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Long-term evaluation of the safety and efficacy of a novel 20% oxybutynin hydrochloride lotion for primary palmar hyperhidrosis: An open-label extension study

J Dermatol. 2023 Aug 21. doi: 10.1111/1346-8138.16922. Online ahead of print.

ABSTRACT

The long-term safety and efficacy of 52-week application of oxybutynin hydrochloride 20% lotion (20% OL) for the treatment of primary palmar hyperhidrosis (PPHH) in Japanese patients aged ≥12 years were evaluated in an open-label extension (OLE) of a 4-week, randomized, double-blind (DB) study. The OLE included 114 patients who completed the DB study and wished to continue treatment and 12 new patients. In the safety analysis population (125 patients), the incidence of adverse events (AEs) and adverse drug reactions (ADRs) was 79.2% and 36.0%, respectively. Serious AEs were observed in two patients but were considered unrelated to the investigational drug. The incidence of AEs that led to study discontinuation was 1.6%. The incidence of application site AEs and ADRs was 35.2% and 26.4%, respectively. The severity of most events was mild. The incidence of anticholinergic AEs related to dry mouth was 3.2% for thirst and 0.8% for dry throat. The long-term efficacy of 20% OL was confirmed by a long-lasting reduction in sweat volume and improvement in the Hyperhidrosis Disease Severity Scale and Dermatology Life Quality Index. This study has several limitations: First the results may include some bias because most of the participants were from the prior DB study; second, the results may not be generalizable because only a few participants were in the age group most susceptible to PPHH (i.e., < 15 years old); and third, the study did not obtain safety information from treatment for more than 52 weeks, so this information must be collected in clinical practice in the future. No reduced therapeutic effect was observed in patients with PPHH in this study after 52-week application of 20% OL. Also, few patients experienced serious AEs or AEs that led to study treatment discontinuation.

PMID:37605375 | DOI:10.1111/1346-8138.16922

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Topical Oxybutynin 3% Gel Versus Aluminum Chloride 15% Lotion in Treatment of Primary Focal Hyperhidrosis

Dermatol Pract Concept. 2023 Jul 1;13(3). doi: 10.5826/dpc.1303a192.

ABSTRACT

INTRODUCTION: Hyperhidrosis is excessive sweating beyond thermoregulatory needs. It is a potentially disabling condition with challenging management. Aluminum chloride is the established topical treatment; however, response remains unsatisfactory. Oxybutynin is an anticholinergic drug that stands as a therapeutic chance for hyperhidrosis.

OBJECTIVES: comparing the efficacy of topical oxybutynin 3% gel versus aluminum chloride 15% lotion in treatment of primary focal hyperhidrosis.

METHODS: Forty patients with hyperhidrosis were randomly distributed into 2 equal groups treated by either topical oxybutynin 3% gel or topical aluminum chloride 15% lotion once daily night application for 4 weeks (both groups). Evaluation was done at 2 and 4 weeks of treatment and after 1 month of the end of treatment for follow up by Minor iodine starch test, hyperhidrosis disease severity scale (HDSS) and dermatology life quality index (DLQI).

RESULTS: Both treatment modalities were effective with insignificant differences between patients of both groups regarding improvement in Minor iodine starch test and HDSS after 2 weeks of treatment (P = 0.561, 0.33 respectively). Oxybutynin 3% gel yielded significantly better improvement of Minor’s test, HDSS and patient’s quality of life at the end of 4 weeks of treatment with lower recurrence rate than aluminum chloride 15% lotion at 1 month follow up. Minimal adverse effects were noted in both studied groups.

CONCLUSIONS: Oxybutynin 3% gel could be considered as a promising treatment modality for hyperhidrosis with higher efficacy than aluminum chloride 15% lotion and lower recurrence rate.

PMID:37557105 | DOI:10.5826/dpc.1303a192

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Development and Validation of a Nomogram to Predict Recurrence of Primary Hyperhidrosis after CT-guided Percutaneous Radiofrequency Sympathectomy

J Vasc Interv Radiol. 2023 Aug 5:S1051-0443(23)00568-7. doi: 10.1016/j.jvir.2023.07.030. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the recurrence rate of primary hyperhidrosis (PH) after computed tomography (CT)-guided radiofrequency sympathectomy (RFS) and to identify risk factors associated with recurrence.

MATERIALS AND METHODS: A total of 290 patients with PH who received CT-guided RFS were included in this retrospective cohort study. The electronic medical record was queried for patients’ information and surgical parameters. Follow-ups were conducted for recurrence rate, and Hyperhidrosis Disease Severity Scale was used to assess presence or absence of recurrence. Stepwise regression and the least absolute shrinkage and selection operator regression algorithms were used for feature selection.

