Category: Axillary

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Long-term efficacy and safety of 1% glycopyrronium bromide cream in patients with severe primary axillary hyperhidrosis: results from a Phase 3b trial

J Eur Acad Dermatol Venereol. 2023 Jan 6. doi: 10.1111/jdv.18843. Online ahead of print.

ABSTRACT

BACKGROUND: Primary axillary hyperhidrosis (PAHH) strongly affects the patient’s quality of life. To date, topical treatment options are limited. 1% glycopyrronium bromide (GPB) showed promising efficacy and safety in a pivotal 4-week Phase 3a study.

OBJECTIVES: To assess efficacy and safety of topical 1% GPB cream in patients with severe PAHH in a long-term study of 72 weeks vs. baseline.

METHODS: This was a long-term, open-label, Phase 3b trial for 72 weeks including 518 patients with severe PAHH. Patients were treated with 1% GPB cream once daily for 4 weeks, followed by a flexible dosing scheme (min. twice per week, max. once daily). Primary endpoint was the absolute change in sweat production from baseline to week 12. Further study endpoints included assessment of the severity of PAHH and the impact on quality of life.

RESULTS: Total median sweat production decreased by 119.30 mg (-65.6%, both median) until week 12. Absolute change in sweat production from baseline to week 12 in logarithmic values was statistically significant (p < 0.0001). Patients’ quality of life was improved at all study time points compared to baseline, as assessed by Hyperhidrosis Quality of Life Index and Dermatology Life Quality Index (p < 0.0001). Treatment was safe and locally well-tolerated with only few mild to moderate adverse drug reactions (ADRs). Dry mouth and application site erythema were the most common reported ADRs.

CONCLUSIONS: Treatment with 1% GPB cream over 72 weeks significantly reduces sweat production and improves quality of life in patients with severe PAHH. 1% GPB cream is well-tolerated and provides an effective treatment option for long-term use in patients with severe PAHH.

PMID:36606529 | DOI:10.1111/jdv.18843

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Association of primary focal hyperhidrosis with anxiety induced by sweating: A cross-sectional study of Japanese university students focusing on the severity of hyperhidrosis and site of sweating

J Dermatol. 2022 Oct 25. doi: 10.1111/1346-8138.16617. Online ahead of print.

ABSTRACT

Hyperhidrosis significantly reduces patients’ quality of life, with many reporting feeling highly anxious. However, the relationship between hyperhidrosis and anxiety induced by sweating has not been examined in detail. The current study examined the relationship between: (1) the presence of hyperhidrosis symptoms, (2) hyperhidrosis severity, and (3) the sites of the most sweating and anxiety induced by sweating. A cross-sectional web-based survey was conducted among university students, and 1080 consenting participants (600 males and 480 females; mean age, 18.8 years) were included in the analysis. The survey items were: (1) diagnostic criteria for hyperhidrosis, (2) Hyperhidrosis Disease Severity Scale, (3) presence of anxiety induced by sweating, and (4) site of the most sweating. The results of multiple logistic regression analysis adjusted for sex and age showed that the odds ratio (OR) for anxiety induced by sweating was significantly higher in participants who screened positive for hyperhidrosis than in those who screened negative (OR, 9.72 [95% CI, 5.80-16.27]). The OR of anxiety induced by sweating was 7.11 (95% CI, 3.99-12.65) for mild/moderate hyperhidrosis and 23.46 (95% CI, 7.15-76.93) for severe hyperhidrosis, compared with those who screened negative for hyperhidrosis. Compared with those who screened negative for hyperhidrosis, the OR for anxiety induced by sweating in those with the palmar, plantar, axillary, and head/face as the site of the most sweating was 7.74 (95% CI, 3.91-15.33), 14.86 (95% CI, 1.83-120.58), 16.92 (95% CI, 5.95-48.14), and 5.38 (95% CI, 1.39-20.74), respectively. Our findings suggest that participants who screened positive for hyperhidrosis, mild/moderate or severe, are at a higher risk of anxiety induced by sweating than participants who screened negative for hyperhidrosis.

PMID:36282908 | DOI:10.1111/1346-8138.16617

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Impact of microwave thermolysis energy levels on patient-reported outcomes for axillary hyperhidrosis and osmidrosis

Lasers Surg Med. 2022 Oct 13. doi: 10.1002/lsm.23610. Online ahead of print.

