Category: Axillary

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Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis

J Dermatol. 2022 Apr 8. doi: 10.1111/1346-8138.16384. Online ahead of print.

ABSTRACT

In 2020, 5% sofpironium bromide (ECCLOCK® ) gel (hereinafter referred to as sofpironium) was approved in Japan for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium demonstrated the efficacy and safety of sofpironium; however, no study has assessed its early efficacy at <6 weeks after starting treatment. Therefore, to assess the earlier effectiveness of sofpironium, we conducted a 2-week, single-center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis. Patients aged ≥20 years and satisfying with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline were eligible for the study. The primary endpoint for the effectiveness was change in the proportion of patients with a HDSS score of 1, 2, 3, or 4 during the 2-week study period. In 80 patients included in the full analysis set (FAS), there were more women than men (93.8% vs. 6.3%), and the mean age (±standard deviation [SD]) was 33.3 ± 9.4 years. In the FAS, the proportion of patients with a HDSS score of 1 or 2 was 55.0% on day 7, and statistically significant changes were observed after day 3 compared to baseline (p < 0.05). Mean HDSS scores (±SD) were significantly decreased from baseline value of 3.5 ± 0.5 to 2.4 ± 0.9 on day 7 (p < 0.001). The median period for sofpironium treatment to achieve a HDSS score of 1 or 2 for a continuous 2 days was 6 days (95% confidence interval, 4-8). Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks. These results suggest that after 1-week treatment with sofpironium for patients with a HDSS score of 3 or 4, approximately 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients.

PMID:35394087 | DOI:10.1111/1346-8138.16384

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Cohort study on 20 years’ experience of bilateral video-assisted thoracic sympathectomy (VATS) for treatment of hyperhidrosis in 2431 patients

Sao Paulo Med J. 2022 Feb 21:S1516-31802022005004202. doi: 10.1590/1516-3180.2021.0078.R1.23072021. Online ahead of print.

ABSTRACT

BACKGROUND: Primary hyperhidrosis is a condition characterized by excessive sweating, inconsistent with the needs for thermoregulation.

OBJECTIVE: To assess the effectiveness and the change in the quality of life of patients undergoing bilateral VATS (video-assisted thoracoscopic sympathectomy) for treatment of hyperhidrosis, in a large case series.

DESIGN AND SETTING: Cohort study conducted in a tertiary hospital specializing in hyperhidrosis located in São Paulo, Brazil.

METHODS: A total of 2,431 patients who underwent surgery consisting of bilateral video-assisted thoracoscopic sympathectomy between January 2000 and February 2017 were retrospectively assessed in an outpatient clinic specializing in hyperhidrosis. The patients underwent clinical and quality of life assessments on two occasions: firstly, prior to surgery, and subsequently, one month after the operation. The presence or absence of compensatory hyperhidrosis (CH) and general satisfaction after the first postoperative month were also evaluated.

RESULTS: All the patients operated had poor or very poor quality of life before surgery. In the postoperative period, an improvement in the quality of life was observed in more than 90% of the patients. Only 10.7% of the patients did not present CH, and severe CH occurred in 22.1% of the patients in this sample.

CONCLUSION: Bilateral VATS is a therapeutic method that decreases the degree of sweating more than 90% of patients with palmar and axillary hyperhidrosis. It improves the quality of life for more than 90% of the patients, at the expense of development of CH in approximately 90% of the patients, but not intensely.

PMID:35195234 | DOI:10.1590/1516-3180.2021.0078.R1.23072021

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A Phase 3, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Neu-BoNT/A in Treatment of Primary Axillary Hyperhidrosis

Aesthetic Plast Surg. 2022 Feb 7. doi: 10.1007/s00266-021-02715-4. Online ahead of print.

ABSTRACT

BACKGROUND: Botulinum toxin type A is widely used to treat primary axillary hyperhidrosis and has proven to be an effective and safe approach. Onabotulinumtoxin A was approved by the FDA as a treatment for primary axillary hyperhidrosis. This study aimed to evaluate the efficacy and safety of Neu-BoNT/A in subjects diagnosed with primary axillary hyperhidrosis.

METHODS: The Hyperhidrosis Disease Severity Scale, gravimetric measurement of sweat, and Global Assessment Scale were analyzed at weeks 4, 8, 12, and 16 to determine the effect of treatment. Adverse events, physical examination, and vital signs were monitored.

