Category: Treatment

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Microwave Thermolysis Reduces Generalized and Social Anxiety in Young Adults With Axillary Hyperhidrosis.

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Microwave Thermolysis Reduces Generalized and Social Anxiety in Young Adults With Axillary Hyperhidrosis.

Lasers Surg Med. 2020 Mar 16;:

Authors: Parrish C, Waldbaum B, Coleman D, Blevins C, Rodgers K, Lee B, Ober C, Hudhud L, Cox S, Griffin C, Chew S, Chen B, Brock M

Abstract
BACKGROUND AND OBJECTIVE: Hyperhidrosis (HH) is associated with impairments in quality of life (QOL) and elevated anxiety. Microwave thermolysis is a newer treatment that reduces sweating, yet effects on QOL and emotional symptoms have not been examined. Two treatment sessions are recommended to achieve 80% amelioration of clinical HH. We hypothesized that microwave thermolysis would reduce sweat severity, improve QOL, and reduce anxiety in young adults suffering from axillary HH in a prospective clinical trial.
STUDY DESIGN/MATERIALS AND METHODS: We enrolled 24 young adults (mean age = 23.57 years, 54% female) with elevated scores on the Hyperhidrosis Disease Severity Scale. All participants received one session of microwave thermolysis, and 83% received two sessions. Participants completed measures of sweat severity, QOL, generalized anxiety, social anxiety, social avoidance, and anxious/depressive mood symptoms at baseline; post-first treatment; and following second treatment.
RESULTS: At baseline, all participants had severe sweating; 87.5% had impaired QOL, 75% had elevated social anxiety, 50% with generalized anxiety, 48% with social avoidance, and 38% with anxious/depressed mood. Paired samples t tests indicated significant improvements from baseline to first procedure, including decreased sweating (t(21) = 5.68, P < 0.001), improved QOL (t(23) = 4.97, P < 0.001), and decreased generalized anxiety (t(23) = 8.11, P < 0.001), social anxiety (t(22) = 4.55, P < 0.001), mood symptoms (t(21) = 3.81, P = 0.001), and social avoidance (t(22) = 3.12, P = 0.005). After second treatment, further improvements were noted in sweating (t(18) = 3.28, P = 0.004) and QOL (t(18) = 3.83, P = 0.003), and a marginal trend for generalized anxiety (t(19) = 1.96, P = 0.064).
CONCLUSION: There were significant improvements in sweat severity, skin-specific QOL, generalized anxiety, social anxiety, anxious/depressive symptoms, and social avoidance. The majority of the psychosocial benefit appears to emerge after one treatment of microwave thermolysis, whereas the level of sweat severity and QOL continued to show further improvements after a second treatment. Results would suggest that although two microwave thermolysis sessions are needed for maximal treatment optimization of axillary HH, patients may experience significant benefits in improving psychosocial functioning after just one session. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

PMID: 32175622 [PubMed – as supplied by publisher]

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Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study.

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Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study.

Pediatr Dermatol. 2020 Mar 08;:

Authors: Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM

Abstract
BACKGROUND/OBJECTIVES: Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients ≥9 years. This post hoc analysis evaluated long-term response (efficacy and safety) in pediatric patients (≥9 to ≤16 years) to GT in the 44-week, open-label extension (NCT02553798) of two, phase 3, double-blind, vehicle-controlled, 4-week trials (NCT02530281, NCT02530294).
METHODS: In the double-blind trials, patients ≥9 years with primary axillary hyperhidrosis were randomized 2:1 to once-daily GT:vehicle. Those who completed the study could receive open-label GT for up to an additional 44 weeks. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (≥2-grade improvement), and Children’s Dermatology Life Quality Index.
RESULTS: Of 43 pediatric patients completing either double-blind trial, 38 (88.4%) entered the open-label extension (age, years: 9 [n = 1], 12 [n = 2], 13 [n = 7], 14 and 15 [n = 9 each], 16 [n = 10]). The safety profile observed was similar to the double-blind trials. Most TEAEs (>95%) were mild/moderate, related to anticholinergic activity, and infrequently led to discontinuation (n = 1/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7 days. Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity. Improvements in efficacy measures were maintained from the double-blind trials.
CONCLUSIONS: Long-term, once-daily GT for up to 48 weeks (4-week double-blind plus 44 week open label) provides a noninvasive, well-tolerated treatment option for pediatric patients with primary axillary hyperhidrosis.