ABSTRACT

OBJECTIVE: Microwave thermolysis (MWT) is an emerging treatment for axillary hyperhidrosis reducing both sweat and odor. No prior studies have investigated and compared the different available energy settings of the MWT device. This study evaluated patient-reported outcome measures (PROMs) for axillary hyperhidrosis and osmidrosis following MWT treatment with two different energy levels.

METHODS: Twenty adults with axillary hyperhidrosis and osmidrosis reported sweat on Hyperhidrosis Disease Severity scale (HDSS: 1-4) and odor on Odor scale (OS: 1-10), respectively, supplemented by overall Dermatology Life Quality Index (DLQI: 0-30). This was a prospective, randomized, patient-blinded and intraindividually controlled study with 3 months follow-up (FU). Randomization comprised MWT treatment of one axilla with a standard medium energy setting (energy level 3) and the contralateral axilla with a standard high energy setting (energy level 5).

RESULTS: At baseline, patients reported substantial sweat and odor, negatively affecting their quality of life. At 3 months FU, PROMs showed improved quality of life with significantly reduced odor and sweat. Overall DLQI was reduced from a median of 10 to 4, with a median 6.5-point reduction (p = 0.0002). HDSS was reduced from a median of 4 to 2 on both sides, with a median reduction of 1 for medium energy level and 2 points for high energy level (p = 0.014). OS was reduced from a median of 8 to 3 for both energy levels, with a median reduction of 3.5 and 4.5 points for the medium and high energy level, respectively (p = 0.017). Local skin reactions were mild and transient, but slightly more pronounced following treatment with the high energy level.

CONCLUSION: MWT effectively improved patients’ quality of life, axillary sweat, and odor 3 months after on baseline treatment. Treatment with the high energy level presented a subtle but significant increase of efficacy based on PROMs for both sweat and odor. Patients were willing to accept a higher amount of temporary local skin reactions from a higher energy setting when experiencing greater odor and sweat reduction.

PMID:36229952 | DOI:10.1002/lsm.23610

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A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects With Axillary Hyperhidrosis

Dermatol Surg. 2022 Sep 20. doi: 10.1097/DSS.0000000000003598. Online ahead of print.

ABSTRACT

BACKGROUND: One-third of U.S. adults are bothered by excessive sweating and 5% suffer from hyperhidrosis, both of which negatively affect quality-of-life (QoL). A single-use disposable patch using the novel targeted alkali thermolysis (TAT) technology is being developed to address this condition.

OBJECTIVE: Assess the efficacy and safety of the TAT patch for the treatment of excessive sweating using a randomized, double-blind, sham-controlled study design.

MATERIALS AND METHODS: Adults with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 (n = 16) were treated with an active or sham patch for up to 3 minutes (as established in a previous unpublished feasibility study) and evaluated weekly for 6 weeks post-treatment. The primary effectiveness measure was improved HDSS at Week-4.

RESULTS: The study met its objective. For the primary efficacy measure, 83% of TAT-treated subjects reported HDSS scores of 1 or 2 at Week-4 versus 0% of sham-treated subjects (p = .0032). Furthermore, 67% of TAT-treated subjects had a 2-point improvement in HDSS scores versus 0% of sham-treated subjects (p = .0123). Quality-of-life improvement correlated with HDSS. The TAT patch seemed to be well-tolerated; one transient moderate adverse event that resolved without sequelae was reported.

CONCLUSION: The TAT patch successfully demonstrated efficacy and was well-tolerated.

PMID:36129240 | DOI:10.1097/DSS.0000000000003598

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Adhesive Tape to Guide Injection Depth of Botulinum Toxin for Axillary Hyperhidrosis

Cutis. 2022 Jun;109(6):334-335. doi: 10.12788/cutis.0530.

ABSTRACT

OnabotulinumtoxinA for treating axillary hyperhidrosis requires a 2- to 3-mm depth of injection. This small depth is difficult to accurately estimate once the needle tip is in the skin. We have found that measuring 2 to 3 mm on the needle tip and then wrapping a piece of adhesive tape at that point acts as a depth guide.

