Facial Wrinkle Scale Research Articles

NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials.

Botulinum neurotoxins used in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors. Evaluate the efficacy and safety of ready-to-use nivobotulinumtoxinA liquid formulation for the treatment of glabellar lines (GL) with/without treatment of lateral canthal lines (LCL). Two multicenter, phase 3, double-blind, randomized trials enrolled participants with moderate-to-severe GL (Study 001) or moderate-to-severe GL+LCL (Study 005). Participants received double-blind nivobotulinumtoxinA (20U) or placebo (Period 1) then ≤2 open-label nivobotulinumtoxinA GL treatments (Period 2) in Study 001 or double-blind nivobotulinumtoxinA 20U (GL), nivobotulinumtoxinA 44U (GL+LCL), or placebo (Period 1) then ≤2 double-blind injections of the same treatment (Period 2) in Study 005. The composite primary endpoint was the proportion of participants achieving ≥2-grade improvement in Facial Wrinkle Scale (FWS) at maximum frown on investigator and participant assessment; co-primary endpoints were investigator- and participant-assessed FWS "none or mild" rating. At Day 30, significantly higher responder rates were observed for the composite primary endpoint with GL treatment alone (Study 001, 46.1%; Study 005, 45.1%) and GL+LCL (Study 005, 41.3%) versus placebo (0%; all P < 0.001). Responder rates of "none or mild" by investigator and participant assessment, respectively, were significantly higher for GL treatment alone (Study 001, 77.2% and 65.0%; Study 005, 74.3% and 68.8%) and GL+LCL (Study 005, 74.0% and 61.2%) versus placebo (all P < 0.001). Adverse events were similar between treatment groups and placebo. Liquid nivobotulinumtoxinA was effective and well tolerated for treating moderate-to-severe GL alone or with LCL.

Comparative study between the efficacy of prabotulinum toxin-A versus onabotulinum toxin-A for the treatment of upper facial expression lines.

Botulinum Toxin (BoNTA) is the most used nonsurgical aesthetic procedure to treat facial expression lines. This study compared the efficacy of Prabotulinum toxin-A, a novel BoNTA that originates from Clostridium botulinum Hall-A, with onabotulinum toxin-A in treating facial expression lines using the Facial Wrinkle Scale (FWS) and FACE-Q questionnaires. This was an experimental, comparative, longitudinal, open-label, and prospective study. Patients aged between 25 and 40 years with upper-third facial expression lines were included. Follow-ups were made at three, seven, 30, and 120 days. A total of 26 patients were included: 20 female, and six males, with a mean age of 28.26 years. An average of 31.00 IU and 31.38 IU were administered to the onabotulinum and prabotulinum groups, respectively. The prabotulinum group demonstrated superiority in FWS and Face-Q scores between the first and third days (p ≤ 0.001, p < 0.001, respectively), which continued on day 7. By day 30, there were no differences in the scores of the two questionnaires. Prabotulinum toxin-A is a safe and effective treatment for upper-third facial wrinkles. On day three and seven, the results suggest that prabotulinum toxin-A has a quicker onset of action than onabotulinum toxin-A. On days 30 and 120, both groups showed similar FWS and Face-Q scores.

A prospective and randomized study comparing ultrasound-guided real time injection to conventional blind injection of botulinum neurotoxin for glabellar wrinkles.

