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Treatment of primary axillary hyperhidrosis with botulinum toxin type a: our experience in 50 patients from 2007 to 2010.

ABSTRACT: Background. Local injections of Botulinum toxin type A (BTX-A) are an effective and safe solution for primary bilateral axillary hyperhidrosis. Traditional treatments are often ineffective and difficult to tolerate. This study was performed to assess the efficacy and safety of Botulinum toxin type A in the treatment of these diseases and to evaluate the reliability of patient's subjective rating in the timing of repeat injections. Methods. From 2007 to 2008, we included in the study and treated a total of 50 patients, and we used the Minor's iodine test and the hyperhidrosis diseases severity scale as initial inclusion criteria and also for evaluating the followup, comparing to patient's subjective rating. We used also a specific questionnaire to evaluate the level of pain, the onset of the effect, any eventual adverse effect of the treatment, the onset of compensatory hyperhidrosis, and the global grade of satisfaction. The data were analyzed using standard statistical methods. Results. 88% of patients were totally satisfied and all patients repeated the treatment during all the study. The symptom-free interval was in median 6 months with an average improving of HDSS of 1.5 points. In 86%, there was a complete accordance between the subjective patient's demand of the repetition of the treatment and the positivity to Minor test and HDSS. No major side effects happened. Conclusion. Local injections of Botulinum toxin type A (BTX-A) result in an effective and safe solution for bilateral axillary primary hyperhidrosis for the absence of significant morbidity, side effects, and lack of efficacy or duration. The only defects are the need of repetition of the treatment and relative costs.

SUBMITTER: Scamoni S

PROVIDER: S-EPMC3483720 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Treatment of primary axillary hyperhidrosis with botulinum toxin type a: our experience in 50 patients from 2007 to 2010.

Scamoni Stefano S Valdatta Luigi L Frigo Claudia C Maggiulli Francesca F Cherubino Mario M

ISRN dermatology 20121017

Background. Local injections of Botulinum toxin type A (BTX-A) are an effective and safe solution for primary bilateral axillary hyperhidrosis. Traditional treatments are often ineffective and difficult to tolerate. This study was performed to assess the efficacy and safety of Botulinum toxin type A in the treatment of these diseases and to evaluate the reliability of patient's subjective rating in the timing of repeat injections. Methods. From 2007 to 2008, we included in the study and treated ...[more]

PMID: 23119179

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Project description:BACKGROUND:Primary focal axillary hyperhidrosis is a chronic distressing disorder affecting both the sexes. When the condition is refractory to conservative management, we should go for more promising therapies like intradermal botulinum toxin A (BtxA) injections in the axilla, and surgical therapies like subcutaneous curettage of sweat glands. AIMS AND OBJECTIVES:The aim of this study is to compare the efficacy, safety and duration of action of intradermal BtxA injections in one axilla and subcutaneous curettage of sweat glands in the other axilla of the same patient with axillary hyperhidrosis. MATERIALS AND METHODS:Twenty patients (40 axillae) received intradermal BtxA injections on the right side (20 axillae) and underwent tumescent subcutaneous curettage of sweat glands on the left side (20 axillae). Sweat production rate was measured using gravimetry analyses at baseline and at 3 months after the procedure. Subjective analyses were done using hyperhidrosis disease severity scale (HDSS) score at baseline, at 3rd and 6th month after the procedure. RESULTS:At 3 months post-treatment, the resting sweat rate in the toxin group improved by 80.32% versus 79.79% in the subcutaneous curettage method (P = 0.21). Exercise-induced sweat rate in the toxin group improved by 88.76% versus 88.8% in the subcutaneous curettage group (P = 0.9). There was a significant difference in the HDSS score after treatment with both the modalities. There were no adverse events with BtxA treatment compared to very minor adverse events with the surgical method. CONCLUSION:Both intradermal BtxA injections and tumescent subcutaneous curettage of sweat glands had a significant decrease in the sweat rates with no significant difference between the two modalities. Hence, in resource poor settings where affordability of BtxA injection is a constraint, subcutaneous curettage of sweat glands can be preferred which has been found equally effective with no or minimal adverse events.

