Botulinum Toxin Type A in the Treatment of Primary Axillary Hyperhidrosis:A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety in Chinese Patients

Aesthet Surg J. 2026 Jan 19:sjaf260. doi: 10.1093/asj/sjaf260. Online ahead of print.

ABSTRACT

BACKGROUND: The efficacy and safety of botulinum toxin type A (BoNTA) treatment for primary axillary hyperhidrosis (PAH) have not been explored in the Chinese population.

OBJECTIVES: The objective was to evaluate efficacy and safety of 1 intradermal BoNTA injection in Chinese PAH cases.

METHODS: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Patients were randomized to an experimental group or the control group at a ratio of 3:1 and received either BoNTA or a placebo once. The primary efficacy endpoint was the proportion of patients who experienced an over 50% reduction in axillary sweat weight at Week 4 posttreatment compared to baseline. The key secondary efficacy endpoints were the percentage changes in axillary sweat weight at Weeks 1, 4, 8, and 16 posttreatment.

RESULTS: A total of 344 patients were randomized to the experimental group (n = 258) or the control group (n = 86). The proportions of patients who experienced an over 50% reduction in axillary sweat weight at Week 4 posttreatment were 83.72% (216/258) in the experimental group and 55.81% (48/86) in the control group, respectively. The between-group difference was 27.91% (P < .001). BoNTA treatment yielded a significant reduction in axillary sweat weight, hyperhidrotic area, hyperhidrosis disease severity scale (HDSS) scores, and grade of bromhidrosis. The patients in the experimental group reported significantly higher satisfaction scores than those in the control group. BoNTA treatment was well tolerated. Neither group experienced suspected unexpected serious adverse reactions, or adverse events or adverse drug reactions leading to withdrawal or death.

CONCLUSIONS: One intradermal 50-U BoNTA treatment led to a significant reduction in axillary sweat weight, axillary hyperhidrotic area, HDSS scores, and axillary bromhidrosis grades in Chinese PAH patients. The therapeutic effect was maintained for 16 weeks posttreatment, with a favorable safety profile.

PMID:41553927 | DOI:10.1093/asj/sjaf260

A predictive model for postoperative compensatory hyperhidrosis in primary palmar hyperhidrosis: a retrospective cohort study

J Thorac Dis. 2025 Dec 31;17(12):11253-11261. doi: 10.21037/jtd-2025-1562. Epub 2025 Dec 26.

ABSTRACT

BACKGROUND: While sympathectomy remains the optimal surgical intervention for severe primary palmar hyperhidrosis (PPH), compensatory hyperhidrosis (CH) has emerged as the most significant factor contributing to postoperative patient regret. This retrospective study aimed to identify risk factors and develop a predictive model for moderate-to-severe compensatory hyperhidrosis (msCH) in patients with PPH.

METHODS: A total of 1,013 patients were retrieved from the institutional database between 2014 and 2024. Logistic regression modeling was utilized to identify risk factors for msCH. A nomogram for predicting msCH was developed accordingly.

RESULTS: Of the initial cohort, there were 903 patients included in the final analysis, among whom 182 (20.2%) developed msCH. The following factors were identified as independent risk factors for msCH: age >25 years [odds ratio (OR) 3.32, 95% confidence interval (CI): 2.23-4.95, P<0.01], smoking history (OR 6.46, 95% CI: 4.37-9.54, P<0.01), higher body mass index (BMI) (OR 1.68, 95% CI: 1.10-2.56, P=0.02), palmar-axillary hyperhidrosis (OR 2.37, 95% CI: 1.57-3.57, P<0.01), and T3 sympathectomy (OR 3.14, 95% CI: 2.03-4.85, P<0.01). A predictive nomogram for msCH was developed based on these factors. Receiver operating characteristic (ROC) curve analysis demonstrated an area under the curve (AUC) of 0.839, indicating good predictive performance.

CONCLUSIONS: Age >25 years, smoking history, higher BMI, palmar-axillary hyperhidrosis, and T3 sympathectomy were independent risk factors for msCH. Based on these factors, a predictive model for msCH was developed and showed high predictive accuracy.

PMID:41522169 | PMC:PMC12780405 | DOI:10.21037/jtd-2025-1562

Beyond the Axilla: The Evolving Role of Botulinum Toxin in the Treatment of Facial, Scalp, and Focal Hyperhidrosis

Clin Dermatol. 2025 Dec 27:S0738-081X(25)00336-0. doi: 10.1016/j.clindermatol.2025.12.003. Online ahead of print.

