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1.
Aesthet Surg J ; 42(11): 1318-1327, 2022 10 13.
Article in English | MEDLINE | ID: mdl-35704394

ABSTRACT

BACKGROUND: OnabotulinumtoxinA 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. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: GL 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.


Subject(s)
Botulinum Toxins, Type A , Neuromuscular Agents , Skin Aging , Double-Blind Method , Female , Forehead , Humans , Middle Aged , Patient Satisfaction , Personal Satisfaction , Treatment Outcome
2.
Dermatol Surg ; 46(4): 483-490, 2020 04.
Article in English | MEDLINE | ID: mdl-31517663

ABSTRACT

BACKGROUND: OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects. OBJECTIVE: To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese subjects. METHODS: This 13-month, double-blind, Phase 3 study randomized subjects to onabotulinumtoxinA 44 U (n = 48) or 32 U (n = 53) for CFL and GL for up to 5 treatments (CFL: 24 U or 12 U; GL: 20 U). Outcomes included proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety. RESULTS: Most subjects were responders (none/mild on FWS-A; CFL: 89.6% [44 U], 84.9% [32 U]; GL: 93.8% [44 U], 98.1% [32 U]) on Day 30. Across treatment groups, responder rates were consistent over time and treatments. Most subjects were satisfied with improved CFL appearance and with treatment. Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar. All TEAEs but one (peritonitis) were mild or moderate. CONCLUSION: Repeated onabotulinumtoxinA was effective and well tolerated.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Cosmetic Techniques/adverse effects , Neuromuscular Agents/administration & dosage , Patient Satisfaction , Skin Aging/drug effects , Adult , Botulinum Toxins, Type A/adverse effects , Double-Blind Method , Eye , Female , Forehead , Humans , Japan , Male , Middle Aged , Neuromuscular Agents/adverse effects , Patient Reported Outcome Measures , Rejuvenation , Treatment Outcome
3.
Dermatol Surg ; 44(11): 1437-1448, 2018 11.
Article in English | MEDLINE | ID: mdl-30096106

ABSTRACT

BACKGROUND: Although commonly practiced, simultaneous onabotulinumtoxinA injections to multiple facial areas have not been investigated in prospective studies. OBJECTIVE: Evaluate safety and efficacy of onabotulinumtoxinA for treatment of forehead lines (FHL) distributed between the frontalis (20 U) and glabellar complex (20 U), with or without simultaneous lateral canthal areas (crow's feet lines [CFL], 24 U) treatment. METHODS: Subjects with moderate to severe FHL were randomized (2:2:1) to onabotulinumtoxinA 40 U, onabotulinumtoxinA 64 U, or placebo. After 180 days, subjects could receive up to 2 additional open-label onabotulinumtoxinA 64 U treatments. RESULTS: The intent-to-treat (ITT) population comprised 787 subjects, and the modified ITT (mITT) population (subjects with psychological impact) comprised 568. After 30 days, onabotulinumtoxinA 40 U and 64 U significantly improved investigator- and subject-assessed FHL severity by at least 2 Facial Wrinkle Scale (FWS) grades in 45.6% and 53.0% of ITT subjects, respectively, versus 0.6% receiving placebo (both, p < .0001). Significantly more mITT subjects receiving onabotulinumtoxinA achieved investigator- and subject-assessed FWS ratings of none/mild versus placebo (p < .0001). OnabotulinumtoxinA was well tolerated. CONCLUSION: OnabotulinumtoxinA distributed between the frontalis and glabellar complex, with or without additional CFL injections, was safe and effective for treatment of moderate to severe FHL.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Cosmetic Techniques , Face , Neuromuscular Agents/therapeutic use , Skin Aging/drug effects , Botulinum Toxins, Type A/administration & dosage , Double-Blind Method , Female , Humans , Injections , Male , Middle Aged , Neuromuscular Agents/administration & dosage , Treatment Outcome
4.
Dermatol Surg ; 43 Suppl 3: S274-S284, 2017 Dec.
Article in English | MEDLINE | ID: mdl-33065953

ABSTRACT

BACKGROUND: Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies. OBJECTIVE: To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.

5.
Aesthetic Plast Surg ; 41(5): 1186-1197, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28733805

ABSTRACT

BACKGROUND: This study evaluated the safety and efficacy of onabotulinumtoxinA in Japanese subjects with crow's feet lines (CFL). METHODS: This 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. RESULTS: 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 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. CONCLUSIONS: Treatment 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 I: 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 .