Botulinum neurotoxin injections are the most frequently performed cosmetic procedures, but conventional blind injection for glabellar wrinkles remains to have some limitations. We intend to directly inject botulinum neurotoxin into the glabella complex guided by real time ultrasound. We aim to propose a more efficient and safer botulinum neurotoxin injection strategy for glabellar wrinkles. A total of 40 subjects with moderate to severe glabellar lines were enrolled in this study to receive botulinum neurotoxin injection, either through ultrasound-guided real time injection or conventional blind injection. Facial Wrinkle Scale (ranging from 0 = none to 3 = severe) and inter-brow distance (from 3D scanned face images) were used to evaluate the glabellar wrinkles improvement. Paired t test and two-sample t test were performed to analyze the within-group and between-group differences. The wrinkle score reduction was significant (p < 0.0001) immediately after the injection in ultrasound-guided injection group, but not in blind injection group (p = 0.163). Ultrasound-guided injection also showed a higher performance of wrinkle score reduction and more effective inter-brow distance increase over blind injection at Day 0 (p < 0.0001), Day 1 (p < 0.0001), Day 21 (p < 0.01) and Day 35 (p < 0.01) after initial treatment. The results of the study confirmed that botulinum neurotoxin injection for glabellar wrinkles under ultrasound guidance achieves quicker onset of action and better final outcomes compared to conventional blind injection.

Self-perception of natural outcome, appearance, and emotional well-being after OnabotulinumtoxinA treatment for upper facial lines: Post hoc analysis across age and gender.

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.

High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines.

OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL). To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL. A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction. OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days. A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.

Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines.

BackgroundOnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs.ObjectivesThe aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs.MethodsThis 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events.ResultsThe modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect.ConclusionsGL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.Level of Evidence: 2

Comparison of Effectiveness and Safety of a Botulinum Toxin Monotherapy and a Combination Therapy with Hyaluronic Acid Filler for Improving Glabellar Frown.

Among numerous cosmetic procedures for face rejuvenation performed all over the world, botulinum toxin type A (BoNT-A) for wrinkles is one of the most widely practiced procedures. However, for severe frowns, the application of botulinum toxin is often insufficient. In this study, the effects of hyaluronic acid filler combination therapy and the BoNT-A alone were evaluated. Forty subjects with 2 or higher points (moderate to severe) of a facial wrinkle scale (FWS) when frowning in the glabellar area were assigned to 2 group: Botulinum toxin type A monotherapy group and a combination regimen of the toxin and hyaluronic acid filler group. Subjects visited outpatient department every 4 weeks until 28 weeks after the injection, and the assessment of the efficacy using FWS, subject satisfaction at both resting and maximum frowning and safety analysis were performed. Subjects of both group was administered 18U of BoNT-A and the subjects of the combination group received additional 0.45mL of hyaluronic acid filler regimen. Both at rest and maximum frown, the combination group scored lower FWS than the toxin and showed significance in the week-20 and week-28. And at final visit, subject satisfaction score of the combination was higher than that of toxin group. For patients with moderate to severe glabellar frown, the combined administration of BoNT-A and hyaluronic acid filler could be a considerable treatment for improving wrinkles. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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

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&reg;, Bocouture&reg;) 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. 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 &ge; 1-point improvement from baseline assessed by investigator at maximum frown on the Facial Wrinkle Scale. 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. 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 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; Xeominr, Bocouturer) 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 g 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.

Efficacy, Patient-Reported Outcomes, and Safety in Male Subjects Treated With OnabotulinumtoxinA for Improvement of Moderate to Severe Horizontal Forehead Lines.

Men represent a growing segment of the facial aesthetic market. To evaluate investigator-assessed efficacy, patient-reported outcomes, and safety after onabotulinumtoxinA treatment of forehead lines (FHL) in men. Subjects with moderate to severe FHL received onabotulinumtoxinA (frontalis: 20 U; glabellar complex: 20 U, with/without 24 U in crow's feet regions) or placebo in 6-month, double-blind periods of 2 pivotal trials. Results for men were pooled. Men comprised 12% (140/1,178) of subjects. Day 30 male responder rates for achieving at least 1-grade Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150. Despite men having proportionately more severe FHL at baseline, 81.8% and 79.8% achieved Day 30 FWS ratings of none or mild at maximum eyebrow elevation and at rest, respectively (p < .05); significance versus placebo was maintained through Day 120. Men reported high satisfaction rates and improved psychological impacts. No new safety signals were detected. Standard dosing and administration of onabotulinumtoxinA significantly improved static and dynamic FHL appearance, despite men having proportionately more severe FHL at baseline. Men reported high satisfaction and appearance-related psychological impact improvements.

