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

Setting research priorities for management and treatment of hyperhidrosis: the results of the James Lind Alliance Priority Setting Partnership

Clin Exp Dermatol. 2022 Feb 5. doi: 10.1111/ced.15122. Online ahead of print.

ABSTRACT

BACKGROUND: Hyperhidrosis is a common skin condition characterised by excessive sweating, which can negatively impact on quality of life. It is under-researched compared with other conditions of similar prevalence.

OBJECTIVE: To generate a top ten list of research priorities for the treatment and management of hyperhidrosis, with equal input from people with hyperhidrosis and healthcare professionals.

METHODS: A priority setting partnership was established and processes from the James Lind Alliance Handbook were followed. An online survey asked participants what questions they would like research to answer. These questions were grouped into ‘indicative questions’ which were ranked in a second survey of 45 indicative questions. The top 23 questions were taken to a final workshop event attended by key stakeholders, and ranked to generate the top ten list of research priorities.

RESULTS: There were 592 questions submitted by 268 respondents for the first survey. For the second survey, 286 participants ranked the indicative questions in order of priority. At the final workshop, the top ten list was generated. The top three priorities were; Are there any safe and effective permanent solutions for hyperhidrosis?, what is the most effective and safe oral treatment (drugs taken by mouth) for hyperhidrosis? and what are the most effective and safe ways to reduce sweating in particular areas of the body?

CONCLUSIONS: There are many unanswered research questions that people with hyperhidrosis and healthcare professionals would like to see answered. The results from this PSP will help to ensure future research funding can be directed to these areas of priority.

PMID:35124833 | DOI:10.1111/ced.15122

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

How to Prevent, Reduce, and Treat Severe Post Sympathetic Chain Compensatory Hyperhidrosis: 2021 State of the Art

Front Surg. 2022 Jan 3;8:814916. doi: 10.3389/fsurg.2021.814916. eCollection 2021.

ABSTRACT

The role of thoracic surgery in the management of hyperhidrosis is well-known and thoracoscopic sympathetic interruption is commonly accepted as being the most effective treatment. However, some concerns still remain regarding the potential to develop compensatory hyperidrosis (CH), the most troublesome and frequent side effect after surgery and its management. Compensatory hyperidrosis prevention may be achieved by identifying subjects at higher risk and/or targeting nerve interruption level on the base of single patient characteristics gathered during the preoperative survey. Furthermore, the surgical treatment may consist of different techniques aimed at reversing the effects of previous sympathetic interruption. To predict CH after sympathectomy, the most interesting proposals in recent literature are a temporary thoracoscopic sympathetic block and the introduction of new and targeted preoperative surveys. If the role of nerve clipping technique vs. the definitive cutting is still intensely under debated, new approaches have been recently proposed to reduce the incidence of CH. In particular, extended sympathicotomy has been described as an alternative to overcome severe forms. Last, among the techniques developed to reverse sympathetic interruption effect, diffuse sympathicotomy (DS) and microsurgical sympathetic trunk reconstruction represent advances in this field. An all-round review of these topics is strongly needed. Our aim is to cover all the above issues point by point. Although sympathectomy represents a small part of thoracic surgery, we believe that it is worthy of interest because of the profound effect that complications for a benign condition can have on patients.

PMID:35047551 | PMC:PMC8763307 | DOI:10.3389/fsurg.2021.814916

Long-term follow-up in quality of life before and after endoscopic thoracic sympathicotomy in 367 patients with palmar hyperhidrosis

Ann Palliat Med. 2022 Jan 10:apm-21-2860. doi: 10.21037/apm-21-2860. Online ahead of print.

ABSTRACT

BACKGROUND: Palmar hyperhidrosis (PH) hinders daily activities and deteriorates quality of life (QOL). Endoscopic thoracic sympathicotomy (ETS) is safe and efficient as the gold standard treatment for PH. So far, the long-term change of QOL after surgery has not been fully characterized, which is important to evaluate clinical benefits and helped to identify the true beneficiaries. In the current study, we aimed to investigate the long-term outcome of ETS by comparing their preoperative QOL with a follow-up QOL.

METHODS: This study enrolled 367 patients with PH who underwent ETS between March 2018 and March 2019. All patients were surveyed by a web-based questionnaire adapted from de Campos Quality-of-life Questionnaire for Evaluation of Hyperhidrosis, and compared to their preoperative results.

RESULTS: After a median follow-up of 14 months [interquartile range (IQR), 9-21 months], improvement in QOL was reported in 90.7% of patients. Compared to preoperative QOL [median (Md) =40, IQR, 37-45], postoperative QOL was significantly improved (Md =20, IQR, 13-23; P<0.001). A higher QOL score was noticed in patients with severer PH at diagnosis, whereas no significant difference was observed among postoperative QOL regarding the severity of PH. Subclinical compensatory hyperhidrosis (CH) occurred in 94.6% of post-ETS cases after long-term follow-up. The score of postoperative QOL was significantly positively correlated to the severity of CH (rs=0.14; P=0.009).