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Neuromuscular Agents/administration & dosage , Rejuvenation/physiology , Skin Aging/drug effects , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Esthetics , Female , Follow-Up Studies , Humans , Injections, Intralesional , Injections, Subcutaneous , Japan , Kaplan-Meier Estimate , Male , Middle Aged , Patient Satisfaction/statistics & numerical data , Reference Values , Skin Aging/physiology , Treatment Outcome
6.
Dermatol Surg ; 42(9): 1094-101, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27427996

ABSTRACT

BACKGROUND: 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. OBJECTIVE: To assess the effect of repeated onabotulinumtoxinA treatment for reduction of glabellar lines at rest. METHODS: 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). RESULTS: 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. CONCLUSION: Subjects repeatedly treated with onabotulinumtoxinA showed progressive improvement in glabellar lines at rest.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Neuromuscular Agents/administration & dosage , Skin Aging , Adult , Age Factors , Cosmetic Techniques , Drug Administration Schedule , Female , Forehead , Humans , Male , Middle Aged , Rest , Retreatment
7.
Dermatol Surg ; 42(5): 598-607, 2016 May.
Article in English | MEDLINE | ID: mdl-27110893

ABSTRACT

BACKGROUND: Duration of esthetic treatments may contribute to subject satisfaction. OBJECTIVE: Describe response duration with onabotulinumtoxinA in crow's feet lines (CFL) and the association of duration with perception of improvement. METHODS: Subjects from 2 double-blind, placebo-controlled trials received onabotulinumtoxinA 24 U in CFL; Study 2 subjects could also receive 20 U in glabella. At Day 30, responders achieved ≥1-grade improvement in Facial Wrinkle Scale (FWS) scores. Median duration of effect for responders and for responders stratified by Subject's Global Assessment of Change in CFL (SGA-CFL) was determined. RESULTS: Of 1,362 subjects, 833 received onabotulinumtoxinA. In Study 2, 305 subjects also received 20 U in glabella. In Study 1 (150-day follow-up), per investigator and subject assessments, respectively, median response duration was 125 and 144 days for dynamic lines and 137 and 148 days for static lines. Median response duration for dynamic and static lines in Study 2 (120-day follow-up) was 119 to 121 days per investigator and subject assessments. Subjects reporting greater improvement on the SGA-CFL tended to have a longer duration of response on investigator FWS scores at maximum smile. CONCLUSION: Response duration with onabotulinumtoxinA in CFL was ≥4 months. Subject perception of CFL improvement may be associated with response duration.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Cosmetic Techniques , Eye , Neuromuscular Agents/therapeutic use , Skin Aging/drug effects , Adult , Aged , Aged, 80 and over , Double-Blind Method , Esthetics , Female , Humans , Male , Middle Aged , Patient Satisfaction , Treatment Outcome
8.
Dermatol Surg ; 42(3): 410-9, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26863598

ABSTRACT

BACKGROUND: Various onabotulinumtoxinA doses are effective in treating forehead lines (FHL), with a trend toward lower doses. OBJECTIVE: To evaluate efficacy and safety of onabotulinumtoxinA dose-ranging treatment of FHL when the frontalis area and glabellar complex are treated together. MATERIALS AND METHODS: 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. RESULTS: 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%]). CONCLUSION: 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(s)
Acetylcholine Release Inhibitors/administration & dosage , Botulinum Toxins, Type A/administration & dosage , Skin Aging/drug effects , Acetylcholine Release Inhibitors/adverse effects , Adult , Botulinum Toxins, Type A/adverse effects , Double-Blind Method , Female , Forehead , Headache/chemically induced , Humans , Male , Middle Aged , Nasopharyngitis/chemically induced , Patient Satisfaction , Plasma Skin Regeneration/methods , Self Concept , Time Factors , Treatment Outcome
9.
Dermatol Surg ; 41(4): 447-56, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25789814