Safety and Efficacy of OnabotulinumtoxinA for Treatment of Crow's Feet Lines in Chinese Subjects.

This study evaluated the safety and efficacy of onabotulinumtoxinA for the treatment of crow's feet lines (CFL) in Chinese subjects. This 5-month, double-blind, randomized, parallel-group, placebo-controlled phase 3 study was conducted in China. Subjects with moderate-to-severe CFL at maximum smile received a single treatment of onabotulinumtoxinA 24 U (total; n = 316) or placebo (n = 101) on day 1. The primary efficacy measure was the proportion of investigator-assessed responders (achieved CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide at day 30). Additional endpoints included other response definitions (achieving at least 1-grade improvement at maximum smile and at rest using the Facial Wrinkle Scale with Asian Photonumeric Guide at day 30), duration of effect, subject-reported outcomes, and safety. All efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P < 0.001) in the onabotulinumtoxinA group (63.9%) versus the placebo group (5.0%). The proportion of subjects assessing the change in CFL appearance as much improved/very much improved was also significantly greater with onabotulinumtoxinA than placebo (P < 0.001). Subjects' self-assessed outcomes were similar to investigator-assessed results. Median duration of effect with onabotulinumtoxinA was ≥5 months using all responder definitions. A low occurrence of treatment-related adverse events was reported, with no new safety findings. OnabotulinumtoxinA 24 U was effective and well tolerated for the treatment of CFL in Chinese subjects, with responses maintained over 5 months.

Muscle Insertion and Strength of the Muscle Contraction as Guidelines to Enhance Duration of the Botulinum Toxin Effect in the Upper Face.

In this series of patients the cutaneous insertion and strength of voluntary contraction of the muscles in the upper third of the face were used as guidelines for botulinum toxin application named "BTA Codes." Anatomical dissection of fresh cadavers identified the shape and cutaneous insertions of the muscles in the upper third of the face. Patient voluntary contraction of the muscles in the upper third of the face created different patterns of skin lines classified by the 4-grade Facial Wrinkle Scale. For botulinum toxin application injections points followed the muscle cutaneous insertion and dose the 4-grade Facial Wrinkle Scale. Injection points ranged from 3 to 23 points per patient, average of 9.4 points. Dose per point varied from 2.5 to 7.5U, ranging from 12.5 to 72.5U per patient, average of 33.82U. Skin lines resulting from the voluntary contraction of the muscle prior to toxin application were stated as baseline 1. The absence of skin lines and muscle activity on day fifteen after toxin application defined baseline 2. Skin lines resulting from the recovered voluntary contraction of the muscle after toxin application like those of baseline 1 established baseline 3. The botulinum toxin effect was the time elapsed between baselines 2 and 3, ranging from 171 to 204days, average of 183.72days, greater than the 3 or 4 months reported in the literature. "BTA Codes" is a set of rules to apply botulinum toxin supported by muscle anatomy and degree of voluntary contraction to enhance the duration of its effect. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Forehead Line Treatment With OnabotulinumtoxinA in Subjects With Forehead and Glabellar Facial Rhytids: A Phase 3 Study

Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies. To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL). A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire. The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated. OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.

OnabotulinumtoxinA (Botox) in the Treatment of Crow\u2019s Feet Lines in Japanese Subjects

