Category: Axillary

Posted on

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

Posted on

Anatomical variation of sympathetic ganglia in R4+R5 sympathicotomy for primary palmar axillary hyperhidrosis

J Thorac Dis. 2023 Jun 30;15(6):3106-3114. doi: 10.21037/jtd-22-1782. Epub 2023 May 6.

ABSTRACT

BACKGROUND: R4+R5 sympathicotomy is one of the standard surgical treatments for primary palmar axillary hyperhidrosis (PAH), but the reported outcomes vary. Anatomical variation of sympathetic ganglia is hypothesized to be a cause for this phenomenon. The sympathetic ganglia could be visualized via near-infrared (NIR) fluorescent thoracoscopy, we utilize this novel technique to observe the anatomical variation of sympathetic ganglia T3 and T4 and investigate its relationship with surgical outcomes.

METHODS: This is a prospective multi-center cohort study. All patients received intravenous indocyanine green (ICG) infusion 24 hours preoperatively. Anatomical variation of sympathetic ganglia T3 and T4 was observed via fluorescent thoracoscopy. Standard R4+R5 sympathicotomy was performed regardless of anatomical variation. Patients were followed up for the therapeutic outcome.

RESULTS: One hundred and sixty-two patients in total were enrolled in this study and 134 patients with bilateral clearly visualized thoracic sympathetic ganglia (TSG) were included. The success rate of fluorescent imaging of thoracic sympathetic ganglion was 82.7%. The T3 ganglion was shifted downward on 32 sides (11.9%) and no upward-shifted ganglion was identified. The T4 ganglion was shifted downward on 52 sides (19.4%) and no upward-shifted ganglion was identified. All patients underwent R4+R5 sympathicotomy and no perioperative death or severe complication occurred. The total improvement rates on palmar sweating at short-term and long-term follow-up were 98.1% and 95.1%, respectively. There were significant differences between T3 normal and T3 variation subgroups both in short-term (P=0.049) and long-term (P=0.032) follow-ups. The total improvement rates on axillary sweating at short-term and long-term follow-ups were 97.0% and 89.6%, respectively. No significant difference was found between T4 normal and T4 variation subgroups both in short-term and long-term follow-ups. No significant difference was found between normal and variation subgroups on the degree of compensatory hyperhidrosis (CH).

CONCLUSIONS: NIR fluorescent thoracoscopy provides clear identification of anatomical variations of sympathetic ganglia during R4+R5 sympathicotomy. The improvement of palmar sweating was significantly affected by anatomical variation of T3 sympathetic ganglia.

PMID:37426141 | PMC:PMC10323581 | DOI:10.21037/jtd-22-1782

Posted on

Low-Dose OnabotulinumtoxinA using Seven-Point Pattern Intradermal Injections in Patients with Moderate-to-intolerable Primary Axillary Hyperhidrosis: A Single-Blinded, Side-by-Side Randomized Trial

J Clin Aesthet Dermatol. 2023 Jun;16(6):37-43.

ABSTRACT

BACKGROUND: The axilla is the most common site for primary hyperhidrosis (HH) affecting quality of life. No consensus on the optimal doses of botulinum toxin (BTX) has been established.

OBJECTIVE: This study aimed to scrutinize the effectiveness of 25- and 50-U onabotulinumtoxinA in patients with moderate-to-intolerable primary axillary HH as well as pain scores after BTX injection.

METHODS: A single-blinded, side-by-side randomized trial was conducted between January and June 2022. Participants were randomly treated with 25-unit (U) onabotulinumtoxinA in one axilla and 50-U onabotulinumtoxinA in the other. The Minor starch-iodine test and gravimetric testing, the Hyperhidrosis Disease Severity Scale (HDSS), Hyperhidrosis Quality of Life Index (HidroQoL), global self-assessment scale (GSAS), and satisfaction scores were collected and analyzed.

RESULTS: A total of 12 participants were included in the final analysis; six (50.0%) were female. The median age was 30.3 (interquartile range: 28.7-32.3) years. No statistically significant differences were noted in the sweat rate production, hyperhidrotic area, HDSS, HidroQoL, GSAS, and satisfaction scores between 25- and 50-U BTX at any follow-up visit. No significant difference was noted in pain scores between the two groups (p=0.810).

CONCLUSION: Low-dose onabotulinumtoxinA is associated with similar efficacy and safety outcomes in primary axillary HH treatment as is conventional-dose onabotulinumtoxinA. No difference was noted in injection site pain between the two groups.