RESULTS: The recurrence rate 1 year after procedure was 17.6%. Male (hazard ratio [HR]: 2.35, 95% confidence interval [CI]:1.08-5.15), low postoperative palm or foot temperature (HR: 0.77, 95% CI:0.60-0.98), high postoperative heart rate (HR: 1.06, 95% CI:1.02-1.10), low preoperative and postoperative hospital anxiety and depression score difference (HR: 0.59, 95% CI:0.43-0.80), and the absence of compensatory hyperhidrosis immediately after procedure (HR: 0.46, 95% CI:0.22-0.98) were established as independent factors affecting prognosis. A nomogram was built accordingly. The C-indices of the training and testing sets were 0.773 and 0.659, respectively.

CONCLUSION: Follow-up results showed that the recurrence rate of PH treated with CT-guided RFS was low. This study constructed and validated a nomogram to predict the recurrence of PH 1 year after CT-guided RFS, which is convenient for interventionalists to accurately evaluate the prognosis of postoperative patients, identify high-risk patients who need more active treatment.

PMID:37549843 | DOI:10.1016/j.jvir.2023.07.030

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The application of microwaves in axillary hyperhidrosis: Curative effect observation of a pathological examination over 1 year

J Cosmet Dermatol. 2023 Aug 7. doi: 10.1111/jocd.15909. Online ahead of print.

ABSTRACT

BACKGROUND: In Asia, axillary hyperhidrosis is a frequent problem for many people, and the consequent excessive sweating can seriously affect many aspects of daily life and even lead to mental disorders. Microwave therapy is a new, non-invasive treatment method for axillary hyperhidrosis, whose energy and long-term effectiveness still needs to be clinically validated.

OBJECTIVE: The aim of this study was to evaluate the clinical efficacy, safety, histological changes, and psychological status of microwave devices in the treatment of axillary hyperhidrosis and osmidrosis.

METHOD: We conducted a prospective self-controlled study in a top-tier Chinese hospital. After a 5/5 energy treatment session, a skin biopsy was taken to observe histological changes both before and after treatment. An iodine starch test was used to determine the sweating range. We evaluated symptoms of improved efficacy using the Hyperhidrosis Disease Severity Scale (HDSS) and assessed changes in life status with the DLQI. In the case of concurrent underarm odor, odor-5, VAS, and Young-Jin Park grading were used to assess odor relief. The effect of odor on psychology was assessed by using a psychological status symptom checklist (scl-90). The study period was 1 year.

RESULTS: We observed 20 patients in this study. Of those, 90% met the primary treatment endpoint of a decrease in axillary hyperhidrosis symptomatology to below grade 2 on the HDSS score (p < 0.001). Furthermore, 75% of patients achieved a treatment endpoint of at least 50% reduction in VAS (p < 0.001). 70% of patients achieved a treatment endpoint of at least 50% reduction in odor-5 (p < 0.001). The iodine starch test showed that the region decreased 99% from the baseline to 12 months after follow-up had ended (p < 0.001). Eight patients volunteered to undergo histological examination; their average light density of immunohistochemistry decreased from 1.04 (0.4-2.11) to 0.07 (0.04-0.46; p < 0.05). The immunohistochemical positive number for sweat glands was initially 104 (59.75-132.5) but was 41.5 (29.75-62) after the procedure. None of the patients experienced any serious adverse reactions.

CONCLUSION: The treatment demonstrated high effectiveness, safety, and short-lived adverse reactions.

PMID:37547985 | DOI:10.1111/jocd.15909

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PAI1 inhibits the pathogenesis of primary focal hyperhidrosis by targeting CHRNA1

Orphanet J Rare Dis. 2023 Jul 21;18(1):205. doi: 10.1186/s13023-023-02808-0.

ABSTRACT

BACKGROUND: Primary focal hyperhidrosis (PFH) may be attributed to the up-regulation of the cholinergic receptor nicotinic alpha 1 subunit (CHRNA1) in eccrine glands. Plasminogen activator inhibitor-1 (PAI1, encoded by SERPINE1) is reported to inhibit the expression of CHRNA1, while the role of PAI1 in hyperhidrosis is unknown.

METHODS: Serpine1 KO mice, Serpine1-Tg mice, and wild type BALB/c mice were intraperitoneally injected with pilocarpine hydrochloride to induce PFH. Cisatracurium (CIS, antagonist of CHRNA1) or PAI-039 (small-molecule inhibitor of PAI1) was pre-administrated before the induction of hyperhidrosis. On the other hand, Chrna1-expressing AAV was constructed and administered to Serpine1-Tg mice with hydrochloride stimulation. Hydrochloride-related biomarkers, such as acetylcholine (ACH) in the serum, calcium voltage-gated channel subunit alpha1 C (CACNA1C), and aquaporin 5 (AQP5) in sweat glands of mice were assayed with ELISA, RT-PCR, and Western blot.