ABSTRACT

Botulinum toxin type A (BoNTA) is an established treatment for focal hyperhidrosis of the axillae and palms, but its use has recently expanded to include craniofacial, facial, and scalp hyperhidrosis. This systematic review with narrative synthesis evaluates the clinical use of BoNTA for focal hyperhidrosis across multiple anatomical sites. A structured search of PubMed/MEDLINE, Embase, and Scopus was conducted for English-language human studies published between 2000 and 2025. Original clinical studies reporting outcomes related to sweat reduction, disease severity, quality of life, duration of effect, or adverse events were included, while reviews and non-original publications were used only for background and citation tracking. A total of 33 original clinical studies met inclusion criteria. Evidence was strongest for axillary hyperhidrosis, where randomized controlled trials consistently demonstrated substantial reductions in sweating and sustained patient-reported benefit. Palmar hyperhidrosis showed reliable efficacy, although treatment was limited by injection discomfort and transient weakness. Evidence for craniofacial, facial, and scalp hyperhidrosis consisted primarily of small cohorts and case series, which nevertheless reported meaningful symptom improvement and acceptable safety profiles despite heterogeneity in dosing and injection techniques. Overall, BoNTA remains a cornerstone therapy for focal hyperhidrosis, and while evidence beyond the axillae is less robust, available data support its use in selected patients and underscore the need for larger, standardized studies in craniofacial and scalp hyperhidrosis.

PMID:41461243 | DOI:10.1016/j.clindermatol.2025.12.003

Three-Year Results Following Microwave Therapy in Patients with Severe Primary Axillary Hyperhidrosis

Aesthetic Plast Surg. 2025 Dec 1. doi: 10.1007/s00266-025-05469-5. Online ahead of print.

ABSTRACT

Microwave therapy (Miradry®) is an approved treatment for axillary hyperhidrosis (AH). There are several studies in the literature that show favourable safety and efficacy profile, although a few follow up patients under longer period and on larger cohort patients. In the present study, we report three-year results after microwave therapy for AH. At dermatology clinic in Östergötland 103 patients with severe AH received one or two Miradry® treatments, between 2020 and 2022. Patients were examined at several intervals during study period. Between March 2024 and June 2025, 87 patients were contacted by post and asked to complete HDSS (Hyperhidrosis Disease Severity Scale) and Hyperhidrosis Quality of Life (HidroQoL©); 45 patients have responded to our survey (response rate 51.7%). Statistically significant improvement was observed in both HDSS (from medians 3 at the study inclusion to medians 2 at 3 year) and HidroQoL© (medians 26 at baseline and medians 6 at 3 year). As a conclusion, our data demonstrate that microwave therapy is a promising long-term efficient treatment for AH and significantly improves quality of life in patients suffering from severe AH.Level of Evidence II 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 .

PMID:41326743 | DOI:10.1007/s00266-025-05469-5

Altered Th17/Treg balance and therapeutic targeting of RORgamma in primary focal hyperhidrosis

Front Immunol. 2025 Oct 17;16:1656632. doi: 10.3389/fimmu.2025.1656632. eCollection 2025.

ABSTRACT

BACKGROUND: Primary focal hyperhidrosis (PFH) significantly impacts patients’ physical and mental health, yet its underlying mechanisms remain unclear.

METHODS: This study involved 80 healthy controls and 60 patients each with primary palmar (PPH), craniofacial (PCH), or axillary hyperhidrosis (PAH). Peripheral blood mononuclear cells (PBMCs) were analyzed via flow cytometry to assess Th17 and Treg cell populations. Cytokine levels were measured in patient serum using ELISA, while sweat gland tissue from PAH patients underwent gene expression analysis. A pilocarpine-induced mouse model of hyperhidrosis was used to test SR2211, a RORγ inverse agonist.

RESULTS: PFH patients exhibited a disrupted Th17/Treg balance, with increased Th17 and decreased Treg cells across all subtypes compared to controls. Elevated IL-17 and IL-6 and reduced IL-10 and TGF-β1 levels were observed in PFH serum. Sweat glands showed increased RORγt and decreased FOXP3 expression. In mice, SR2211 treatment reduced sweat secretion, secretory granules, and serum acetylcholine. It also lowered Th17 infiltration, serum IL-17/IL-6, and IL-17A expression in sweat glands.