BackgroundThis study evaluated the safety and efficacy of onabotulinumtoxinA in Japanese subjects with crow’s feet lines (CFL).MethodsThis phase 3, multicenter, double-blind, randomized study included 2 treatment periods: 6-month placebo-controlled period followed by a 7-month open-label period. In period 1, subjects with moderate to severe CFL received onabotulinumtoxinA 24 U (n = 104) or 12 U (n = 99), or placebo (n = 97). In period 2, placebo subjects switched to onabotulinumtoxinA 24 U or 12 U (double-blind dose). Up to 5 total treatments were permitted for subjects meeting re-treatment criteria. The primary efficacy measure was the proportion of investigator-assessed responders (achieving CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide [FWS-A] at day 30 of treatment 1). Additional endpoints included other responders (achieving at least 1-grade improvement at maximum smile and at rest using the FWS-A at day 30), responders at other time points, duration of effect, subject-reported outcomes, and safety.ResultsAll efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P < 0.001) in the onabotulinumtoxinA 24 and 12 U groups (68.3 and 56.6%, respectively) compared with the placebo group (8.2%). Efficacy results were consistent over repeated treatments, and subjects’ self-assessed outcomes were similar to investigator-assessed results.ConclusionsTreatment with onabotulinumtoxinA 24 and 12 U improved the appearance of CFL in Japanese subjects and was well tolerated, with no new safety findings.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Percutaneous Myotomy With a Small Needle-Knife and Lipoinjection for Treatment of Glabellar Frown Lines

Glabellar frown lines are a common aesthetic concern, and minimally invasive techniques to treat frown lines have become popular. The authors developed a technique to minimize frown lines by means of percutaneous myotomy with a small needle-knife and lipoinjection. Sixty-nine patients underwent treatment of the glabellar frown lines in a prospective study. Percutaneous myotomy of the corrugator supercilii and procerus was conducted with a small needle-knife, and autologous fat was transferred to the glabellar region. Two independent investigators assessed improvement of the glabellar frown lines by applying the Merz Facial Wrinkle Scale preoperatively and 6 months postoperatively. Improvement by ≥1 point was regarded as a response to treatment. Patients also conducted a self-assessment based on the Global Aesthetic Improvement Scale. The mean follow-up period was 8 months. The evaluators determined that the glabellar frown lines of 62 patients (89.9%) responded to treatment. For 4 patients (5.8%), the frown lines were partially improved, and the frown lines did not improve for 3 patients (4.3%). In a self-assessment, 64 patients (92.8%) perceived improvement in their frown lines 6 months postoperatively. No serious complications were recorded. Treatment of glabellar frown lines by percutaneous myotomy with a small needle-knife and lipoinjection is reliable and minimally invasive. 4.

Different Glabellar Contraction Patterns in Chinese and Efficacy of Botulinum Toxin Type A for Treating Glabellar Lines: A Pilot Study.

Published research studies have described the existence of 5 glabellar contraction patterns. Botulinum toxin A (BoNTA) has been an approved and effective treatment of glabellar lines. To study the pattern and frequency of glabellar contraction patterns in the Chinese population. To compare injection patterns and doses of BoNTA in Westerners within China. Four hundred fifty-six healthy volunteers were randomly recruited. Photographs both in static and in frown state were taken and classified based on the method of 5 glabellar line patterns. The severity of the glabellar lines both at repose and during forced contraction was assessed by the Facial Wrinkle Scale (FWS). Subsequently, 75 of them were treated with BoNTA. The frequency of the various glabellar line patterns differs greatly between Chinese and Westerners with the "Converging arrows" pattern being the most common type and the "V" pattern being the least common when compared with the Westerners. Lower doses of BoNTA significantly improved the static and dynamic glabellar lines in the Chinese. The classification of 5 glabellar patterns is compatible for the Chinese population despite different proportions. The dosage of BoNTA should be less than 20 U during treatment in China with lowered incidence of complications.

Repeated OnabotulinumtoxinA Treatment of Glabellar Lines at Rest Over Three Treatment Cycles.