PMID:35960963 | DOI:10.12788/cutis.0530

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Real sweating in a virtual stress environment: Investigation of the stress reactivity in people with primary focal hyperhidrosis

PLoS One. 2022 Aug 2;17(8):e0272247. doi: 10.1371/journal.pone.0272247. eCollection 2022.

ABSTRACT

BACKGROUND: Hyperhidrosis (excessive sweating, OMIM %114110) is a complex disorder with multifactorial causes. Emotional strains and social stress increase symptoms and lead to a vicious circle. Previously, we showed significantly higher depression scores, and normal cortisol awakening responses in patients with primary focal hyperhidrosis (PFH). Stress reactivity in response to a (virtual) Trier Social Stress Test (TSST-VR) has not been studied so far. Therefore, we measured sweat secretion, salivary cortisol and alpha amylase (sAA) concentrations, and subjective stress ratings in affected and non-affected subjects in response to a TSST-VR.

METHOD: In this pilot study, we conducted TSST-VRs and performed general linear models with repeated measurements for salivary cortisol and sAA levels, heart rate, axillary sweat and subjective stress ratings for two groups (diagnosed PFH (n = 11), healthy controls (n = 16)).

RESULTS: PFH patients showed significantly heightened sweat secretion over time compared to controls (p = 0.006), with highest quantities during the TSST-VR. In both groups, sweating (p < 0.001), maximum cortisol levels (p = 0.002), feelings of stress (p < 0.001), and heart rate (p < 0.001) but not sAA (p = 0.068) increased significantly in response to the TSST-VR. However, no differences were detected in subjective ratings, cortisol concentrations and heart rate between PFH patients and controls (pall > 0.131).

CONCLUSION: Patients with diagnosed PFH showed stress-induced higher sweat secretion compared to healthy controls but did not differ in the stress reactivity with regard to endocrine or subjective markers. This pilot study is in need of replication to elucidate the role of the sympathetic nervous system as a potential pathway involved in the stress-induced emotional sweating of PFH patients.

PMID:35917298 | DOI:10.1371/journal.pone.0272247

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Questionnaire-based epidemiological survey of primary focal hyperhidrosis and survey on current medical management of primary axillary hyperhidrosis in Japan

Arch Dermatol Res. 2022 Jun 29. doi: 10.1007/s00403-022-02365-9. Online ahead of print.

ABSTRACT

To obtain current epidemiological information on primary focal hyperhidrosis in Japan, a large epidemiological survey was conducted using a web-based questionnaire. The prevalence of primary focal hyperhidrosis was 10.0% and the site-specific prevalence was highest for primary axillary hyperhidrosis (5.9%). The proportion of respondents with primary focal hyperhidrosis who had consulted a physician was 4.6%, which was similar to the low prevalence reported previously in 2013 in Japan. A questionnaire survey for physicians and individuals with primary axillary hyperhidrosis on the current medical management of primary axillary hyperhidrosis showed that physicians recognized the existence of patients who were very worried about hyperhidrosis, but failed to provide active treatment. Regarding the information provided by patients to physicians at presentation, it was found that patients failed to provide sufficient information to the physicians about their worries in daily life. Among individuals who had sought medical care with primary axillary hyperhidrosis, 62.3% reported that they were not currently receiving treatment, highlighting a challenge to be addressed regarding continued treatment. Frequently chosen options leading to willingness to receive treatment were less expensive treatment and highly effective treatment as well as feeling free to consult a physician, suggesting a desire for an improved medical environment.

PMID:35768620 | DOI:10.1007/s00403-022-02365-9

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Clinical efficacy of microwave in the treatment of axillary osmidrosis and primary hyperhidrosis

Dermatol Ther. 2022 Jun 21:e15657. doi: 10.1111/dth.15657. Online ahead of print.

ABSTRACT

BACKGROUND: Axillary osmidrosis(AO) and primary hyperhidrosis(PH) are common diseases, but there are still difficulties in treatment. Microwave therapy may become a new method.

OBJECTIVE: To evaluate long-time efficacy of patients with AO or PH treated by microwave. To discuss possible mechanism of microwave therapy by combining results of clinical and pathological.