DISCUSSION: PFH is associated with a Th17/Treg immune imbalance. SR2211 alleviated hyperhidrosis and Th17-related inflammation in mice, highlighting the potential of targeting the RORγ-Th17 axis as a therapeutic strategy for PFH.

PMID:41181099 | PMC:PMC12575253 | DOI:10.3389/fimmu.2025.1656632

Food and Beverage Habits Among Individuals with Primary Hyperhidrosis: A Case-Control Survey in Sweden

Clin Cosmet Investig Dermatol. 2025 Oct 24;18:2769-2776. doi: 10.2147/CCID.S547497. eCollection 2025.

ABSTRACT

AIM: Excessive sweat production in primary hyperhidrosis (PH) can lead to water and mineral loss, yet data on patients’ dietary habits are limited.

PURPOSE: To explore associations between food and beverage consumption and severe PH.

PATIENTS AND METHODS: Participants with primary palmar and axillary hyperhidrosis (n=171) and without hyperhidrosis (n=165) completed a validated questionnaire on food and beverage habits at two hospitals in northern Sweden. Frequency and quantity of specific foods and beverages were compared between groups.

RESULTS: A total of 336 individuals participated in this study (men, n=109; women, n=218; unspecified sex, n=9). Individuals with PH were younger (18-29 years, n=104 vs n=66; p<0.001) and more frequently female compared to controls (n=75 vs 58; p<0.001). Total caffeine consumption was higher in PH (median score: 186.6 vs.151.0; p<0.001), and 57% of individuals with PH consumed energy drinks weekly compared with 39.5% of controls (p<0.001). Spicy foods, fatty foods, fast foods, and sweets were reported to trigger sweating. Women with PH more often reported difficulties replenishing water loss, and increased thirst was the most reported symptom in both men and women.

CONCLUSION: PH was associated with higher caffeine intake, distinct beverage consumption patterns, and self-reported fluid loss symptoms. These findings indicate potential associations between diet and PH and may inform patient education and future research, although causality cannot be inferred from this study.

PMID:41164747 | PMC:PMC12560645 | DOI:10.2147/CCID.S547497

20-Year Efficacy of Endoscopic Thoracic Sympathectomy for Primary Hyperhidrosis: A Cohort Study

J Clin Med. 2025 Jul 8;14(14):4831. doi: 10.3390/jcm14144831.

ABSTRACT

Background: Primary focal hyperhidrosis, characterized by excessive sweating primarily affecting the hands and axillae, can significantly impact quality of life. Bilateral thoracic sympathectomy is the gold standard treatment, providing permanent resolution of palmar hyperhidrosis. Most studies evaluating outcomes and patient satisfaction after sympathectomy focus on short- to medium-term follow-up, typically up to 5 years. This study aimed to assess anxiety, satisfaction, and sweat redistribution 20 years after bilateral endoscopic thoracic sympathectomy. Methods: Between January 2002 and December 2003, 106 patients with primary hyperhidrosis underwent bilateral endoscopic thoracic sympathectomy targeting ganglia T2-T3 at our center. The patients were contacted via telephone in 2023 and asked to complete the same survey they had filled out preoperatively and 12 months postoperatively. The survey evaluated sweat redistribution, anxiety, hyperhidrosis-related symptoms, and satisfaction. Anxiety, satisfaction, and perceived sweating were rated using a 5-point visual analog scale (VAS) ranging from 0 (unsatisfied/no symptoms) to 4 (very satisfied/severe symptoms). Results: Of the 106 eligible patients, 24 (22.6%) completed the survey. Most reported persistent anhidrosis (palmar or palmar-axillary) 20 years post-surgery. The survey results remained consistent with those at the 1-year follow-up. Significant sweat redistribution to the abdomen and back was observed. Patient satisfaction remained high, with no significant differences between the 1-year and 20-year assessments. Anxiety significantly decreased compared to preoperative levels (p < 0.001). Conclusions: Bilateral endoscopic thoracic sympathectomy is an effective long-term treatment for reducing excessive sweating. Patient satisfaction remains high over time, despite the persistence of compensatory sweating.

PMID:40725520 | DOI:10.3390/jcm14144831