PMID: 32147881 [PubMed – as supplied by publisher]

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Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial.

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Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial.

J Am Acad Dermatol. 2020 Feb 14;:

Authors: Kirsch B, Smith S, Cohen J, DuBois J, Green L, Baumann L, Bhatia N, Pariser D, Liu PY, Chadha D, Walker P

Abstract
BACKGROUND: Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.
OBJECTIVE: To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.
METHODS: A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to one of three doses or vehicle, with daily treatment for 42 days. Coprimary endpoints were the percentage of participants exhibiting ≥1-point improvement in Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax; logistic regression), and change in HDSM-Ax as a continuous measure (ANCOVA). Pair-wise comparisons were one-sided with alpha=0.10.
RESULTS: At end-of-therapy, 70%, 79%, 76% and 54% of participants in the 5%, 10%, 15% and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P<0.05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P≤0.0001). Most treatment-related adverse events were mild or moderate.
LIMITATIONS: Not powered to detect changes in gravimetric sweat production.
CONCLUSION: Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

PMID: 32068049 [PubMed – as supplied by publisher]

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Comparative analysis of the results of videothoracoscopic sympathectomy in the treatment of hyperhidrosis in adolescent patients.

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Comparative analysis of the results of videothoracoscopic sympathectomy in the treatment of hyperhidrosis in adolescent patients.

J Pediatr Surg. 2020 Jan 23;:

Authors: Wolosker N, Faustino CB, de Campos JRM, Kauffman P, Yazbek G, Fernandes PP, Cucato G

Abstract
OBJECTIVE: Several factors that could influence the efficacy and satisfaction of patients after bilateral thoracic sympathectomy (VATS) in the treatment of hyperhidrosis (HH) have been studied, but no studies in the literature have specifically analyzed the effectiveness of treatment and variations in the quality of life of adolescents patients compared to those of adult patients (18-40 years).
METHODS: We retrospectively analyzed 2431 hyperhidrosis patients who underwent bilateral VATS and divided the patients into the following groups: adolescents (472 patients) and adult group (1760 patients). Variables included quality of life prior to surgery, improvement in quality of life after surgery, clinical improvement in sweating, presence of severe compensatory hyperhidrosis and general satisfaction at one month after surgery.
RESULTS: We observed that all surgical patients presented with poor or very poor quality of life before surgery, with similar proportions in both groups. In the postoperative period, we observed improvement in quality of life in more than 90% of the patients, with no significant difference noted between the two groups of patients. We observed that all patients undergoing surgery presented poor or very poor quality of life before surgery; however, the two groups were statistically different. The quality of life of the ADOLESCENT group before surgery was statistically worse than that of the ADULT group. More than 90% of the patients in this series had great clinical improvement in the main hyperhidrosis site, with no significant difference between the two groups. Severe compensatory hyperhidrosis occurred in 23.8% of the patients in this series, with no significant difference between the two groups.
CONCLUSIONS: Adolescent patients benefit just as much as adult patients from VATS performed to treat primary hyperhidrosis, presenting excellent, significant surgical results.
TYPE OF STUDY: Clinical research.
LEVELS OF EVIDENCE: Level III.

PMID: 32063368 [PubMed – as supplied by publisher]

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A comparative study between intradermal botulinum toxin A and fractional microneedle radiofrequency (FMR) for the treatment of primary axillary hyperhidrosis.

