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]

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]

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]

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]

Effects of Direct Current Administration on Hyperhidrosis Disease Severity Scale in Patients with Axillary Hyperhidrosis.

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Effects of Direct Current Administration on Hyperhidrosis Disease Severity Scale in Patients with Axillary Hyperhidrosis.

Biomed Res Int. 2019;2019:3232015

Authors: Şener S, Karakoç Y

Abstract
Background: Focal hyperhidrosis mostly affects the axillae, hands, feet, and face. For the management, several techniques are used. The aim of this study was to investigate the effects of direct current administration on the hyperhidrosis disease severity scale (HDSS) in patients with axillary hyperhidrosis that have various HDSS scores.
Design and Setting: Original article, University Hospital.
Methods: Sixty patients with primary axillary hyperhidrosis were inquired about the HDSS scores and the scores were noted at the onset and at the end of the 10th application. One month after the last session, HDSS scores were also inquired. At the end of 1-month follow-up, the patients whose HDSS scores rose after the 10th session were accepted as nonresponder. For the current delivery, a new iontophoresis application module (Sweat CureR) designed by Dr. Karakoc was used.
Results: Direct current application decreased axillary sweat intensity by 70% at both sides, and lowered the HDSS by about 1.5 degree. Major reduction in sweat intensity was in the patients with low HDSS scores (75%). Negative correlation was found between initial HDSS scores and median values of decreased sweat intensity (r = -0.317, p = 0.022). Minimal temporary side effects including skin irritation and one or more vesicle formation were inspected in 29 patients and, the permanent punctual pigmentation was observed only in one patient.
Conclusions: Decrease in axillary hyperhidrosis is satisfactory for these patients. Since iontophoresis application has beneficial effect and minimal side effects, it should be recommended to the patients before advanced management or surgical techniques.

PMID: 31781610 [PubMed – in process]

[Surgical treatment of primary hyperhidrosis and post-surgical satisfaction. Our 5-year experience].

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[Surgical treatment of primary hyperhidrosis and post-surgical satisfaction. Our 5-year experience].

Cir Pediatr. 2019 Oct 01;32(4):177-180

Authors: Esteva Miró C, Núñez García B, Brun Lozano N, Pérez Gaspar M, Álvarez García N, Betancourth Alvarenga JE, Santiago Martínez S, Jiménez Gómez J

Abstract
INTRODUCTION: Primary palmar hyperhidrosis is a pathology that begins during childhood and can represent a significant reduction in the quality of life of adolescents. The current treatment of choice is thoracoscopic sympathicolysis. The aim of our study is to evaluate the results of surgery in paediatric patients.
MATERIAL AND METHODS: Retrospective study of patients with primary palmar or palmo-axillary hyperhidrosis who underwent thoracoscopic sympathicolysis in our hospital during the last 5 years.
RESULTS: We operated and included in the study 28 patients, 10 men and 18 women. Mean age was 13.8 (8-18) years. Bilateral thoracoscopic sympatholysis was performed with monopolar cautery, between T2-T4 ribs. Mean operative time was 63 minutes and mean hospitalisation time was 1.1 days. The incidence on intraoperative complications was zero. 2 patients presented postoperative subcutaneous emphysema. There were no other postoperative complications. 1 patient presented partial recurrence. In all the rest, sweating completely disappeared and they were totally satisfied with the surgery (96.42%). Temporary compensatory sweating appeared in 57.14% of the cases, a collateral effect that did not change their level of satisfaction.
CONCLUSIONS: Palmar hyperhidrosis can be a major problem for socialization and quality of life for the child or adolescent who suffers it. Thoracoscopic sympatholysis in the pediatric patient is an effective treatment, highly resolutive and with low morbidity. Despite compensatory sweating, patients are highly satisfied with the results of surgical treatment.

PMID: 31626401 [PubMed – in process]

Reduction of Injection Site Pain in the Treatment of Axillary Hyperhidrosis With Botulinum Toxin: A Randomized, Side-by-Side, Comparative Study of Two Injection Patterns.

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Reduction of Injection Site Pain in the Treatment of Axillary Hyperhidrosis With Botulinum Toxin: A Randomized, Side-by-Side, Comparative Study of Two Injection Patterns.

Dermatol Surg. 2019 Oct 04;:

Authors: Awaida CJ, Rayess YA, Jabbour SF, Abouzeid SM, Nasr MW

PMID: 31592920 [PubMed – as supplied by publisher]