RESULTS: The administration of PAI-039 or Pai1 knock-out increased Chrna1 expression, sweat secretion, and hydrochloride-related biomarkers (ACH, CACNA1C, and AQP5) expression. On the other hand, CIS administration diminished the strengthened hyperhidrosis phenotype induced by Pai1 knock-out with decreased sweat gland secretion.

CONCLUSION: PAI1 inhibits CHRNA1-mediated hydrochloride-induced hyperhidrosis, with decreased sweat gland secretion and diminished ACH, AQP5, and CACNA1C expression. These results indicate the potential to utilize PAI1 to alleviate PFH.

PMID:37542348 | DOI:10.1186/s13023-023-02808-0

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Therapeutic Effectiveness of Needle Injection Versus Needle-Free Jet Injector System for Botulinum Toxin Type a in Palmar Hyperhidrosis

J Cutan Med Surg. 2023 Aug 3:12034754231191062. doi: 10.1177/12034754231191062. Online ahead of print.

ABSTRACT

BACKGROUND: The most important problem with local injections of botulinum toxin type A (BTX-A) in palmar hyperhidrosis is pain during the injections.

OBJECTIVES: We evaluated therapeutic effectiveness and pain of local injections of BTX-A using needle-free direct administration system.

METHODS: We performed BTX-A local injection therapy using a conventional injection needle in the left hand and a needle-free direct administration system in the right hand.

RESULTS: A reduction in the quantity of perspiration was observed 4 weeks after administration of both Needle and Needle-free BTX-A, and reduction was maintained throughout 28 weeks observation period. Both hyperhidrosis Disease Severity Scale scores and Dermatology Life Quality Index for hands treated with Needle BTX-A and hands treated with Needle-free BTX-A had decreased significantly by 4 weeks after treatment. Pain visual analog scale scores and the degree of pain were significantly lower in hands treated with Needle-free BTX-A than in hands treated with Needle BTX-A.

CONCLUSIONS: When the trigger of the pressurized needle-free injector device is activated, the gas powered driving pressure propels BTX-A through an orifice (0.13 mm) about four times narrower than a 30 G needle at very high speed. As most pain occurs during the needle prick itself, the advantage of a small orifice coupled with high-speed penetration of BTX-A through the pressurized device results in reduced pain during administration. The needle-free direct administration system administers the injectate under the skin without a visible needle.

PMID:37537972 | DOI:10.1177/12034754231191062

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Compensatory Hyperhidrosis After Non-Surgical Treatment of Primary Focal Hyperhidrosis: Two-Year Single-Centered Prospective Study From Jordan

J Cutan Med Surg. 2023 Jul 31:12034754231191488. doi: 10.1177/12034754231191488. Online ahead of print.

ABSTRACT

BACKGROUND: Primary focal hyperhidrosis (PH) can be managed by a wide range of medical and surgical modalities. Compensatory hyperhidrosis (CH) is a well-documented complication of surgical treatment. We aimed to investigate the occurrence of compensatory hyperhidrosis (CH) in PH patients after nonsurgical treatment with botulinum toxin A (BTX- A) or iontophoresis.

METHODOLOGY: We carried out a unicentric prospective study on PH patients from King Abdullah University Hospital (KAUH) in Jordan. PH patients were evaluated after 1-month of nonsurgical treatment. Patients who developed CH were re-assessed after 3-6 months through a telephone-based interview.

RESULTS: A total of 86 patients with PH who underwent nonsurgical treatment with iontophoresis or botulinum toxin were recruited. Twenty-four (27.9%) patients developed subjective CH. It was mild in (75%), moderate in (21%), and severe in (4%) of patients affected, it was self-limiting within a few months in all patients. Patients with CH did not differ significantly in demographic or clinical variables from patients who did not develop CH except at the site of PH (p value = .05).

CONCLUSION: The findings of this study indicate that more than quarter (27.9%) of patients with PH may develop minor compensatory sweating, however this didn’t affect satisfaction with treatment.

PMID:37522712 | DOI:10.1177/12034754231191488

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Hyperhidrosis: A targeted literature review of the disease burden

J Dermatol. 2023 Jul 31. doi: 10.1111/1346-8138.16908. Online ahead of print.