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A comparative study between intradermal botulinum toxin A and fractional microneedle radiofrequency (FMR) for the treatment of primary axillary hyperhidrosis.

Lasers Med Sci. 2020 Jan 14;:

Authors: Rummaneethorn P, Chalermchai T

Abstract
Microneedle radiofrequency (FMR) for the treatment of primary axillary hyperhidrosis radiofrequency (RF) technology is a new modality that applied deep heat energy directly affecting the epidermis and dermis. Limiting data about FMR for axillary hyperhidrosis is concerning. To compare clinical efficacy between fractional microneedle radiofrequency and intradermal botulinum toxin type A injection. This study was a randomized, intraindividual split-side comparative study. Twenty female subjects clinically diagnosed of primary axillary hyperhidrosis were enrolled. All subjects randomly assigned to receive either FMR device on one side of axilla or 50 units of intradermal botulinum toxin A on contralateral side of axilla. Treatment with FMR device was scheduled for 2 sessions for 4 weeks apart. After treatment, mean Hyperhidrosis Disease Severity Score (HDSS) of both groups revealed remarkably better reduction from the baseline (p < 000.1). By comparing between the two groups at the endpoint visit (12th week), the botulinum toxin A group had significantly better reduction of mean HDSS score than the microneedle RF group with 1.60 (0.59) versus 2.05 (0.68), respectively (p = 0.0332). At the week-12 visit, the botulinum toxin A group had significantly better participant's satisfaction score by quartile rating scale than the microneedle RF group (2.55 + 0.69 versus 1.70 + 1.03, respectively, p = 0.004). Therefore, the botulinum toxin A group also demonstrated with significantly better improvement for their quality of life by DLQI score at the 12th week than the microneedle RF group (p = 0.013). Intradermal botulinum toxin A had better efficacy than fractional microneedle radiofrequency for the treatment of primary axillary hyperhidrosis.

PMID: 31939036 [PubMed – as supplied by publisher]

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Pressure-and dose-controlled, needle-free, transcutaneous pneumatic injection of botulinum neurotoxin-A for the treatment of primary axillary and palmoplantar hyperhidrosis.

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Pressure-and dose-controlled, needle-free, transcutaneous pneumatic injection of botulinum neurotoxin-A for the treatment of primary axillary and palmoplantar hyperhidrosis.

Skin Res Technol. 2020 Jan 10;:

Authors: Kim HM, Lee MJ, Lee MH, Lee H

Abstract
BACKGROUND: Botulinum neurotoxin (BoNT) effectively downregulates the secretion of eccrine sweat glands in patients with axillary and palmoplantar primary hyperhidrosis (PH).
OBJECTIVE: To demonstrate the efficacy and safety of pressure- and dose-controlled, needle-free, transcutaneous pneumatic injection (TPI) of BoNT-A for treating axillary and palmoplantar PH.
METHODS: Needleless TPI-BoNT-A treatments were delivered on the axillary or palmoplantar skin at a pneumatic pressure of 2.05 bars and an injection volume of 0.08 mL/shot. The efficacy thereof was assessed by evaluating starch-iodine test results and Hyperhidrosis Disease Severity Scale (HDSS) scores.
RESULTS: At baseline, median HDSS scores were 3 (IQR, 3-4) for axillary lesions and 4 (IQR, 3.5-4) for palmoplantar lesions. Median HDSS scores at 1 month after TPI-BoNT-A treatment significantly decreased to 1 (IQR, 1-1.75) for axillary lesions (P < .001) and 1 (IQR, 1-2) for palmoplantar lesions (P < .001). Median global improvement scale scores were 4 (IQR, 3.25-4) for axillary PH and 3 (IQR, 2.5-4) for palmoplantar PH (P > .05). In all patients, pain was tolerable during treatments for both axillary and palmoplantar PH after the application of topical anesthetic cream.
CONCLUSION: Pressure- and dose-controlled, needle-free, BoNT delivery effectively and safely decreased sweating in axillary and palmoplantar skin.

