosomes, and lipid mediators. Skin aging is associated with reduced TGF-ß signaling and collagen synthesis and chronic (sub-acute) inflammation, among other factors. Pre-clinically, BCS counteracts these mechanisms, suggesting it as a treatment against cutaneous aging. OBJECTIVE: This 24-week study evaluated the effects of deep dermal to immediate sub-dermal micropuncture injections of cell-free BCS in patients with age-related reduced facial skin elasticity. METHODS: In this prospective, single-armed, mono-center study, 21 women underwent 4 BCS treatment sessions over 12 weeks with follow-up at 24 weeks. The primary endpoint was skin elasticity measured by cutometry. Secondary endpoints were safety, skin hydration, and aesthetic assessments using global aesthetic improvement scale. RESULTS: Skin firmness increased significantly between baseline and 12 weeks (P<0.001) and further increased by 24 weeks (P<0.001). Skin tiring was congruently reduced (P<0.001). Skin hydration and aesthetic ratings improved significantly. No BCS-related adverse reactions occurred. CONCLUSION: BCS treatment resulted in increased firmness and hydration, usually attributed to younger skin. BCS is potentially the first cell-free autologous therapy for skin rejuvenation derived from patients’ own blood. J Drugs Dermatol. 2021;20(6):682-688. doi:10.36849/JDD.5018.

IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines.

BACKGROUND: To further explore clinical trial results indicating increasing doses of botulinum toxin A prolong duration of effect, a 2-stage, phase 2, randomized, double-blind study investigated the duration of effect and safety of incobotulinumtoxinA (INCO; Xeomin®, Bocouture®) doses higher than the US Food and Drug Administration-approved 20 units (U) for glabellar frown lines (GFL). The stage 1 primary efficacy and safety results were reported previously. Here, we report the results of the final analysis (stage 1 and 2), including primary and secondary efficacy and safety endpoints. METHODS: A total of 241 subjects with moderate-to-severe GFL were randomized to receive a single treatment with 20 (N=61), 50 (N=60), 75 (N=61), or 100U (N=59) INCO. The primary efficacy endpoint was duration of ≥ 1-point improvement from baseline assessed by investigator at maximum frown on the Facial Wrinkle Scale. RESULTS: The median duration of effect was 175 days for the 20U group (95% CI 142, 185), 185 days for the 50U group (95% CI 182, 205), 210 days for the 75U group (95% CI 182, 217), and 215 days for the 100U group (95% CI 183, 237). The incidence of treatment-related adverse events was low across all doses and there were no treatment-related serious adverse events. CONCLUSIONS: These results demonstrate that all INCO doses were well tolerated, consistent with the known safety profile of 20U, and increasing dose prolongs the duration of effect for GFL. J Drugs Dermatol. 2021;20(10):1052-1060. doi:10.36849/JDD.6377THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines.

BACKGROUND: Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin®, Bocouture®; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here. METHODS: 151 subjects with moderate-to-severe GFL were randomized 1:2:2 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale. RESULTS: The median duration of effect was 185 days for the 50U dose group (95% CI:[182, 205]) and 210 days for the 75U dose group (95% CI:[182, 217]). Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P=0.4349). The incidence of treatment-related adverse events was low across all doses (20U:2[6.7%], 50U:6[10.0%] and 75U:8[13.1%]). CONCLUSIONS: These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL. J Drugs Dermatol. 2020;19(10):985-991. doi:10.36849/JDD.2020.5454.

Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.

BACKGROUND: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection. OBJECTIVES: The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance. METHODS: This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up. RESULTS: Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: "how rested your face looks" (P < 0.0001-0.0415), "I feel okay about myself" (P = 0.0011-0.0399), and "I feel attractive" (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigators' live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = -0.41 and r = -0.36 [both P < 0.0001], respectively). CONCLUSIONS: Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.

Liquid Formulation of AbobotulinumtoxinA: A 6-Month, Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of a Single Treatment, Ready-to-Use Toxin for Moderate-to-Severe Glabellar Lines.

