Category: Hyperhidrosis

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A phase III, 52-week, open-label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis

J Dermatol. 2021 May 26. doi: 10.1111/1346-8138.15927. Online ahead of print.

ABSTRACT

A long-term study was conducted in Japanese patients with primary axillary hyperhidrosis who completed the preceding 6-week phase III, confirmatory study of 5% sofpironium bromide gel (hereinafter referred to as sofpironium) to evaluate the safety and efficacy of 52-week treatment with sofpironium. In the long-term study, 185 patients who completed the confirmatory study (94 and 91 patients in the vehicle and sofpironium groups, respectively) started to receive sofpironium (switching and extension groups, respectively), and all these patients were included in both the full analysis set (FAS) and the safety analysis set (SAF). In the FAS, there were more females than males (73.0% vs. 27.0%), and median age was 38.0 years. A total of 161 patients (86 and 75 patients in the switching and extension groups, respectively) completed the study at week 52. The proportions of patients with hyperhidrosis disease severity score of 1 or 2 and a 50% or more reduction in total gravimetric weight of sweat were 57.4% in the switching group and 58.2% in the extension group at week 52. The proportions of patients who achieved this efficacy end-point in the long-term study were similar to that (53.9%) in the sofpironium group in the confirmatory study. In the SAF, the incidences of adverse events (AEs) were 80.9% in the switching group and 83.5% in the extension group, and the incidences of adverse drug reactions were 39.4% and 45.1%, respectively. AEs that occurred in at least 20% of patients in both treatment groups were application site dermatitis (25.5% and 33.0%, respectively) and nasopharyngitis (31.9% and 23.1%, respectively). Reported AEs were generally mild, and there were no deaths. Serious AEs occurred in three patients, but none were considered related to the study drug. In this study, the efficacy of sofpironium was maintained during 52-week treatment, and no new safety risk was observed.

PMID:34041788 | DOI:10.1111/1346-8138.15927

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Pathological Changes in Axillary Hyperhidrosis and Axillary Osmidrosis Induced by Microwave Treatment: Comparison of Single- and Double-Pass Irradiation

Lasers Surg Med. 2021 May 26. doi: 10.1002/lsm.23412. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: To analyze histopathological changes and degree of damage to the axillary tissue due to single- and double-pass irradiation therapy using a microwave energy-based device. STUDY DESIGN/MATERIALS AND METHODS: We included 15 axillary hyperhidrosis and axillary osmidrosis patients who received microwave irradiation therapy between March 2017 and March 2019. Ten patients underwent single-pass irradiation and five underwent double-pass irradiation, after which skin samples were collected from the right and left axillae for pathological analysis. Samples were taken in a consistent manner from Patient 6 onwards and a comparative study of five single-pass and five double-pass patients was conducted (n = 10).

RESULTS: Histopathological analysis showed destruction and fibrosis in addition to necrosis and damage to the adipose tissue in apocrine and eccrine sweat glands. In the superficial microvasculature, blood vessel wall damage and thrombus formation were observed as well as damage in the hair follicles and hair bulbs. No obvious damage was observed in the epidermis and nerves. The amount of damage to sweat glands was higher in patients undergoing double-pass instead of single-pass irradiation.

CONCLUSION: From a histopathological point of view, microwave energy-based irradiation therapy can be considered efficient, as there was no damage to epidermis and nerves and favorable destruction of apocrine and eccrine glands. As the amount of damaged sweat glands was higher after double-pass irradiation, it can be considered more effective than single-pass irradiation. Lasers Surg. Med. © 2021 Wiley Periodicals LLC.

PMID:34036606 | DOI:10.1002/lsm.23412

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Comparison of EQ-5D-3L and metabolic components between patients with hyperhidrosis and the general population: a propensity score matching analysis

Qual Life Res. 2021 May 11. doi: 10.1007/s11136-021-02856-8. Online ahead of print.