RESULTS: Subjects treated with Neu-BoNT/A showed statistically significant improvement by all 3 methods at weeks 4, 8, 12, and 16 (P value = 0.00). There were no severe adverse events or significant changes in vital signs, physical examination, or laboratory tests.

CONCLUSION: Neu-BoNT/A can be effectively and safely used for primary axillary hyperhidrosis.

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:35132458 | DOI:10.1007/s00266-021-02715-4

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Subcutaneous tissue necrosis with fat liquefaction, hematoma, inflammatory mass after microwave-based treatment for axillary hyperhidrosis

J Cosmet Dermatol. 2022 Jan 31. doi: 10.1111/jocd.14820. Online ahead of print.

ABSTRACT

Axillary hyperhidrosis (AH) and bromhidrosis are common complaint in Asians for consultation in dermatology.A microwave-based device has gradually become a first-choice option during this decade because of the safety and efficacy both for axillary hyperhidrosis and osmidrosis. Other complications reported are transient median and ulnar neuropathy, brachial plexus injury with sensory and motor dysfunction. We herein report a rare case of subcutaneous tissue necrosis with fat liquefaction, hematoma that occurred after microwave-based treatment. It took three weeks for both sides to recover completely. The case prompt us that one pass treatment for the same treatment area and cooling to relieve the pain for 24 hours. Appropriate restriction of movement should be emphasized within one month after treatment. Moreover, more caution is needed when bumps enlarged rapidly .

PMID:35100491 | DOI:10.1111/jocd.14820

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Conservative Management of Median Nerve Brachial Plexopathy after Microwave-based MiraDry Treatment for Axillary Hyperhidrosis

Plast Reconstr Surg Glob Open. 2021 Dec 15;9(12):e3992. doi: 10.1097/GOX.0000000000003992. eCollection 2021 Dec.

ABSTRACT

Axillary hyperhidrosis is characterized by excessive sweating of the armpits, which can significantly affect quality of life. A new microwave-based therapy, MiraDry (Miramar labs, Sunnyvale, Calif.), is a promising minimally-invasive treatment option. We report a case of unilateral brachial plexus thermal injury in a thin 19-year-old man treated for axillary hyperhidrosis with the MiraDry system. He initially experienced swelling and pain in the left hand and was prescribed 1 week of methylprednisolone. He then presented 1 week later with induration and swelling of bilateral axillae with swelling of left thumb, left index, and left long fingers, decreased sensation in median nerve distribution of the left hand, and the inability to flex the left index finger DIP joint. EMG showed absent median nerve motor and sensory function, consistent with median nerve plexopathy. He was conservatively managed with close observation and regular occupational hand therapy appointments. At his 12-month follow-up, there was complete return of left pronator teres strength, thumb flexion, and index finger flexion. Decreased sensation remained at the tip of the left index finger. We report the case of median nerve palsy after MiraDry therapy for axillary hyperhidrosis in a thin young man. We recommend using low-energy settings and pre-procedural ultrasound for young, thin patients because of the more superficial course of the brachial plexus within the axilla.

PMID:34926103 | PMC:PMC8673972 | DOI:10.1097/GOX.0000000000003992

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Sofpironium bromide: an investigational agent for the treatment of axillary hyperhidrosis

Expert Opin Investig Drugs. 2021 Dec 10. doi: 10.1080/13543784.2022.2017880. Online ahead of print.

ABSTRACT

INTRODUCTION: In the last years, increased knowledge about pathophysiology of primary hyperhidrosis has led to novel therapeutic advances. Topical and systemic anticholinergic agents have been proven beneficial in reducing sweat production in primary axillary hyperhidrosis (PAH), although their use is limited by the increased likelihood of systemic anticholinergic drug reactions, particularly regarding the systemic agents.

AREAS COVERED: This paper provides an overview of pharmaceutical characteristics, efficacy and safety data from phase II and III clinical trials on sofpironium bromide (SB), a topical anticholinergic agent which has been employed for the treatment of PAH and has already received its first approval in Japan for the treatment of PAH in the form of 5% gel formulation.