ABSTRACT

BACKGROUND: Patterns of crow's feet lines (CFLs) vary among individuals. OBJECTIVE: To characterize distribution and predictors of CFL patterns. METHODS: Patterns of CFLs (full fan, lower fan, central fan, and upper fan) were evaluated at maximum smile and at rest from photographs of subjects with moderate-to-severe CFLs. Relationships between CFL pattern and severity, age, gender, and subject-reported outcomes were explored. RESULTS: Evaluations of 2,699 photographs from 1,392 subjects were conducted; 1,389 and 1,310 had evaluable CFL patterns at maximum smile and at rest, respectively. Lower-fan, central-fan, and full-fan patterns were identified in 28.4% to 34.7% at maximum smile and 27.7% to 33.9% at rest; upper fan was found in ∼5%. The pattern distribution of CFLs demonstrated a relationship to baseline CFL severity, age, and gender; full-fan and lower-fan patterns were more common in severe versus moderate CFL at maximum smile; full fan increased with age. Lower fan was more common in males. Subjects with full fan at maximum smile were most dissatisfied with their appearance and perceived themselves to look older versus other patterns. CONCLUSION: Baseline CFL severity, age, and gender may predict fan pattern. Patterns may progress with age from central to lower fan or full fan. Pattern heterogeneity of CFLs suggests that tailored treatment may be warranted.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Patient Satisfaction , Self Concept , Skin Aging/drug effects , Acetylcholine Release Inhibitors/administration & dosage , Adult , Cosmetic Techniques , Cross-Sectional Studies , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Surveys and Questionnaires
10.
Dermatol Surg ; 41 Suppl 1: S67-74, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25548848

ABSTRACT

BACKGROUND: Although millions of aesthetic procedures are performed annually, few patient-reported outcome (PRO) measures have been used in this setting. OBJECTIVE: To evaluate the impact of onabotulinumtoxinA treatment for crow's feet lines (CFL) on relevant psychological variables and self-perception of age/appearance in subgroup populations. MATERIALS AND METHODS: Facial Lines Outcomes (FLO-11) Questionnaire, Self-Perception of Age (SPA), and Subject Global Assessment of Change in CFL (SGA-CFL) were PRO measures administered in 2 Phase 3, double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines (GL). Patient-reported outcome measures were analyzed by subgroups (age, gender, and baseline CFL severity). Subject satisfaction with appearance was also analyzed. RESULTS: Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact (FLO-11 Items 2, 5, and 8) versus placebo at Day 30 (p ≤ .05). OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 (p ≤ .05) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL. Overall, subjects were satisfied with their appearance. CONCLUSION: OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance, attractiveness, tiredness, age, and satisfaction versus placebo. Subjects treated for CFL and GL experienced even greater effects.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Neuromuscular Agents/therapeutic use , Patient Satisfaction , Self Concept , Skin Aging/drug effects , Adult , Double-Blind Method , Eye , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Treatment Outcome
11.
Dermatol Surg ; 41(6): 702-11, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25993609

ABSTRACT

BACKGROUND: This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow's feet lines (CFL). OBJECTIVE: To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines (GL) in subjects with moderate-to-severe CFL and GL (maximum smile). MATERIALS AND METHODS: This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U (CFL only; n = 227) or 44 U (24 U for CFL + 20 U for GL; n = 260) to retreatment with the same dose. Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U (n = 101) or placebo (n = 96). Primary efficacy end point (Day 30) was the proportion of subjects who achieved a CFL severity rating of none or mild (maximum smile) on the investigator-assessed Facial Wrinkle Scale (FWS). Additional efficacy end points and adverse events were evaluated. RESULTS: Responder rates (primary end point) were significantly greater in onabotulinumtoxinA-treated groups (24 U: 56.5%; 44 U: 63.6%; placebo: 1.1%; p < .001). Improvements on most patient-reported outcomes (PROs) favored the 44-U group over the 24-U group. Adverse events did not differ among groups; most were mild or moderate. CONCLUSION: Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs. Adverse event profiles remain consistent with approved GL labeling.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Neuromuscular Agents/therapeutic use , Skin Aging/drug effects , Adult , Blepharoptosis/chemically induced , Botulinum Toxins, Type A/adverse effects , Cosmetic Techniques/adverse effects , Double-Blind Method , Eye , Female , Forehead , Headache/chemically induced , Hematoma/chemically induced , Humans , Male , Middle Aged , Neuromuscular Agents/adverse effects , Patient Satisfaction , Self Concept , Treatment Outcome
12.
Dermatol Surg ; 41(1): 102-12, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25485803