OnabotulinumtoxinA has demonstrated the ability to eliminate mild glabellar lines at rest; however, less is known regarding the effect of repeat treatment on more severe lines at rest. To assess the effect of repeated onabotulinumtoxinA treatment for reduction of glabellar lines at rest. Subjects 18 to 75 years old with at least mild glabellar lines at rest, as assessed by the validated Facial Wrinkle Scale (FWS) with photonumeric guide (score ≥ 1), received 3 treatments of 20 U onabotulinumtoxinA 4 months apart (N = 225). "Response" was defined as elimination of glabellar lines at rest (FWS score = 0) at any time point (Days 7, 30, 60, 90, and 120). Effect of treatment cycle on response was analyzed using repeated measures logistic regressions (p < .05). Most subjects were female (85%) and white (88%) (age range: 35-54 years). The likelihood of significant response was as follows: for all subjects combined (odds ratio [OR]: 1.31), for subjects with mild resting lines at baseline (OR: 1.49), and for older women (≥55 years) with mild resting lines at baseline (OR: 2.22). Of all subjects, 76% responded after 1 treatment, and 45% responded in all 3 cycles. Subjects repeatedly treated with onabotulinumtoxinA showed progressive improvement in glabellar lines at rest.

Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial.

Various onabotulinumtoxinA doses are effective in treating forehead lines (FHL), with a trend toward lower doses. To evaluate efficacy and safety of onabotulinumtoxinA dose-ranging treatment of FHL when the frontalis area and glabellar complex are treated together. Adults with moderate-to-severe FHL received onabotulinumtoxinA 40 U (FHL, 20 U; glabellar lines [GL], 20 U), 30 U (FHL, 10 U; GL, 20 U), or placebo. Response was assessed at weeks 1, 2, day 30, and monthly to day 180. Coprimary efficacy end points were investigator- and subject-assessed Facial Wrinkle Scale scores of none or mild (day 30). Patient-reported outcomes, onset/duration of effect, and adverse events (AEs) were evaluated. Responder rates (investigator/subject, respectively) were 40-U group, 91.2%/89.5%; 30-U group, 86.4%/81.4%; placebo, 1.7%/5.1%. OnabotulinumtoxinA resulted in significantly greater responder rates than placebo (p < .001). Adverse events were mild to moderate and similar between groups (most common AEs: nasopharyngitis [4.6%] and headache [4.0%]). Treatment of FHL with onabotulinumtoxinA 40 and 30 U (in frontalis and glabellar complex muscles) was tolerable, effective, and sustained. Both doses significantly reduced FHL severity; however, the 40-U dose demonstrated a trend toward greater sustained benefit and longer duration of effect versus the 30-U dose, with similar AE rates.

Subject satisfaction with onabotulinumtoxinA treatment of glabellar and lateral canthal lines using a new patient-reported outcome measure.

Patient satisfaction with treatment is an important outcome in facial aesthetic medicine. To evaluate subject satisfaction with onabotulinumtoxinA treatment of glabellar lines (GL) and crow's feet lines (CFL) using the validated Facial Line Satisfaction Questionnaire (FLSQ). In this randomized double-blind study, subjects with moderate/severe GL and CFL received onabotulinumtoxinA (20 U, GL; 24 U, CFL) or placebo. Over 120 days, the following were assessed: satisfaction, achievement of treatment expectations, satisfaction with duration of treatment (FLSQ), severity of GL and CFL (Facial Wrinkle Scale [FWS]), and aesthetic improvement (Global Aesthetic Improvement Scale). Satisfaction in the per-protocol population was significantly greater at Day 60 in the onabotulinumtoxinA group (n = 60) compared with placebo (n = 57) for GL (81.7% vs 0%; p < .001). Most subjects treated with onabotulinumtoxinA remained satisfied up to 120 days. Achievement of treatment expectations (86.7%; Day 60), satisfaction (81.7%; Day 60), and satisfaction with the duration of treatment (61.6%; Day 90) were significantly better with onabotulinumtoxinA than placebo (p < .001) for GL and CFL combined. Efficacy (FWS) and aesthetic improvement were observed in most subjects at Days 30 and 60, respectively. High satisfaction rates are achieved and sustained in subjects treated with onabotulinumtoxinA for GL and CFL combined.

Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial.

This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, and safety/adverse events (AEs) were evaluated. All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations. Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.