METHODS: Ten AO or PH patients with moderate or severe level were selected as subjects, and each subject received microwave treatment of bilateral armpits. The follow-up period lasted two years,and the changes of perspiration and odor were evaluated in subjective and objective ways. Each subject took skin biopsy in the treatment area before and after treatment or each follow-up. HE and immunohistochemical staining were performed.

RESULTS: Both subjective and objective index reflected the significant improvement of AO and PH after treatment(P<0.05). Dermatology life quality index score decreased by 10.4±4.6(P<0.05). The number of apocrine glands decreased significantly after treatment, and most of them changed from secretory phase to quiescent phase.

CONCLUSIONS: Microwave therapy can destroy apocrine sweat glands, reduce number of functional glands, so as to improve symptoms of AO and PH and elevate quality of life, which is safe, effective and stable. This article is protected by copyright. All rights reserved.

PMID:35726636 | DOI:10.1111/dth.15657

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THE PHARMACOLOGICAL TREATMENT AND MANAGEMENT OF HYPERHIDROSIS

Expert Opin Pharmacother. 2022 Jun 10. doi: 10.1080/14656566.2022.2083499. Online ahead of print.

ABSTRACT

INTRODUCTION: Idiopathichyperhidrosis is a dysfunctional disorder involving eccrine sweat glands and its impact on patients’ daily quality of life is well-known. Unlike some years ago, when only poor effective and safe therapeutic alternatives were available, nowadays, several emerging pharmacological active substances have gained significant space as treatment options.

AREAS COVERED: The authors report on, in this narrative review, the emerging data from the literature focusing on the pharmacological treatments to draw up a drug treatments flow-chart for patients with idiopathic hyperhidrosis, taking into consideration specific differences among axillary, palmoplantar and craniofacial hyperhidrosis.

Idiopathic hyperhidrosis, regardless of the site of involvement, remains a functional disorder that places a significant burden on patients. After balancing efficacy against adverse events, systemic therapy, although off-label for all forms of hyperhidrosis can represent an additive therapeutic option for patients with insufficient response to topical treatment according to a step wise therapeutic approach. Until the pathophysiological mechanisms underlying hyperhidrosis are clear, and the etiological therapeutic approach become realistic, the greatest challenge in the therapeutic management of hyperhidrotic patients seems to be the search for the most convenient combination between different therapeutic modalities (topical and systemic agents, and botulinum toxins) to achieve long-term control of the disease symptoms.

PMID:35686667 | DOI:10.1080/14656566.2022.2083499

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Factors associated with efficacy of botulinum toxin A injections in primary axillary hyperhidrosis: a retrospective study of ninety patients

Dermatol Ther. 2022 Jun 6:e15620. doi: 10.1111/dth.15620. Online ahead of print.

ABSTRACT

INTRODUCTION: Primary focal hyperhidrosis (PFH) is a frequent condition which can seriously affect the quality of life. Intradermal injections of botulinum toxin A (BTA) is a safe temporary treatment. The objective was to assess the factors associated with the efficacy of the axillary injections of abobotulinumtoxinA in PFH.

MATERIALS AND METHODS: Among a cohort of 236 patients followed for axillary injections of BTA between 2001 and 2020 for severe PFH, we included patients treated with 150 units per armpit of abobotulinumtoxinA with a minimum follow-up of three years. We described the characteristics of the patients and then searched for association between variables (sex, age, multifocal PFH and duration of efficacy of the first injection [<6 or ≥ 6 months]) and the number of injections received in three years, counted at the second injection date, by univariate and multivariate logistic regression.

RESULTS: Ninety patients were included (62 women, median age of 29 years and 12.2% of multifocal PFH). The median duration of efficacy of the first injection was six months (interquartile range 3-9). The duration of efficacy of the first injection ≥ 6 months was significantly associated with less injections during the 3-year follow-up in univariate (odds ratio [OR]: -1.18 [95% confidence interval (CI): -1.80 – -0.55] ; p<0.01) and multivariate (OR: -1.16 [95% CI: -1.79 – -0.53] ; p<0.01) logistic regression. There was no significant difference with female sex, age, or multifocal PFH.

CONCLUSION: A duration of efficacy of the first injection greater than six months seems to indicate a better response profile to BTA.

PMID:35669995 | DOI:10.1111/dth.15620