ABSTRACT

PURPOSE: It is important to understand the characteristics of patients with hyperhidrosis, which are different from the general population, for treating hyperhidrosis. Sympathetic overactivity, which might play an important role in hyperhidrosis, can contribute to metabolic diseases and the decreased quality of life (QoL). We compared the metabolic components and health-related QoL between patients with hyperhidrosis and the general population.

METHODS: We conducted a case-control study and compared the characteristics of the patients (N = 196) with hyperhidrosis and propensity score-matched controls (N = 196) selected from the Korean National Health and Nutrition Examination Survey. Metabolic components and EQ-5D-3L (EQ-5D) index were compared using a two-way mixed analysis of covariance after adjusting for confounders.

RESULTS: Patients with hyperhidrosis had significantly higher waist circumference (estimated mean values ± SD for patients and the control group, 85.5 ± 10.8 cm vs 81.3 ± 10.3 cm, p < 0.001), blood pressure (SBP, 121.1 ± 16.9 vs 111.7 ± 10.3, p < 0.001 AND DBP, 77.5 ± 12.8 vs 73.6 ± 8.6, p < 0.001, respectively), fasting glucose (97.1 ± 11.3 vs 91.5 ± 9.2, p < 0.001), and the number of components of metabolic syndrome (1.4 ± 1.3 vs 1.0 ± 1.2, p = 0.002), and significantly lower estimated glomerular filtration rate (144.3 ± 53.2 vs 158.3 ± 55.7, p = 0.002) and EQ-5D values (estimated mean values (standard error) for patients and the control group, 0.92 (0.01) vs 0.97 (0.01), p < 0.001) compared to the control group after adjustment.

CONCLUSION: The patients with hyperhidrosis had more central obesity and unfavorable metabolic parameters and a lower EQ-5D index compared with the general population, emphasizing clinical importance of hyperhidrosis to be cured in aspect of metabolic components as well as patients’ QOL.

PMID:33974220 | DOI:10.1007/s11136-021-02856-8

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Paroxysmal localized Hyperhidrosis, a case-report: When excessive sweating occurs in combination with severe headaches

Cephalalgia. 2021 May 2:3331024211006843. doi: 10.1177/03331024211006843. Online ahead of print.

ABSTRACT

BACKGROUND: Paroxysmal localized hyperhidrosis is a rare disorder of the central autonomic nervous system. No association between paroxysmal hyperhidrosis and severe headache has been previously described in literature.Case description: A 65-year-old woman with idiopathic paroxysmal localized hyperhidrosis combined with severe holocranial headache attacks is described in this case report. Extensive diagnostic testing by means of laboratory examinations, 24-hour urinalyses, chest X-ray, abdominal ultrasound and computed tomography scans, and brain and spinal cord magnetic resonance imaging could not identify an underlying disorder. A diagnosis of idiopathic paroxysmal localized hyperhidrosis was made, and the patient was successfully treated with clonidine 0.075 mg three times a day, without any side effects.

CONCLUSION: Paroxysmal localized hyperhidrosis is a rare central autonomic nervous system disorder that can occur in combination with severe headache. Both the headache and paroxysmal hyperhidrosis complaints were treated effectively with clonidine in the patient described in this case-report.

PMID:33938252 | DOI:10.1177/03331024211006843

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Management of Primary Focal Hyperhidrosis: An Algorithmic Approach

J Drugs Dermatol. 2021 May 1;20(5):523-528. doi: 10.36849/JDD.5774.

ABSTRACT

Hyperhidrosis (HH) is defined as perspiration beyond the level required to maintain temperature regulation. HH affects nearly 4.8% of the population in the United States. It can have a great impact on patient&rsquo;s quality of life by disturbing daily activity, performance, confidence, social interactions, and mental health. In the majority of patients with HH (93%), the etiology of excess sweating is idiopathic, which classifies it as primary focal HH. Mild HH may be controlled with topical antiperspirants and lifestyle modifications. Based on the location of involvement, iontophoresis and botulinum toxin may be considered if the patient does not respond to topical therapies. Despite minimizing sweating, chronic use of systemic anticholinergics, in particular oxybutynin, may result in detrimental adverse effects such as dementia. Local surgery, radiofrequency, microwave, and lasers are other potential modalities for HH. Sympathectomy can be a last resort for the treatment of focal HH of the palmar, plantar, axillary, and craniofacial areas after failure of less invasive therapeutic options. In this review, we conducted a comprehensive search in the PubMed electronic database to summarize an algorithmic approach for the treatment of HH. This can help broaden options for managing this difficult disease. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5774.