EXPERT OPINION: The retrometabolic drug design of topical SB presents distinct advantages, by limiting systemic absorption and therefore development of anticholinergic adverse events. This along with the popularity of the non-greasy gel formulation is expected to increase compliance. However, this therapy still offers a temporary control of PAH, compared to sympathectomy or device-based treatments, such as microwave thermolysis. Hence, physicians should balance the effectiveness against adverse events of each therapeutic modality and use a personalized approach based on patient’s needs.

PMID:34890517 | DOI:10.1080/13543784.2022.2017880

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Compensatory sweating after thoracoscopic sympathectomy for primary focal hyperhidrosis in children: Are there patient-related risk factors?

J Pediatr Surg. 2021 Oct 30:S0022-3468(21)00747-8. doi: 10.1016/j.jpedsurg.2021.10.036. Online ahead of print.

ABSTRACT

INTRODUCTION: Compensatory sweating (CS) is a common complication after thoracoscopic sympathectomy (TS) and is mainly associated with surgical technique. Our aim was to identify potential risk-factors for CS following TS for primary focal hyperhidrosis in children.

METHODS: A retrospective, single-center review of all bilateral TS was performed between 2017 and 2019. Hyperhidrosis disease severity scale was used for pre-operative severity assessment. Post-operative evaluations were performed after three and six months.

RESULTS: More than the 36-month period, 41 patients were submitted to T2-T4 TS, and 25 were females (60.9%). Median age at surgery was 15.5 years. CS was identified at the 3rd month in 17 (41%) children with most in the dorsolumbar region (56%). By the 6th month, there was a significant reduction in CS (41 to 32%, p = 0.02). The probability of resolution of CS by 6 months is about 50% in both the dorsolumbar and abdominal regions. Neither age, gender, body mass index, family history, or concomitant illnesses seemed to influence CS (p > 0.05). Axillary hyperhidrosis appears to be associated with the development of dorsolumbar CS (p = 0.037).

CONCLUSION: Thoracoscopic sympathectomy for PFH is a safe and effective procedure, but compensatory sweating can be a common and debilitating side effect. Age, gender, and body mass index do not appear to influence CS. Axillary hyperhidrosis may be related to the development of dorsolumbar CS.

LEVEL OF EVIDENCE: III.

PMID:34815104 | DOI:10.1016/j.jpedsurg.2021.10.036

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Topical glycopyrronium tosylate in Japanese patients with primary axillary hyperhidrosis: A randomized, double-blind, vehicle-controlled study

J Dermatol. 2021 Oct 11. doi: 10.1111/1346-8138.16188. Online ahead of print.

ABSTRACT

Glycopyrronium tosylate cloth, an anticholinergic drug, has been approved for the topical treatment of primary axillary hyperhidrosis in the USA, but its effects in Japanese patients have not been previously investigated. This 4-week, randomized, double-blind, vehicle-controlled, multicenter study was conducted to evaluate the efficacy and safety of glycopyrronium tosylate cloth for primary axillary hyperhidrosis patients in Japan. Eligible patients, who were ≥9 years of age and had primary axillary hyperhidrosis ≥6 months, with gravimetrically-measured sweat production ≥50 mg/5 min, and Hyperhidrosis Disease Severity Scale ≥3 (moderate) were randomized 1:1:1 to once daily topical glycopyrronium tosylate 3.75%, 2.5%, or vehicle. Overall, 497 patients (163 in the glycopyrronium tosylate 3.75% group, 168 in the glycopyrronium tosylate 2.5% group, and 166 in the vehicle group, hereinafter in this order) were randomized. Statistically higher proportions of patients in the glycopyrronium tosylate groups achieved ≥2-point improvement in Hyperhidrosis Disease Severity Scale and ≥50% reduction in sweat production from baseline versus vehicle at week 4 (51.6%, 41.1%, and 16.4%, respectively; p < 0.001 in both cases). Higher responder rates in the glycopyrronium tosylate groups compared with the vehicle group occurred as early as week 1. The most common treatment-emergent adverse events in patients treated with glycopyrronium tosylate were photophobia, mydriasis, thirst, and dysuria. Most treatment-emergent adverse events were mild as determined by the investigators. The incidence of treatment-emergent adverse events leading to treatment modification was low in the three groups. The 4-week use of topical glycopyrronium tosylate improved the patient-reported outcome measure Hyperhidrosis Disease Severity Scale and objectively-evaluated sweat production with a favorable benefit/risk profile.

PMID:34636057 | DOI:10.1111/1346-8138.16188