Category: Hyperhidrosis

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A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

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A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

J Dermatol. 2021 Jan 07;:

Authors: Yokozeki H, Fujimoto T, Abe Y, Igarashi M, Ishikoh A, Omi T, Kanda H, Kitahara H, Kinoshita M, Nakasu I, Hattori N, Horiuchi Y, Maruyama R, Mizutani H, Murakami Y, Watanabe C, Kume A, Hanafusa T, Hamaguchi M, Yoshioka A, Egami Y, Matsuo K, Matsuda T, Akamatsu M, Yorozuya T, Takayama S

Abstract
A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI-4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end-point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6-week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0 years. The proportion of patients who achieved the primary efficacy end-point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02-28.93) between these two groups (P = 0.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.

PMID: 33410265 [PubMed – as supplied by publisher]

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Does the Sweating Severity of Primary Hyperhidrosis Sites Affect Post-Sympathotomy Results?

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Does the Sweating Severity of Primary Hyperhidrosis Sites Affect Post-Sympathotomy Results?

Thorac Cardiovasc Surg. 2020 Dec 24;:

Authors: Çınar HU, Çelik B

Abstract
BACKGROUND:  Improvement in quality of life (QOL) and patient satisfaction after endoscopic thoracic sympathotomy (ETS) in patients with primary hyperhidrosis may be affected by various factors. We examined whether the preoperative sweating severity of primary hyperhidrosis sites affects postoperative results.
METHODS:  The records of 112 patients who underwent bilateral ETS were reviewed retrospectively. The patients were divided into three groups according to the sweating severity score obtained from all primary hyperhidrosis sites (primary hyperhidrosis severity score [PHSS]) and analyzed comparatively. Group A (PHSS = 1-4) included 22 patients, Group B (PHSS = 5-8) 36 patients, and Group C (PHSS ≥ 9) 54 patients. Outcome measures included QOL prior to surgery, improvement in QOL after surgery, degree of clinical improvement, presence, severity, localization, and site number of reflex sweating (RS) and general patient satisfaction after 6 months of surgery.
RESULTS:  The preoperative QOL of patients with higher PHSS (groups B, C) was worse than other patients (group A). More than 91% of all patients had any level improvement in QOL, and over 96% had slight or great clinical improvement. RS developed in 80% of the patients, mostly in the back, very severe in 8%, and in median two different body areas. The overall patient satisfaction rate was more than 95%. There was no significant difference between the three groups in terms of all postoperative results.
CONCLUSION:  Preoperative sweating severity of primary hyperhidrosis sites does not affect post-sympathotomy results. Surgeons should not be worried when deciding upon surgery, even in patients with high sweating severity.

PMID: 33368108 [PubMed – as supplied by publisher]

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CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects.

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CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects.

Rofo. 2020 Dec 21;:

Authors: Andresen JR, Scheer F, Schlöricke E, Andresen R

Abstract
PURPOSE:  The objective of the present study was to evaluate the benefit of a thoracic, computed tomography-guided sympathicolysis (CTSy) in patients with primary, focal hyperhidrosis of the hands. In addition, the influence of the amount and distribution of the administered sympathicolytic agent was to be assessed.
PATIENTS AND METHODS:  Retrospectively, 78 patients [13 (16.7 %) men, mean age 31.2 ± 9 years and 65 (83.3 %) women, mean age 34.2 ± 12 years], who had been treated using CTSy, were included in the study. The indication for treatment was primary focal palmar hyperhidrosis grade II and grade III after exhaustion of all conservative treatment options and a continued high level of suffering. CTSy was performed after establishing the entry plane at the level of the intervertebral space T2 / T3 via a dorsolateral approach using a 22-G coaxial needle. On average 5 (2-10) ml of a sympathicolytic mixture (10 ml consisting of 8 ml 96 % alcohol, 1.6 ml 0.5 % Carbostesin and 0.4 ml 0.9 % NaCl solution, with added amounts of contrast medium) were instilled. The volume of distribution of the sympathicolytic agent was determined in craniocaudal direction using CT images. The patients evaluated their sense of discomfort preinterventionally, 2 days postinterventionally, and 6 and 12 months after the intervention, on the basis of a Dermatology life Quality Index (DLQI) as well as the side effects that occurred.
RESULTS:  The technical success rate of CTSy was 100 %. No major complications occurred. The interventions performed led to a significant reduction (p < 0.001) in the preinterventional sense of discomfort 2 days, 6 and 12 months after CTSy. As the most common side effect, compensatory sweating was reported by 16/78 (20.5 %) of the patients over the further course. In all of these patients, the volume of sympathicolytic agent administered was below 5 ml. In no case did the sympathicolytic agent extend caudally beyond the base plate of Th 3. No compensatory sweating of the back was observed in 5/78 (6.4 %) patients; here the sympathicolytic volume was above 5 ml and extended significantly caudally below the baseplate of T3.Transient miosis and ptosis was found in 8/78 (10.3 %) patients. In all of these patients, the volume of sympathicolytic agent administered was above 5 ml and it extended markedly cranially beyond the upper plate of T2. A mild to moderate recurrent sweating developed in 35/78 (44.9 %) patients, which was more marked if the volume of sympathicolytic administered was below 5 ml and slightly more pronounced on the left than on the right. Given a high level of satisfaction overall, 71/78 (91.0 %) patients said that they would undergo the intervention again.
CONCLUSION:  For patients with primary, focal palmar hyperhidrosis CTSy represents a therapeutic option that offers good benefit and has few side effects. The amount and spatial distribution of the sympathicolytic agent has an influence on the therapeutic outcome and the side effects.
KEY POINTS: · CT-assisted thoracic sympathicolysis is a minimally invasive, low-complication therapy for treatment of severe forms of primary hyperhidrosis palmaris.. · CT-assisted thoracic sympathicolysis can usually be performed on an outpatient basis.. · The quantity and local distribution of the sympathicolytic agent has an influence on the therapeutic outcome and the side effects..
CITATION FORMAT: · Andresen J, Scheer F, Schlöricke E et al. CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects. Fortschr Röntgenstr 2020; DOI: 10.1055/a-1299-2098.

PMID: 33348382 [PubMed – as supplied by publisher]

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Fractional CO2 Laser for Transcutaneous Drug Delivery of Onabotulinum Toxin in Palmar Hyperhidrosis.

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Fractional CO2 Laser for Transcutaneous Drug Delivery of Onabotulinum Toxin in Palmar Hyperhidrosis.

Dermatol Surg. 2020 Dec 15;Publish Ahead of Print:

Authors: Agamia NF, Sobhy N, Abd-Elraouf A, Tawfik A

Abstract
BACKGROUND: Palmar hyperhidrosis is a common disorder of excessive sweating due to over-stimulation of cholinergic receptors on eccrine glands.
OBJECTIVE: To compare the efficacy of laser-assisted drug delivery of onabotulinum toxin A (BoNTA) and intradermal BoNTA injections in the management of palmar hyperhidrosis.
PATIENTS AND METHODS: This intrapatient comparative study was conducted on 30 adult patients with idiopathic palmar hyperhidrosis. The palms of the patients were divided into 2 groups. Group 1 was treated with intradermal injections of 50 units of BoNTA, whereas Group 2 was subjected to laser-assisted transcutaneous BoNTA delivery using fractional CO2 laser at different doses (25, 50, and 75 units). Each treatment modality was evaluated using the iodine starch test, hyperhidrosis disease severity scale, and gravimetric scoring.
RESULTS: Delivery of 75 units of BoNTA to the dermis on the right-sided palms assisted by fractional CO2 laser was clinically equivalent to 50 units of injection on the left side. Pain intensity was significantly higher on the injected side than on the other side.
CONCLUSION: Laser-assisted drug delivery of botulinum toxin can be considered an effective and safe alternative for treatment of palmar hyperhidrosis with minimal side effects and complications.

