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scores of 3 or 4 (n = 16) were treated with an active or sham patch for up to 3 minutes (as established in a previous unpublished feasibility study) and evaluated weekly for 6 weeks post-treatment.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

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

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

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

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

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

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

Open-Label Cohort Study to Evaluate Efficacy and Safety of Application of Glycopyrronium Cloth, 2.4% for Palmar Hyperhidrosis

J Drugs Dermatol. 2022 May 1;21(5):488-495. doi: 10.36849/JDD.6688.

ABSTRACT

BACKGROUND: Hyperhidrosis of the palms has a significant negative impact on quality of life. There is no FDA-approved treatment; however, clinicians often use glycopyrronium cloth off-label for this indication despite the lack of published guidance on optimal method of application for treatment of palms.

OBJECTIVE: To compare the safety and efficacy of 4 different methods of application of glycopyrronium cloth to give clinicians guidance when treating palmar hyperhidrosis.

STUDY DESIGN: This study, conducted completely virtually using live interactive telemedicine, compared application times of 15 minutes, 30 minutes, and overnight without occlusion and 30 minutes under occlusion. The primary endpoint was a decrease in the mean of the Hand Severity Score (HHS) after 4 weeks of once-daily application. Safety data, including local skin reactions and other adverse events, were tabulated by cohort.

RESULTS: Of the application times and methods tested, 30 minutes without occlusion produced the greatest decrease in the HHS with an acceptable safety profile. The most common adverse event was unilateral mydriasis, which presumably occurred from inadvertent introduction of study drug into the eye despite multiple warnings to the subjects to avoid eye contact. A few subjects had adverse events presumably due to systemic absorption of the drug similar to those seen in the pivotal trials for treatment of axillary hyperhidrosis.

CONCLUSION: Glycopyrronium cloth can be used successfully to treat palmar hyperhidrosis. Occlusion for 30 minutes had the poorest response presumably due to the increased sweating causing dilution of the study drug.

CLINICALTRIALS: gov: NCT04906655 J Drugs Dermatol. 2022;21(5):488-494. doi:10.36849/JDD.6688.

PMID:35533035 | DOI:10.36849/JDD.6688

Patient experience and prognostic factors of compensatory hyperhidrosis and recurrence after endoscopic thoracic sympathicotomy

Surg Endosc. 2022 May 9. doi: 10.1007/s00464-022-09284-w. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to investigate compensatory hyperhidrosis (CH) and recurrence based on an online survey of patients who underwent endoscopic thoracic sympathicotomy(ETS) for palmar and/or axillary hyperhidrosis.

METHODS: We enrolled 231 patients who underwent ETS for palmar and/or axillary hyperhidrosis from January 2008 to April 2021. Patients responded to an online questionnaire regarding CH and recurrence, their electronic medical records were reviewed. Logistic regression was performed to find the risk factors related to CH and recurrence.

RESULTS: The median time of survey from surgery was 20 months. Although 94% of patients were satisfied with the surgery, 86.1% experienced CH; of them, it was severe in 30.7%. Three months after surgery, there was no long-term change in the severity of CH. The development of CH showed a close relationship with age of 20 years or more (OR: 2.73). Recurrence occurred in 44(19.0%) patients, and the use of anti-adhesive agents was a significant preventive factor against recurrence after ETS (OR: 0.42).

CONCLUSIONS: We observed that CH and recurrence after ETS for palmar and/or axillary hyperhidrosis were relatively common. Age at the time of surgery was associated with CH, and the use of anti-adhesive agents showed to lower the risk of recurrence after ETS.

PMID:35534737 | DOI:10.1007/s00464-022-09284-w

Transfersomal eosin topical delivery assisted by fractional CO2 laser for photodynamic treatment of palmar hyperhidrosis: case study

Drug Deliv Transl Res. 2022 Apr 20. doi: 10.1007/s13346-022-01164-z. Online ahead of print.

ABSTRACT

Hyperhidrosis is a condition in which the cholinergic receptors on the eccrine glands are overstimulated, resulting in excessive sweating. It is considered a serious cosmetic and psychological problem that affects the patient’s quality of life. Searching for novel treatment modalities is required to minimize the side effects and to attain better patient satisfaction.Photodynamic therapy (PDT), using eosin as a photosensitizer, is developed as a promising modality of the treatment of palmar and axillary hyperhidrosis. In this study, we treated six cases suffering palmar hyperhidrosis by applying the fractional CO2 laser prior to PDT session. For PDT, a hydrogel of eosin loaded in a transfersomes as a nano-delivery carrier was applied for 5 min, followed by irradiation by intense pulsed light (IPL). The prepared transfersomes loaded by eosin were spherical in shape with encapsulation efficiency of 33 ± 3.5%, particle size 305.5 ± 5.7 nm, average zeta potential of – 54 ± 7.6 mV with 80 ± 4% of the loaded eosin was released after 3 h. Two cases achieved 90% improvement after four sessions, three patients needed six sessions to show 75% improvement, while one patient showed only 25% improvement after six sessions. This resulted in shortening the time of PS application and decreasing the number of sessions required to achieve acceptable improvement. More clinical studies on large number of patients are required to optimize the results.

PMID:35441986 | DOI:10.1007/s13346-022-01164-z