Project description:BackgroundGlycopyrronium tosylate (GT; Qbrexza® [glycopyrronium] cloth, 2.4%) is a topical anticholinergic approved (USA) for primary axillary hyperhidrosis in patients aged ≥ 9 years.ObjectiveThe objective of this study was to compare the pharmacokinetics and safety of GT to oral glycopyrrolate (phase I study) and assess the relationship between glycopyrronium pharmacokinetics and anticholinergic-related adverse events or efficacy with population pharmacokinetics using data from two phase II studies.MethodsIn the phase I study, study staff applied GT to axillae of patients with primary axillary hyperhidrosis (aged 9-65 years) once daily (5 days); oral glycopyrrolate was administered to healthy adults (aged 18-65 years) every 8 hours (15 days). In the phase II studies (NCT02016885 [20 December, 2013], NCT02129660 [2 May, 2014]), adults with primary axillary hyperhidrosis applied topical glycopyrronium (0.8-3.2%) or vehicle to axillae once daily (4 weeks). Pharmacokinetic and adverse event data were collected in all studies.ResultsGlycopyrronium pharmacokinetic parameters were similar between adult and pediatric patients treated with GT; there was no evidence of accumulation. Systemic absorption of glycopyrronium was lower with GT vs oral glycopyrrolate. No anticholinergic-related adverse events occurred with GT in the phase I study, while dry mouth and nasal dryness occurred with oral glycopyrrolate; anticholinergic adverse events occurred in the phase II studies. In the population pharmacokinetic analysis, frequency/severity of anticholinergic-related adverse events increased with higher glycopyrronium concentration; no relationship was observed between efficacy and pharmacokinetic measures.ConclusionsThese studies indicate limited absorption of GT compared to oral glycopyrrolate and a low risk of anticholinergic adverse events with proper GT administration when following instructions for use (wipe each underarm once with same cloth, wash hands, avoid ocular contact).

Project description:BackgroundAlthough sympathectomy is highly effective for improving symptom, compensatory hyperhidrosis (CH) is a major issue. In this study, characteristics of primary hyperhidrosis were investigated in terms of the heart rate variability (HRV) parameters. Classification of hyperhidrosis type and prediction of CH after sympathicotomy were also determined using machine learning analysis.MethodsFrom March 2017 to December 2021, 128 subjects who underwent HRV tests before sympathicotomy were analyzed. T2 and T3 bilateral endoscopic sympathicotomy were routinely performed in patients with craniofacial and palmar hyperhidrosis, respectively. Data collected age, sex, body mass index (BMI), hyperhidrosis type, symptom improvement after sympathicotomy, the degrees of CH after sympathicotomy, and preoperative HRV findings. The independent risk factors associated with the degree of CH after sympathicotomy were investigated. Machine learning analysis was used to determine classification of hyperhidrosis type and prediction of the degree of CH.ResultsPreoperatively, patients with palmar hyperhidrosis presented with significantly larger standard deviation of normal-to-normal (SDNN), root mean square of successive differences (RMSSD), total power (TP), and low frequency (LF) than patients with craniofacial hyperhidrosis after controlling for age and sex (P=0.030, P=0.004, P=0.041, and P=0.022, respectively). More sympathetic nervous predominance was found in craniofacial type (P=0.019). Low degree of CH had significantly greater RMSSD (P=0.047), and high degree of CH showed more sympathetic nervous predominance (P=0.006). Multivariate analysis showed the type and expansion of sympathicotomy were significant factors for CH (P=0.001 and P=0.028, respectively). The neural network (NN) algorithm outperformed and showed a 0.961 accuracy, 0.961 F1 score, 0.961 precision, 0.961 recall, and 0.972 area under the curve (AUC) for classification of hyperhidrosis type. The random forest (RF) model outperformed showed a 0.852 accuracy, 0.853 F1 score, 0.856 precision, 0.852 recall, and 0.914 AUC for prediction of the degree of CH.ConclusionsThe present study showed the machine learning algorithm can classify types and predict CH after sympathicotomy for primary hyperhidrosis with considerable accuracy. Further large-scale studies are needed to validate the findings and provide management guidelines for primary hyperhidrosis.

Project description:BACKGROUND:Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged???9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%). OBJECTIVE:This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294). METHODS:Patients aged???9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (??2 grade improvement), and Dermatology Life Quality Index/children's Dermatology Life Quality Index. RESULTS:Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (>?90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (>?5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were -?71.3% and 8.7?±?6.2/6.2?±?4.9 for Dermatology Life Quality Index/children's Dermatology Life Quality Index. CONCLUSIONS:Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged. TRIAL REGISTRY:Clinicaltrials.gov NCT02553798.

Dataset Information

Treatment of primary axillary hyperhidrosis with botulinum toxin type a: our experience in 50 patients from 2007 to 2010.

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Treatment of primary axillary hyperhidrosis with botulinum toxin type a: our experience in 50 patients from 2007 to 2010.

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