ABSTRACT

BACKGROUND: This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL). METHODS: This multicenter, double-blind, placebo-controlled, repeat treatment, 7-month study randomized subjects with moderate-to-severe CFL and GL (maximum contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306). Coprimary end points were investigator-assessed and subject-assessed proportion of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 (maximum smile; Day 30, Cycle 1). Additional efficacy end points and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Investigator and subject responder rates were: CFL, 54.9% and 45.8%; CFL + GL, 59.0% and 48.5%; and placebo, 3.3% (both), respectively. Responder rates on other end points also significantly favored onabotulinumtoxinA treatments. Most AEs were mild or moderate. Two subjects discontinued: 1 serious AE unrelated to treatment (myocardial infarction) and 1 treatment-related AE (injection site pain). CONCLUSION: OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Cosmetic Techniques , Neuromuscular Agents/therapeutic use , Skin Aging , Adult , Botulinum Toxins, Type A/adverse effects , Cosmetic Techniques/adverse effects , Cosmetic Techniques/psychology , Double-Blind Method , Eye , Female , Forehead , Headache/chemically induced , Hematoma/chemically induced , Humans , Male , Middle Aged , Neuromuscular Agents/adverse effects , Pain/chemically induced , Patient Satisfaction , Self Concept , Treatment Outcome
13.
Dermatol Surg ; 40(11): 1181-90, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25347451

ABSTRACT

BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. METHODS: 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. RESULTS: 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. CONCLUSION: Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Skin Aging/drug effects , Adult , Aged , Botulinum Toxins, Type A/administration & dosage , Botulinum Toxins, Type A/adverse effects , Double-Blind Method , Female , Humans , Male , Middle Aged
14.
Dermatol Surg ; 38(11): 1794-803, 2012 Nov.
Article in English | MEDLINE | ID: mdl-23106853

ABSTRACT

BACKGROUND: Duration of effect of aesthetic treatments with botulinum toxin potentially influences subject satisfaction, treatment frequency, and annual costs, but quantitative outcomes for measuring duration of effect and correlations with subject satisfaction have yet to be fully elucidated. METHODS AND MATERIALS: Phase III clinical trials with similar designs were identified and their data pooled to ascertain duration of clinical effect of onabotulinumtoxinA in glabellar muscles. Duration was calculated using the Kaplan-Meier method for investigator-rated Facial Wrinkle scale (FWS) scores and subject global assessment (SGA) of glabellar lines. Responders were determined according to FWS score at maximum contraction and at repose 30 days after injection. RESULTS: Data from four trials with 621 onabotulinumtoxinA-treated (20 U) subjects were analyzed, 523 of these (84.2%) were identified as day-30 responders on the FWS at maximum contraction. Pooled median duration of effect for day-30 responders was 120 days for FWS at maximum contraction and 131 days for FWS at repose. Higher day 30 SGA scores were correlated with a greater duration of effect on dynamic, but not static lines. CONCLUSION: Treatment of glabellar lines with 20 U of onabotulinumtoxinA resulted in sustained clinical benefit for 4 months in more than 50% of responders; subject satisfaction increased with duration of effect.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Cosmetic Techniques , Skin Aging , Adult , Clinical Trials, Phase III as Topic , Female , Forehead , Humans , Male , Middle Aged , Muscle Contraction/drug effects , Patient Satisfaction , Randomized Controlled Trials as Topic , Time Factors
15.
Iperception ; 12(6): 20416695211058799, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34881018

ABSTRACT

The present study aims to explore the influence of masculine/feminine changes on the attractiveness evaluation of one's own face, and examine the relationship of this attractiveness evaluation and the similarities between masculine/feminine faces and original faces. A picture was taken from each participant and considered as his or her original self-face, and a male or female face with an average attractiveness score was adopted as the original other face. Masculinized and feminized transformations of the original faces (self-face, male other face, and female other face) into 100% masculine and feminine faces were produced with morphing software stepping by 2%. Thirty female participants and 30 male participants were asked to complete three tasks, i.e., to "like" or "not like" the original face judgment of a given face compared to the original face, to choose the most attractive face from a morphed facial clip, and to subjectively evaluate the attractiveness and similarity of morphed faces. The results revealed that the acceptable range of masculine/feminine transformation for self-faces was narrower than that for other faces. Furthermore, the attractiveness ratings for masculinized or femininized self-faces were correlated with the similarity scores of the faces with the original self-faces. These findings suggested that attractiveness enhancement of self-face through masculinity/femininity must be within reasonable extent and take into account the similarity between the modified faces and the original self-face.