ABSTRACT

Hyperhidrosis is a chronic skin condition characterized by excessive sweating. It poses a burden on affected people, reducing their quality of life and productivity. We undertook a targeted literature review (TLR) to gather current evidence on the epidemiology as well as the human and economic burden posed on patients with hyperhidrosis. Searches were performed in Medline database (access via OVID interface) and ICHUSHI database. Articles published between January 2000 and September 2020 that analyzed at least 50 patients were included. Sixty-four publications were identified and 38 publications covering a unique domain were selected to inform this TLR. The incidence of hyperhidrosis ranged from 0.13% in the UK to 0.28% in the USA, with a higher rate in females. The prevalence of hyperhidrosis varied from 2.8%-4.8% in the US general population to 18.40% in Chinese inpatients, while the prevalence of axillary hyperhidrosis varied from 1.4% in the US general population to 5.75% in Japanese employees/students. Due to excessive sweating, hyperhidrosis was reported to be a moderate-to-extreme limitation at work for the US patients, with 33.5% feeling unhappy. Patients’ satisfaction was high post-treatment. Considerable costs were related to the treatment with botulinum toxin and surgery. Hospital stays for surgery lasted from 10 h to 3 days. The percentage of patients who sought a medical consultation varied from 6.3% for Japanese patients with primary focal hyperhidrosis to 51% for the US general population with any type of hyperhidrosis. There is limited evidence of the hyperhidrosis burden, particularly among Japanese patients; however, the burden was high and limited patients’ daily functioning. Future actions should include implementation of educational programs to raise awareness of the condition, conduct of larger studies, and generation of more evidence. Understanding the nature of hyperhidrosis and the burden it poses is of utmost importance.

PMID:37519134 | DOI:10.1111/1346-8138.16908

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Quality of life in individuals with primary hyperhidrosis: a systematic review and meta-analysis

Clin Auton Res. 2023 Jul 28. doi: 10.1007/s10286-023-00954-w. Online ahead of print.

ABSTRACT

PURPOSE: Hyperhidrosis can be a debilitating disease that leads to the deterioration of well-being. In this study, the objective was to compare the health-related quality of life (HRQOL) in individuals with and without hyperhidrosis by conducting a systematic review and meta-analysis.

METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Meta-analysis Of Observational Studies in Epidemiology checklist were employed. We systematically searched Cochrane Library, Embase and PubMed. Two authors independently assessed the literature and extracted the data. The risk of bias was assessed using the Newcastle-Ottawa Scale. A random-effects model was employed. The heterogeneity was determined using I2.

RESULTS: Eleven studies met the eligibility criteria comprising 4297 and 147,604 participants with and without hyperhidrosis, respectively. The risk of bias ranged from high quality to very high risk of bias. The individuals with hyperhidrosis had a higher Dermatology Life Quality Index (mean difference 8.53; 95% confidence interval 3.47, 13.58; p = 0.0009) and a lower mental component summary of the short form-12 or -36 (mean difference -6.15; 95% confidence interval -9.00, -3.30; p < 0.0001) than the control individuals. No difference was found for the physical component summary score of the short form-12 or -36 (mean difference -0.88; 95% confidence interval -1.88, 0.12; p = 0.085). Studies using patient-reported outcomes, not included in the meta-analysis, showed similar results.

CONCLUSION: Individuals with hyperhidrosis experience a reduced HRQOL that is clinically meaningful and leads to perceivable deteriorations in their well-being. The evidence shows a high degree of heterogeneity, which warrants additional studies.

PMID:37507605 | DOI:10.1007/s10286-023-00954-w

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Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact

Medicine (Baltimore). 2023 Jul 1;102(S1):e32764. doi: 10.1097/MD.0000000000032764.

ABSTRACT

Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal injection of onabotulinumtoxinA to treat sweat glands arose as a novel therapeutic approach. To develop this treatment, appropriate dosing needed to be established, and training on administration was required. Further, no previous scale existed to measure the effects of hyperhidrosis on patients’ lives, leading Allergan to develop and validate the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which measures the disease’s impact on daily activities. The onabotulinumtoxinA clinical development program for hyperhidrosis included 2 double-blind, placebo-controlled pivotal trials, immunogenicity studies, long-term studies of safety and efficacy, and quality of life assessments. In Europe and North America, the primary efficacy measures were, respectively, axillary sweat production measured gravimetrically and HDSS improvement. Compared with placebo, onabotulinumtoxinA treatment significantly reduced axillary sweat production and axillary hyperhidrosis severity, as measured by a 2-point or greater reduction on the HDSS. The effects of onabotulinumtoxinA occurred rapidly, within 1 week after injection, and lasted ≥6 months. Treatment with onabotulinumtoxinA was associated with significant quality of life improvements based on Short Form-12 physical and mental component scores. The Hyperhidrosis Impact Questionnaire also indicated greater treatment satisfaction, reduced negative impact on aspects of daily life, and improved emotional well-being with onabotulinumtoxinA versus placebo. The clinical development program and subsequent clinical experience showed that onabotulinumtoxinA treatment for hyperhidrosis was well tolerated with no new safety signals, and led to greater disease awareness.

PMID:37499084 | DOI:10.1097/MD.0000000000032764