BACKGROUND: Safety and efficacy of botulinum toxin A for glabellar line (GL) treatment are well established. Currently approved formulations require reconstitution before injection. OBJECTIVES: The authors sought to assess 6-month efficacy, safety, and patient satisfaction of new ready-to-use abobotulinumtoxinA solution for injection (ASI) in patients with moderate-to-severe GL at maximum frown. METHODS: The authors conducted a phase 3, double-blind, randomized, placebo-controlled trial (NCT02353871). Patients (N = 185) were randomized (2:1) to receive ASI 50 U or placebo. GL severity was evaluated at days 8, 15, 29, 57, 85, 113, 148, and 183 employing a 4-point scale for investigator's live assessment (ILA) and subject's self-assessment (SSA). Primary endpoint was ILA of GL at maximum frown at day 29, and secondary endpoints were ILA and SSA of GL at maximum frown (all time points), patient satisfaction with GL appearance, time to onset, and duration of action. RESULTS: Responder rates were significantly higher for ASI vs placebo (88.3% vs 1.4%; P < 0.0001) at day 29 by ILA and all time points by ILA (P < 0.0001-0.0441) and SSA (P < 0.0001-0.0036). Sixty percent of patients reported onset of treatment response on or before day 3 (P < 0.0001 vs placebo), and in 5% of patients, efficacy by ILA lasted 6 months (day 183; P = 0.0441 vs placebo). Patient satisfaction rates were significantly higher for ASI vs placebo at all visits (P < 0.0001). Safety was comparable with the known abobotulinumtoxinA profile. CONCLUSIONS: ASI was significantly efficacious for improving moderate or severe GL vs placebo by investigator and patient assessment. ASI was associated with high patient satisfaction, a long duration of action, and comparable safety profile to abobotulinumtoxinA.

Validated Assessment Scales for the Female Asian Calf.

BACKGROUND: Clinical photonumeric scales have been developed and validated to objectively measure the effectiveness of aesthetic treatments in specific anatomical areas; however, these are based on the typical features of Caucasian patients. No clinical scale for Asian calf appearance currently exists. OBJECTIVE: To develop and validate a calf assessment scale for use in the female Asian patient population. METHODS AND MATERIALS: During 2 validation sessions, 13 raters assessed calf images of female Asian subjects (N = 35) viewed from behind with feet flat on the floor (at rest) and on tiptoes (dynamic). Images were rated from 0 (very slim, linear profile) to 4 (very severe convex profile). RESULTS: Inter-rater and intra-rater reliability were "substantial" (≥0.6, intraclass correlation coefficient [ICC] and weighted kappa) for the calf-at rest, calf-dynamic, and calf summary score. Reliability was "substantial" for calf-at rest and calf-dynamic (≥0.6, ICC and weighted kappa) and "almost perfect" (0.85) for the calf summary score. BMI and calf circumference were highly correlated with scale ratings, and calf circumference was a significant predictor. CONCLUSION: This new photonumeric assessment scale has value for assessing the female Asian calf, providing a standardized measure of calf appearance in clinical practice and clinical research settings.

Validated Assessment Scales for Cellulite Dimples on the Buttocks and Thighs in Female Patients.

BACKGROUND: New treatment methods for cellulite require globally accepted scales for aesthetic research and patient evaluation. OBJECTIVE: To develop a set of grading scales for objective assessment of cellulite dimples on female buttocks and thighs and assess their reliability and validity. MATERIALS AND METHODS: Two photonumeric grading scales were created and validated for dimples in the buttocks in female patients: Cellulite Dimples-At Rest, and Cellulite Dimples-Dynamic. Sixteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS: Overall inter-rater reliability and intra-rater reliability were both "almost perfect" (≥0.81, intraclass correlation efficient and weighted kappa) for the At Rest scale. For the Dynamic scale, inter-rater reliability and intra-rater reliability were "substantial" (0.61-0.80). There was a high correlation between the cellulite scales and body mass index, age, weight, and skin laxity assessments. CONCLUSION: Consistent outcomes between raters and by individual raters at 2 time points confirm the reliability of the cellulite dimple grading scales for buttocks and thighs in female patients and suggest they will be a valuable tool for use in research and clinical practice.

Validated Assessment Scales for Skin Laxity on the Posterior Thighs, Buttocks, Anterior Thighs, and Knees in Female Patients.

BACKGROUND: The demand for noninvasive skin-tightening body procedures is increasing. OBJECTIVE: To develop a set of grading scales for the objective assessment of skin laxity and assess their reliability and validity. MATERIALS AND METHODS: Two photonumeric grading scales were created and validated for skin laxity in female patients: Skin Laxity-Posterior Thighs/Buttocks, and Anterior Thighs/Knees. Fifteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS: Overall inter-rater reliability according to intraclass correlation efficient (ICC) 2.1 and weighted kappa was at least "substantial" for both scales in both sessions, and "almost perfect" (≥0.81) for the Anterior Thighs and Knees scale in session 2. Intra-rater reliability was "almost perfect" for both scales (ICC 2.1) and "substantial" to "almost perfect" by weighted kappa. A correlation between the skin laxity scales and body mass index, age, weight, sun exposure, and cellulite severity was observed. CONCLUSION: The skin laxity photonumeric grading scales are valid and reliable instruments for assessing laxity on the posterior thighs and buttocks, and anterior thighs and knees. The scales will be of value for standardizing clinical evaluations and quantifying outcome measurements in research and clinical practice.

