Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial.

BACKGROUND: Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition. OBJECTIVE: To assess the efficacy and safety of ESTLF compared with RESL for the treatment of nasolabial folds (NLFs). MATERIALS AND METHODS: In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to ESTLF on one side of the face and RESL on the other side and were followed up for 9 months. The primary end point was change in WSRS score from the baseline to Month 1 (M1). Secondary end points included changes in WSRS score at other time points, aesthetic improvement, wrinkle volume quantification, adverse events, and local tolerance. RESULTS: The efficacy difference between ESTLF and RESL at M1 was in favor of ESTLF (-0.16, CI, -0.28 to -0.03]), demonstrating its noninferiority. Considering other time points, significant differences were observed at 3 and 6 months for ESTLF, assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated. CONCLUSION: ESTLF is effective and well tolerated for the treatment of NLFs.

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials.

BACKGROUND: Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem. OBJECTIVE: To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials. MATERIALS AND METHODS: Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points. RESULTS: Among enrolled and treated subjects (N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was -33.84 for letibotulinumtoxinA subjects compared with -1.37 for placebo subjects (p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity (p < .0001). CONCLUSION: LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome.

International Consensus Recommendations on the Aesthetic Usage of Ready-to-Use AbobotulinumtoxinA (Alluzience).

Alluzience (abobotulinumtoxinA RTU; Ipsen, Paris, France and Galderma SA, Lausanne, Switzerland) is the first ready-to-use (RTU) botulinum toxin type A liquid solution approved for the treatment of glabellar lines in Europe. In this article, the authors provide consensus recommendations on the aesthetic usage of abobotulinumtoxinA RTU. Members of the International Board on Alluzience convened to develop consensus on the treatment of glabellar lines as well as other facial wrinkles based on their own extensive experience. Consensus recommendations were developed to provide practical guidelines for injection of abobotulinumtoxinA RTU. General guidance on proper assessment, treatment planning, and patient education is provided, as well as specific injection guidelines per indication. Indications covered include glabellar lines, crow's feet, horizontal forehead lines, lateral eyebrow lift, lower eyelid wrinkles, bunny lines, drooping nasal tip, perioral wrinkles, drooping mouth corners, masseter hypertrophy, hollow cheek lines, dimpled chin, and platysmal bands. These guidelines provide a practical framework to support routine injection of facial muscles with Alluzience.

Long-term Performance and Safety of Princess VOLUME PLUS Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study.

BACKGROUND: Hyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation. OBJECTIVES: This postmarket investigation evaluated the long-term performance and safety of and patient satisfaction with Princess VOLUME PLUS Lidocaine (PVPL; now Saypha VOLUME PLUS Lidocaine) for the correction of midface volume deficit (MVD). METHODS: This was an open-label, prospective, interventional, multicenter, noncomparative, postapproval study of 91 patients with moderate or severe MVD (grade 2 or 3 on the 5-point Midface Volume Deficit Severity Scale, or MVDSS). At Day 0 (Visit 1), patients were treated with PVPL; they returned for follow-up assessments at weeks 2, 4, 12, 24, 36, and 52 and had long-term follow-up until 36 months. A touch-up treatment could be done at week 2. The performance was assessed with the MVDSS, Global Aesthetic Improvement Scale (GAIS), and a subject satisfaction scale. Adverse events were collected to assess safety throughout the study. RESULTS: Four weeks after treatment, 100% of injected patients improved by ≥1 grade on the MVDSS compared to baseline, with improvements still visible in 77% of patients 52 weeks after treatment. Based on the GAIS and post hoc survival analysis, the treatment effect was maintained for a median of 386 days, and in severe cases the effect lasted longer, which seemed to be independent of the volume injected at baseline. No serious side effects were reported. Results were substantiated by high patient satisfaction. CONCLUSIONS: Princess VOLUME PLUS Lidocaine was perceived as safe and effective by patients and investigators, with long-term aesthetic improvement in moderate and severe cases.

PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data.

BACKGROUND: Despite a growing interest among men in cosmetic procedures such as botulinum toxin, comparator clinical trial data in this population are limited. OBJECTIVES: The authors sought to compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines. METHODS: Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20 U prabotulinumtoxinA (n = 25) or 20 U onabotulinumtoxinA (n = 31) in the EVB-003 Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. RESULTS: Compared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1-point improvement on the Glabellar Line Scale at maximum frown were higher at all postbaseline time points for prabotulinumtoxinA-treated males (P > 0.05 at all visits) by an absolute overall mean difference of 10.1% across all visits. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis. CONCLUSIONS: The percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across all measures, differences between the 2 treatment groups did not reach statistical significance. Further study is warranted to establish if these post-hoc analyses observations are reproducible in a larger male patient population.