PMID: 33337732 [PubMed – as supplied by publisher]

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Efficacy of Photodynamic Therapy for Treatment of Primary Palmar Hyperhidrosis.

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Efficacy of Photodynamic Therapy for Treatment of Primary Palmar Hyperhidrosis.

Dermatol Ther. 2020 Dec 10;:

Authors: Shabaik AH, Shaheen MA, Soltan MY

Abstract
BACKGROUND: Palmar hyperhidrosis represents a condition with a significant cosmetic and psychological burden. Various treatment modalities are available; however, searching for newer options to meet patients’ needs and expectations is encouraged.
AIM: The study aimed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of primary palmar hyperhidrosis. Two different photosensitizers for PDT were evaluated: eosin Y, and methylene blue. The study focused on the clinical efficacy, patient’s satisfaction, and the time & number of sessions needed to achieve a satisfactory response.
METHODS: Twenty patients with primary palmar hyperhidrosis were enrolled in a single-center clinical study. Patients were treated with PDT for a maximum of eight sessions. Two photosensitizers were tested: eosin Y, and methylene blue for the right and left hand, respectively. The Hyperhidrosis disease severity scale (HDSS), and Sweating Intensity Visual Scale of Minor’s test were used for assessment.
RESULTS: Photodynamic therapy effectively reduced the severity scores of hyperhidrosis with comparable results between the two photosensitizers. The treatment effect was maintained up to three months after the last procedure.
CONCLUSION: Photodynamic therapy is a good treatment option for primary palmar hyperhidrosis with results maintainable for three months after the treatment end.

PMID: 33301218 [PubMed – as supplied by publisher]

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Craniofacial hyperhidrosis: clinical characteristics and response to treatment in a cohort of 97 patients treated with oral oxybutynin.

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Craniofacial hyperhidrosis: clinical characteristics and response to treatment in a cohort of 97 patients treated with oral oxybutynin.

Dermatol Ther. 2020 Dec 10;:

Authors: García-Souto F, Del Boz J, Colmenero-Sendra M, Polo-Padillo J

Abstract
The term craniofacial hyperhidrosis (HH) refers to HH that affects the face and/or scalp. Few studies have focused on this specific location, and even fewer distinguish between the two areas. Our study aims are to describe the clinical characteristics of patients with craniofacial HH, specifying whether the condition affects the scalp, face or both, and to compare these cases with those recorded at other locations. As secondary objectives, we determine the effectiveness and adverse effects of oral oxybutynin (OOx), and assess patients’ adherence to treatment. This prospective observational study was carried out with respect to the period 2007-2019. All patients diagnosed with HH of the scalp and/or face and who were treated with OOx at our HH unit were included in the study group. Of 292 patients treated with OOx, 97 (33.2%) had craniofacial HH. Of these, four (4.1%) presented HH exclusively on the scalp, 56 (57.7%) exclusively on the face and 37 (38.1%) in both locations. The patients in the latter category (compared to those with exclusively facial HH) were significantly older than the others, had a later onset of HH, a greater frequency of secondary HH, less simultaneous involvement of the classical areas of primary focal HH (the palms, soles and armpits) and greater generalised HH and of the trunk. No significant differences were observed between the three locations (face, scalp or both) regarding the efficacy and side effects of OOx. The patients with exclusively facial HH presented greater adherence to treatment. This article is protected by copyright. All rights reserved.

PMID: 33301207 [PubMed – as supplied by publisher]

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Heart rate variability as a potential diagnostic tool to predict compensatory hyperhidrosis after sympathectomy in patients with primary focal hyperhidrosis.

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Heart rate variability as a potential diagnostic tool to predict compensatory hyperhidrosis after sympathectomy in patients with primary focal hyperhidrosis.