A Validated Assessment Scale for Asian Chin Projection.

BACKGROUND: As the number of different aesthetic treatments increase, numerous photonumeric assessment scales have been developed and validated to measure the effectiveness of these new treatments and techniques. Photonumeric rating scales have been developed to objectively assess improvements in anatomical areas; however, these have been based on the features of Caucasian patients. OBJECTIVE: To develop and validate a Chin Projection Scale for use in the female Asian patient population. METHODS AND MATERIALS: During 2 validation sessions, 13 raters assessed full frontal and lateral facial views of 50 Asian subjects and also estimated their age and the aesthetic treatment effort required for each subject. Chin projection was rated on a scale from 0 (optimal) to 4 (very severely receding). RESULTS: Inter-rater reliability was 0.80 (substantial) for Validation Session 1 and 0.83 (almost perfect) for Validation Session 2. The results for Estimated Age and Estimated Treatment Effort were essentially the same. CONCLUSION: This study demonstrated the validity of the first photonumeric assessment scale for assessing the appearance of the female Asian chin. This new scale will provide a standardized measure of chin projection for Asian patients in clinical practice and clinical research settings.

Validation of a Photonumeric Assessment Scale for Grading the Slope of the Asian Forehead.

BACKGROUND: As the number of aesthetic treatments has grown, so have the number of photonumeric assessment scales used to compare the effectiveness of these aesthetic treatments in specific anatomical areas; however, these are primarily based on Caucasian features. OBJECTIVE: To assess the validity of the first aesthetic scale for assessing the slope of the Asian forehead. A secondary objective was to correlate this scale with subject demographics and baseline characteristics. METHODS: During 2 validation sessions, 13 raters assessed full frontal and lateral facial images of female (n = 28; 56.0%) and male (n = 22; 44%) subjects. For each subject, the severity of forehead sloping was graded from 0 (convex forehead, optimal forehead volume) to 4 (concave forehead, very severe sloping). Raters also assessed the age of each subject and the estimated aesthetic treatment effort required to treat each subject. RESULTS: Inter-rater reliability was "substantial" with scores of 0.67 and 0.68 for the first and second validation sessions, indicating high reliability. BMI showed the highest correlation with the scale and was a significant predictor in the final regression model. CONCLUSION: This photonumeric assessment scale will be useful for assessing the slope of the Asian forehead in both clinical and research settings.

IncobotulinumtoxinA: A Highly Purified and Precisely Manufactured Botulinum Neurotoxin Type A

Aesthetic dermatologic applications of botulinum neurotoxin (BoNT), including treatment of glabellar lines, horizontal forehead lines, and crow's feet, were the most common non-surgical cosmetic procedures in the US in 2017, with high levels of subject satisfaction. Since the first BoNT type A (BoNT-A) formulation was approved in 1989, the number of formulations available on the world's commercial markets has increased and new approvals are expected. BoNT is produced by Clostridium botulinum in nature as part of a large protein complex. However, the unnecessary clostridial proteins, which dissociate from BoNT under physiological conditions with a half-life of <1 minute, have no role in clinical applications. Data demonstrate that BoNT administration can elicit an immunological response, leading to production of neutralizing antibodies that can be associated with reduced efficacy or treatment non-response. As repeat treatments are required to maintain efficacy, clinicians should be aware of the possibility of antibody development and choose a BoNT with the lowest risk of immunogenicity. IncobotulinumtoxinA is manufactured using advanced technology to precisely isolate the pure BoNT without unnecessary clostridial proteins, and with low immunogenicity and high specific activity. In incobotulinumtoxinA clinical studies, no previously BoNT-naïve subjects developed neutralizing antibodies, and there was no secondary non-response to incobotulinumtoxinA treatment. Here we review the role of unnecessary clostridial proteins in BoNT-A and discuss the unique incobotulinumtoxinA manufacturing and purification process with a focus on the implications for use in aesthetic medicine. J Drugs Dermatol. 2019;18(1):52-57.