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.

Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study.

In aesthetic practice, wrinkles in the upper face are commonly treated with repeat-dose injections. The objective of this study was to investigate the safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA in the combined treatment of moder-ate to severe upper facial lines (UFL) [glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)]. Healthy subjects (≥18 years) with moderate to severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contrac-tion were administered 54 to 64 U of incobotulinumtoxinA (GFL, 20 U; HFL, 10 to 20 U; LPL, 24 U) in up to four, 120-day treatment cycles. Adverse events (AE) were recorded for each cycle until 120 ± 7 days after treatment. Investigator-assessed MAS scores were evaluated for each treated area at maximum contraction on day 30 [responder = score of “none” (0) or “mild” (1)]. Subject-assessed scores for overall appearance of the upper face of “much improved” or “very much improved” were noted at day 30 of each treatment cycle on the Global Impression of Change Scale (GICS). Overall, 140 subjects were treated, and 125 subjects completed the study. Mean injected units per injection cycle ranged from 56.3 U to 57.7 U. During the four-cycle study period 17.1% of total treated subjects experienced a treatment emergent adverse event (TEAE). TEAEs of special interest were documented for 9 subjects (6.4%), in 6 of these subjects (4.3%) the TEAEs were related to treatment. No clinically significant mean changes in laboratory and vital-sign values were observed from screening to final-treatment visit. Over the study interval, a response rate of > 80% on the investigator-assessed MAS was reported for all treated areas except HFL. Greater than 80% of subjects in cycles 1, 3, and 4 and 78.5% of subjects in cycle 2 reported ratings of “much improved” or “very much improved” on the GICS for the overall appearance of the upper face. Incobotu-linumtoxinA for the repeat-dose treatment of UFL is safe and well tolerated with a stable safety profile, without new formation of neutralizing antibodies and has excellent efficacy during prolonged administration. J Drugs Dermatol. 2020;19(5):461-469. doi:10.36849/JDD.2020.5013.

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.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines. METHODS: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30. RESULTS: Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related. CONCLUSIONS: A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

Efficacy and Safety of 3 New Resilient Hyaluronic Acid Fillers, Crosslinked With Decreased BDDE, for the Treatment of Dynamic Wrinkles: Results of an 18-Month, Randomized Controlled Trial Versus Already Available Comparators.

BACKGROUND: Three new hyaluronic acid (HA)-based fillers made of long chains crosslinked with reduced amounts of 1,4-butanediol diglycidyl ether (BDDE) were developed for the treatment of dynamic facial areas. Their resilience and increased stretching ability were optimized to ease injectors' practice and provide patients with most natural aesthetic results. OBJECTIVE: This study aimed at evaluating the efficacy, durability, and safety of these resilient HA fillers versus commercially available comparator gels. METHODS: A prospective, monocentric, split-face, double-blinded, randomized, controlled trial was performed on 90 subjects presenting moderate to severe bilateral nasolabial folds (NLFs). Efficacy parameters were assessed over 18 months, including improvement on the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale, as well as quantitative imaging and analysis of NLF correction. Physicians' and subjects' satisfaction, together with safety, were assessed throughout the study. RESULTS: The new HA fillers offered efficacy and safety profiles at least equivalent to comparators. These dynamic facial fillers elicited higher satisfaction immediately after injection but also on the long run, according to both investigators and subjects. CONCLUSION: This pilot trial demonstrated the numerous benefits of 3 new resilient HA fillers with decreased BDDE crosslinking in the treatment of dynamic wrinkles.

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.

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.

Update of the S1 guidelines on the definition and treatment of primary hyperhidrosis.

Focal hyperhidrosis can have a considerable impact on social and occupational activities and be associated with significant impairment in quality of life. Primary (idiopathic) hyperhidrosis is neither caused by systemic disorders nor by external factors. It usually occurs in areas characterized by a high density of sweat glands such as the axillae and hands. The diagnosis of focal hyperhidrosis is based on history and clinical findings. Supplementary diagnostic tests include gravimetry (measurement of the amount of sweat) and the iodine starch test (which shows the area of sweating). Treatment options consist of topical agents, botulinum toxin A injections, iontophoresis, treatment with radiofrequency, microwaves, or ultrasound as well as surgical procedures (axillary suction curettage, sympathectomy). Systemic agents such as anticholinergics may also be used. Selection of the most appropriate therapeutic approach depends on the site affected, prior treatment as well as the patient's requests.