PMID:33938689 | DOI:10.36849/JDD.5774

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Increased Incidence of Premenstrual Syndrome in Females with Palmar Hyperhidrosis

Int J Environ Res Public Health. 2021 Apr 28;18(9):4697. doi: 10.3390/ijerph18094697.

ABSTRACT

BACKGROUND: Premenstrual syndrome (PMS) is a common disorder affecting the quality of life of women of reproductive age. In a previous study, sex hormone imbalances and alterations in autonomic function were present in PMS, with parasympathetic dysfunction and sympathetic overactivity during the late luteal phase. Palmar hyperhidrosis (PH) presents with oversweating, heat and emotional stimulation, sympathetic hyperactivity and parasympathetic hypofunction. We hypothesized that the incidence of PMS is increased in females with PH.

METHODS: Data were retrieved from the Taiwanese National Health Insurance Database. The patients with PH were identified by the International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM) disease code 780.8. Female patients matched by age and index day were used as the control group. The incidence of PMS was considered an outcome by the ICD-9-CM disease code 625.4. The factors related to PMS were analyzed by Cox regression.

RESULTS: The adjusted hazard ratio for the incidence of PMS was 1.276 (95% confidence interval: 1.05-1.488) in females with PH.

CONCLUSIONS: This study found a positive correlation between PMS and female PH patients. Patients and physicians must understand the relationship of PMS with autonomic function alterations and other risk factors to prevent this problematic disorder.

PMID:33925001 | DOI:10.3390/ijerph18094697

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Moisture Response Films Versus the Starch Iodine Test for the Detection of Palmar Hyperhidrosis

Dermatol Surg. 2021 Apr 16. doi: 10.1097/DSS.0000000000003006. Online ahead of print.

ABSTRACT

BACKGROUND: The starch iodine test (SIT) is the gold-standard diagnostic tool for primary palmar hyperhidrosis (PPH).

OBJECTIVE: This study aimed to evaluate the clinical effectiveness and safety profile of a novel approach for the detection of PPH by moisture response films (MRF) in comparison to the SIT.

METHODS: This prospective comparative study of the 2 tests was conducted on 17 patients with PPH. Disease severity was evaluated by the SIT and the MRF methods during 4 sessions (twice before and twice after botulinum toxin [BTX] injections) on different days and by different investigators. The physician’s global assessment (PGA) scoring of the comparable visual results was evaluated by 2 blinded independent dermatologists. The Hyperhidrosis Disease Severity Scale (HDSS) scores of the patients at baseline and after the BTX injections were correlated with the SIT and MRF results.

RESULTS: The objective PGA scoring of the SIT results demonstrated poor correlation, whereas the objective PGA scoring of the MRF results correlated highly with the patients’ HDSS scores both at baseline and after the BTX injections.

CONCLUSION: Analysis of palmar hyperhidrosis by means of MRF was superior to SIT and was demonstrated to be more efficient, convenient, and accurate.

PMID:33899794 | DOI:10.1097/DSS.0000000000003006

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Treatment of primary axillary hyperhidrosis with a cream formulation of oxybutynin chloride 10

J Eur Acad Dermatol Venereol. 2021 Apr 23. doi: 10.1111/jdv.17297. Online ahead of print.

ABSTRACT

Primary focal hyperhidrosis is a common disorder with a significant impact on quality of life1 . Topical anticholinergics are an emerging therapeutic class in the treatment of focal hyperhidrosis. Glycopyrronium tosylate 3.75% cloth was FDA approved for the treatment of axillary hyperhidrosis in adults and children aged 9 years or older in 2018.

PMID:33893675 | DOI:10.1111/jdv.17297