J Thorac Dis. 2020 Nov;12(11):6789-6796

Authors: Jeong SC, Kim JJ, Kim YH, Kim IS, Han JW, Moon SW

Abstract
Background: Primary focal hyperhidrosis (PFH) is associated with autonomic nervous activity, and studies investigating this association in patients with PFH are very important. Heart rate variability (HRV) is a simple and noninvasive electrocardiographic test showing activity and balance in the autonomic nervous system, which consists of sympathetic and parasympathetic components. The aims of this study are to investigate associations between autonomic nervous activity and hyperhidrosis characteristics using HRV and to investigate the association between HRV findings and compensatory hyperhidrosis (CH) after sympathectomy.
Methods: From March 2017 to March 2020, 105 subjects with PFH who underwent preoperative HRV tests and sympathectomy were analyzed. All subjects underwent bilateral thoracoscopic sympathectomy. T2 sympathectomy was conducted for craniofacial hyperhidrosis, and T3 sympathectomy was conducted for palmar hyperhidrosis. The following HRV parameters chosen to investigate the association between hyperhidrosis and autonomic nervous activity were measured by time and frequency domain spectral analysis: (I) time domain: standard deviation of normal-to-normal interval (SDNN) and square root of mean squared differences of successive normal-to-normal intervals (RMSSD), (II) frequency domain: total power (TP) of power spectral density, very low frequency (VLF), low frequency (LF), and high frequency (HF). HRV parameters were analyzed according to hyperhidrosis type (craniofacial vs. palmar type), sweat reduction, and CH after sympathectomy. In addition, the independent HRV parameters influencing CH after sympathectomy were investigated with multivariate analysis.
Results: Craniofacial hyperhidrosis was significantly more prevalent in the old age group (P<0.001). Sweat reduction after sympathectomy was significantly more prominent in palmar hyperhidrosis (P=0.037), and CH after sympathectomy was more prominent in craniofacial hyperhidrosis (P<0.001). Palmar type patients exhibited significantly larger SDNN, RMSSD, TP, LF, and HF than craniofacial type patients (all P<0.001). There were no significant differences in any HRV parameters according to sweat reduction after sympathectomy. Low-degree CH was associated with significantly larger SDNN, RMSSD, TP, LF, and HF than high-degree CH (P<0.001, P<0.001, P=0.002, P=0.001, and P<0.001, respectively). Multivariate analysis showed that HF and age group were associated with CH after sympathectomy (P=0.007 and P=0.010, respectively).
Conclusions: This study shows that HRV can provide useful insight into the pathophysiology of PFH and enhance preoperative risk stratification of CH. Large-scale, prospective studies are required to determine the predictive value of HRV in patients at risk for subsequent CH after sympathectomy.

PMID: 33282380 [PubMed]

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VATS sympathectomy for hyperhidrosis.

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VATS sympathectomy for hyperhidrosis.

Multimed Man Cardiothorac Surg. 2020 Nov 11;2020:

Authors: Sastre I, España M, Ceballos RJ, Bustos MEF

Abstract
Excessive sweating in the hands, feet, and armpits is a difficult problem for people who suffer from it and is an increasingly frequent reason for consulting a thoracic surgeon. The existing medical treatments are only palliative, so primary hyperhidrosis is a definite indication for thoracic sympathectomy. This video tutorial shows in detail the 2-port videothoracoscopic surgical technique performed by our surgical team.

PMID: 33263362 [PubMed – in process]

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[Hyperhidrosis from diagnosis to management].

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[Hyperhidrosis from diagnosis to management].

Rev Med Interne. 2020 Nov 28;:

Authors: Aubignat M

Abstract
Hyperhidrosis is defined as uncontrollable, excessive and unpredictable sweating that exceeds the needs related to thermoregulation. It preferentially affects axillary, palms, soles and face but can affect any part of the body. This ostensibly benign symptom can have a major negative impact on quality of life sometimes leading to isolation and depression. Moreover, in some cases hyperhidrosis can be secondary to an underlying pathology sometimes malignant which must be identified quickly. Consequently, each doctor should be able to develop a diagnostic and therapeutic approach for this relatively frequent and probably underdiagnosed and undertreated reason for consultation. In this review, we focus on diagnosis hyperhidrosis and its management.

PMID: 33261887 [PubMed – as supplied by publisher]