PMID: 31922304 [PubMed – as supplied by publisher]

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Five-year follow-up of patients treated with intra-dermal botulinum toxin for axillary hyperhidrosis.

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Five-year follow-up of patients treated with intra-dermal botulinum toxin for axillary hyperhidrosis.

Ir J Med Sci. 2020 Jan 03;:

Authors: Lynch OE, Aherne T, Gibbons J, Boland MR, Ryan ÉJ, Boyle E, Egan B, Tierney S

Abstract
BACKGROUND: Axillary hyperhidrosis is a common complaint affecting 5% of the general population. It can significantly impact quality of life (QOL) and may be extremely debilitating. Administration of intra-dermal botulinum toxin type-A (Botox) has been proven to be effective in managing axillary hyperhidrosis; however, to date, no long-term data has assessed its efficacy.
AIM: We aim to assess long-term (> 5 years) QOL outcomes in this patient cohort.
METHODS: In this single-centre series, all patients attending for axillary botox, with five or more years of follow-up, were prospectively included. QOL was assessed in all patients using the validated assessment tool, the modified Dermatology Life Quality Index (DLQI). Standard statistical methods were utilised with data reported as mean (± standard deviation). Subgroup analysis utilising previously published departmental data allowed for further assessment of change in QOL over time.
RESULTS: A total of 75 patients (83% female) met the inclusion criteria with 67% completing the DLQI assessment. Follow-up ranged from 5 to 10 years with a mean age of 37.6 years (± 8.82). The mean number of treatments over the study period was 12 (± 3.1). Mean overall post-treatment DLQI score was 1.6 (± 2.01). This represented a significant improvement in patient QOL (p = < 0.0001) associated with long-term botox application. This statistical significance was identified consistently across all components of the DLQI tool.
CONCLUSION: These data suggest that the established early QOL benefits associated with intra-dermal botox administration for AH are sustained in the long term. This benefit was seen across all subsets of the DLQI tool.

PMID: 31898163 [PubMed – as supplied by publisher]

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Thoracoscopic sympathotomy for palmar hyperhidrosis: How young is too young?

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Thoracoscopic sympathotomy for palmar hyperhidrosis: How young is too young?

J Pediatr Surg. 2019 Dec 11;:

Authors: Vasconcelos-Castro S, Soares-Oliveira M, Tuna T, Borges-Dias M

Abstract
BACKGROUND/PURPOSE: Primary hyperhidrosis affects 1%-3% of the general population, with increased incidence in teenagers, having an important impact in the quality of life. This study evaluates the efficacy and patients’ satisfaction after bilateral thoracoscopic sympathotomy.
METHODS: Retrospective analysis of pediatric patients with palmar primary hyperhidrosis that underwent bilateral thoracoscopic sympathotomy over the last eight years. The procedure was performed with 2 ports and simple transection of the sympathetic chain. Pre and postoperative sweating severity was evaluated by telephone interview, using the Hyperhidrosis Disease Severity Scale (HDSS).
RESULTS: 23 patients (19 girls; 15.5 [11-19] years-old) underwent bilateral thoracoscopic sympathotomy. All complained of palmar hyperhidrosis, which resolved in all cases. Compensatory sweating occurred in 47.8% of patients. 21 patients answered the telephone interview: all of them would recommend the surgery to others. Sweating severity improved in all patients, with a mean decrease of 1.95 values of the HDSS from preoperative to postoperative evaluation (p < 0.05). There was neither morbidity nor mortality.
CONCLUSIONS: Bilateral thoracoscopic sympathotomy is a safe and effective treatment for primary palmar hyperhidrosis. Being the first report on pediatric application of HDSS, we conclude that children are very satisfied with the final outcome.
TYPE OF STUDY: Treatment study.
LEVEL OF EVIDENCE: Level III.

PMID: 31870560 [PubMed – as supplied by publisher]