CONCLUSIONS: Improvement in QOL sustained for a long-term period after receiving ETS for PH. Almost all patients developed subclinical CH on other body sites in the long run, with an impairment in QOL correlating with the severity of CH. Further investigations on the developing patterns of CH and clinical coping strategy are warranted to improve the long-term outcome of ETS.

PMID:35016525 | DOI:10.21037/apm-21-2860

Knowledge of surgical management of hyperhidrosis among primary care physicians and the general public

Interact Cardiovasc Thorac Surg. 2022 Jan 7:ivab371. doi: 10.1093/icvts/ivab371. Online ahead of print.

ABSTRACT

OBJECTIVES: Our study examined attitudes towards initial management of hyperhidrosis, willingness to seek surgical consultation and knowledge of an appropriate specialty for surgical consultation among primary care physicians and the general public.

METHODS: An online survey was sent to all general medicine and paediatric residents and attending physicians at our academic medical centre. Participants were provided with a clinical scenario of palmar hyperhidrosis and were asked to select among initial management options and preferences for surgical consultation if patients failed non-operative management. To assess the general public’s perspective, workers from Amazon Mechanical Turk were recruited to complete a similar survey.

RESULTS: The majority of primary care physicians (31/53; 58%) would prescribe topical aluminium chloride for palmar hyperhidrosis, whereas 28 of 53 (53%) would refer such patients to dermatology. Twenty-three of 53 (43%) physicians would refer such patients to surgery if conservative management failed: 18 (78%) to plastic surgery, 4 (17%) to general surgery and none to thoracic surgery. The majority of workers (130/205; 63.4%) would seek primary care treatment for palmar hyperhidrosis. Over half (113/205; 55%) would seek surgical consultation if conservative management failed: 65 (58%) general surgery and 15 (13%) neurosurgery, with only 8 (7%) selecting thoracic surgery.

CONCLUSIONS: Neither primary care physicians nor the general public recognize the role of thoracic surgeons in managing primary focal hyperhidrosis when medical management fails. Education of physicians and the public may mitigate this knowledge gap.

PMID:35015865 | DOI:10.1093/icvts/ivab371

Comparison of 10 versus 20 sessions tap water iontophoresis efficacy in the treatment of palmoplantar hyperhidrosis

J Cosmet Dermatol. 2022 Jan 4. doi: 10.1111/jocd.14723. Online ahead of print.

ABSTRACT

BACKGROUND: Tap water iontophoresis (TWI) is an effective treatment option for palmoplantar hyperhidrosis (HH). However, the optimal number and frequency of TWI sessions to control profuse sweating are unclear.

OBJECTIVE: To compare the efficacy of 10 and 20 sessions of TWI in patients with palmoplantar HH and determine the adequate number of sessions to achieve a favorable clinical response.

METHODS: Eighty patients treated with TWI for palmoplantar HH were included. The alteration in sweating intensity considering the mean value of gravimetric measurement and mean visual analog scale (VAS) scores after the 10th and 20th session of TWI were calculated. The difference between performing 10 and 20 sessions of TWI in providing improvement of HH was analyzed. We also conducted a telephone-based inquiry to determine the patients’ outcome.

RESULTS: The reduction in sweating intensity was significant both after the 10th (p < 0.001) and 20th (p < 0.001) sessions when compared with the basal level considering gravimetry and VAS. When the mean sweating intensity after the 10th and 20th sessions were compared, no difference was observed gravimetrically (p = 0.03); the difference between the mean score of VAS after the 10th and 20th sessions (p < 0.001) was significant. Eleven and nine patients not considering a maintenance or an alternative treatment had lower and same sweating intensity as compared with the baseline, respectively.

CONCLUSION: Ten TWI sessions within two weeks for managing palmoplantar HH are adequate to achieve a clinical response. However, the patients are more satisfied when they receive 20 sessions instead of 10 sessions of TWI.

PMID:34982502 | DOI:10.1111/jocd.14723

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

Control of Diabetic Gustatory Hyperhidrosis With Topical 20% Aluminum Chloride Hexahydrate

J Drugs Dermatol. 2021 Dec 1;20(12):1359-1360. doi: 10.36849/jdd.5755.

ABSTRACT

Diabetic gustatory hyperhidrosis is a late sequela of diabetes and can have profound consequences. We report a case of diabetic gustatory hyperhidrosis controlled with topical aluminum chloride hexahydrate and support this as a first-line treatment. Aluminum chloride hexahydrate is a safe, effective, inexpensive and commercially available treatment.

PMID:34898156 | DOI:10.36849/jdd.5755

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