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

Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis

J Dermatol. 2022 Apr 8. doi: 10.1111/1346-8138.16384. Online ahead of print.

ABSTRACT

In 2020, 5% sofpironium bromide (ECCLOCK® ) gel (hereinafter referred to as sofpironium) was approved in Japan for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium demonstrated the efficacy and safety of sofpironium; however, no study has assessed its early efficacy at <6 weeks after starting treatment. Therefore, to assess the earlier effectiveness of sofpironium, we conducted a 2-week, single-center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis. Patients aged ≥20 years and satisfying with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline were eligible for the study. The primary endpoint for the effectiveness was change in the proportion of patients with a HDSS score of 1, 2, 3, or 4 during the 2-week study period. In 80 patients included in the full analysis set (FAS), there were more women than men (93.8% vs. 6.3%), and the mean age (±standard deviation [SD]) was 33.3 ± 9.4 years. In the FAS, the proportion of patients with a HDSS score of 1 or 2 was 55.0% on day 7, and statistically significant changes were observed after day 3 compared to baseline (p < 0.05). Mean HDSS scores (±SD) were significantly decreased from baseline value of 3.5 ± 0.5 to 2.4 ± 0.9 on day 7 (p < 0.001). The median period for sofpironium treatment to achieve a HDSS score of 1 or 2 for a continuous 2 days was 6 days (95% confidence interval, 4-8). Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks. These results suggest that after 1-week treatment with sofpironium for patients with a HDSS score of 3 or 4, approximately 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients.

PMID:35394087 | DOI:10.1111/1346-8138.16384

Cohort study on 20 years’ experience of bilateral video-assisted thoracic sympathectomy (VATS) for treatment of hyperhidrosis in 2431 patients

Sao Paulo Med J. 2022 Feb 21:S1516-31802022005004202. doi: 10.1590/1516-3180.2021.0078.R1.23072021. Online ahead of print.

ABSTRACT

BACKGROUND: Primary hyperhidrosis is a condition characterized by excessive sweating, inconsistent with the needs for thermoregulation.

OBJECTIVE: To assess the effectiveness and the change in the quality of life of patients undergoing bilateral VATS (video-assisted thoracoscopic sympathectomy) for treatment of hyperhidrosis, in a large case series.

DESIGN AND SETTING: Cohort study conducted in a tertiary hospital specializing in hyperhidrosis located in São Paulo, Brazil.

METHODS: A total of 2,431 patients who underwent surgery consisting of bilateral video-assisted thoracoscopic sympathectomy between January 2000 and February 2017 were retrospectively assessed in an outpatient clinic specializing in hyperhidrosis. The patients underwent clinical and quality of life assessments on two occasions: firstly, prior to surgery, and subsequently, one month after the operation. The presence or absence of compensatory hyperhidrosis (CH) and general satisfaction after the first postoperative month were also evaluated.

RESULTS: All the patients operated had poor or very poor quality of life before surgery. In the postoperative period, an improvement in the quality of life was observed in more than 90% of the patients. Only 10.7% of the patients did not present CH, and severe CH occurred in 22.1% of the patients in this sample.

CONCLUSION: Bilateral VATS is a therapeutic method that decreases the degree of sweating more than 90% of patients with palmar and axillary hyperhidrosis. It improves the quality of life for more than 90% of the patients, at the expense of development of CH in approximately 90% of the patients, but not intensely.

PMID:35195234 | DOI:10.1590/1516-3180.2021.0078.R1.23072021

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

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