16.
Percept Mot Skills ; 128(1): 115-134, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33121355

ABSTRACT

Adopting eye-tracking measures, we explored the influence of art experience on the aesthetic evaluation of computer icons. Participants were 27 college students with art training and 27 laypersons. Both groups rated icons of varying complexity and symmetry for "beauty" while we recorded participants' eye movements. Results showed that art-trained participants viewed the icons with more eye fixations and had shorter scanning paths than participants in the non-art group, suggesting that art-trained participants processed the icons more deliberately. In addition, we observed an interaction effect between art experience and symmetry. For asymmetrical icons, art-trained participants' ratings tended to be higher than those of lay persons; for symmetric icons, there was no such rater difference. The different visual patterns associated with aesthetic evaluations by these two participant groups suggest that art experience plays a pivotal role in the aesthetic appreciation of icons and has important implications for icon design strategy.


Subject(s)
Beauty , Eye Movements , Computers , Esthetics , Humans , Students
17.
Chem Commun (Camb) ; 57(54): 6652-6655, 2021 Jul 06.
Article in English | MEDLINE | ID: mdl-34128009

ABSTRACT

The ubiquitous presence of the indole fragment in natural products and drugs asks for ever novel syntheses. We report an unprecedented mild, two-step synthesis of 2-tetrazolo substituted indoles based on the Ugi-tetrazole reaction combined with an acidic ring closure. A gram-scale synthesis, a bioactive compound and further transformations were performed.

18.
Front Psychol ; 12: 778695, 2021.
Article in English | MEDLINE | ID: mdl-35095661

ABSTRACT

Reactive aggression is a type of aggression that has severe consequences in individual's psychosocial development and social stability. Trait anger is a risk personality factor for reactive aggression. However, the mediating mechanism of this relationship has not been sufficiently analyzed. We proposed that hostile attribution bias and anger rumination may be cognitive factors that play mediating roles in the relationship between trait anger and reactive aggression. To test this hypothesis, a sample of 600 undergraduates (51.67% females, M age = 20.51, SD = 1.11) participated in this study. Findings showed that hostile attribution bias, anger rumination sequentially mediated the association between trait anger and reactive aggression. These results highlight the importance of anger rumination and hostile attribution bias to explain the link between trait anger and reactive aggression in undergraduates. The findings of the present study also provide valuable information about the role of negative cognitive activities (e.g., hostile attribution, ruminate in anger emotion) in high trait anger individual may trigger reactive aggression. The limitations of the study are discussed, along with suggestions for future research.

19.
Dermatol Surg ; 36 Suppl 4: 2168-71, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21134048

ABSTRACT

BACKGROUND: OnabotulinumtoxinA is an established treatment for glabellar frown lines, but its effects on lines at repose are less well documented. OBJECTIVE: To assess the effect of onabotulinumtoxinA on elimination of mild lines at repose. METHODS: Data from two randomized, double-blind, placebo-controlled studies were included. Elimination of mild lines at repose was defined as change from mild to none on the Facial Wrinkle Scale. RESULTS: Analysis included 183 participants who received 20 U of onabotulinumtoxinA and 64 participants who received placebo, all with mild lines at repose at baseline. Participants were evaluated 7, 30, 60, 90, and 120 days posttreatment. Compared to placebo, onabotulinumtoxinA-treated participants were significantly more likely to have their lines at repose eliminated at each study day; [odds ratios ranged from 42.7 (95% confidence interval (CI)=12.9-141.9) at day 30 to 4.9 (95% CI=2.2-10.8) at day 120 (p<.0001 at each day)]. The highest response rate was observed at day 30 (68%). CONCLUSION: OnabotulinumtoxinA has demonstrated the ability to eliminate mild glabellar lines at repose for a significant number of patients. This effect, albeit more subtle than the effect on dynamic or more severe glabellar lines, may be an important treatment goal for patients who seek a smoother appearance at repose.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Neuromuscular Agents/administration & dosage , Skin Aging/drug effects , Adult , Aged , Double-Blind Method , Female , Forehead , Humans , Injections, Intramuscular , Male , Middle Aged , Young Adult
20.
Org Lett ; 21(5): 1484-1487, 2019 03 01.
Article in English | MEDLINE | ID: mdl-30740981

ABSTRACT

Activation of disulfides with N-halogen succinimide in the presence of TEMPO allows insertion reaction by an isocyanide, the product of which can further accept a wide range of nucleophiles for the generation of isothioureas and related molecular moieties. This new procedure overcomes previous methods that accept essentially only aryl amines as the third nucleophilic component. The diverse nucleophiles usable in our new protocol make this approach a general method for de novo synthesis of many S-containing heterocycles.

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