PMID:37361360 | PMC:PMC10286880

Posted on

Urinary retention and mydriasis secondary to topical glycopyrronium for axillary hyperhidrosis

Am J Health Syst Pharm. 2023 Jun 22:zxad141. doi: 10.1093/ajhp/zxad141. Online ahead of print.

ABSTRACT

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

PURPOSE: Glycopyrronium, also known as glycopyrrolate, is an antimuscarinic competitive inhibitor of acetylcholine widely utilized topically for its anticholinergic properties in dermatology. A single topical glycopyrronium tosylate (GT) formulation is available on the market, and prescription of this medication has become increasingly popular among dermatologists. This medication has a relatively notable adverse effect profile and carries risks that patients need to be counseled on before initiation.

SUMMARY: A 22-year-old female presented to our emergency department (ED) with a chief complaint of difficulty urinating for 48 hours and blurred vision for 2 weeks. Over the course of a week, she visited the ED once and urgent care multiple times due to complications associated with combination use of GT and cetirizine. Although these clinical effects were reversible, the patient impact in our case was profound given the time, cost, and invasive nature of these visits.

CONCLUSION: The notable adverse effects of GT should be considered when prescribing this agent.

PMID:37348110 | DOI:10.1093/ajhp/zxad141

Posted on

Attempted treatment of primary axillary hyperhidrosis with one session of either Neodymium YAG laser or Intense Pulsed Light: A within patient randomized trial of treated versus untreated contralateral axilla

Lasers Surg Med. 2023 Jun 14. doi: 10.1002/lsm.23697. Online ahead of print.

ABSTRACT

BACKGROUND: Primary axillary hyperhidrosis (PAH) affects 1-5% of the world’s population who has an unmet need for improved treatments. The heating of sweat glands with specific microwave therapy has shown promising results, yet, treatment with widely available devices such as long-pulsed Neodymium Yttrium Aluminum Garnet (Nd:YAG) lasers, diode lasers or Intense Pulsed Light (IPL) may serve as pragmatic alternatives.

OBJECTIVES: To compare sweat secretion of treated versus untreated contralateral control axilla 1-3 months after one session of Nd:YAG laser or IPL in patients with PAH.

METHODS: A within-person randomized controlled trial. Patients were randomized to receive either one session of Nd:YAG laser or IPL in one axilla with the contra-lateral serving as control. Sweat production was assessed by gravimetry, trans-epidermal water loss, hyperhidrosis disease severity scale and dynamic optical coherence tomography. Mixed-effects models were used to handle the within-person design, containing both fixed effect factors (side, group, and subgroup), and random effects (patients), while also adjusting for the level at baseline.

RESULTS: A total of 20 patients were enrolled. At follow-up 1-3 months after treatment, sweat secretion was not affected in the treated axilla when compared to the control axillae (0.01 [95%CI: -0.04 to 0.05]; p = 0.68). In the Nd:YAG subgroup (10 patients), least squares means for sweat secretion was 0.18 mg/5 min in the treated versus 0.15 mg/5 min in the control axilla, respectively, corresponding to a statistically insignificant mean difference of 0.02 mg/5 min (95% CI: -0.06 to 0.11; p = 0.54). In the IPL subgroup (10 patients), sweat secretion was 0.06 mg/5 min in the treated axilla versus 0.07 mg/5 min in the control axilla with a statistically insignificant difference of -0.01 points (95% CI: -0.03 to 0.02; p = 0.46). Likewise, none of the secondary outcomes were significantly affected by treatment. However, both treatments appeared safe and well tolerated with no adverse effects reported at follow-up.

CONCLUSIONS: One treatment with external 1064 nm Nd:YAG laser or 640 nm IPL at commercially available settings, failed to demonstrate clinical benefit in treating PAH, with narrow confidence intervals implying that this was not due to a type-2 error.

PMID:37313834 | DOI:10.1002/lsm.23697

Posted on

Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial

J Patient Rep Outcomes. 2023 Jun 6;7(1):55. doi: 10.1186/s41687-023-00596-6.

ABSTRACT

BACKGROUND: The Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed and validated patient-reported outcome measure assessing the quality-of-life impacts in hyperhidrosis with 18 items. Our aim was to extend the already existing validity evidence for the HidroQoL, especially in relation to structural validity. Especially Rasch analysis has not been applied to the final 18-item HidroQoL before.

METHODS: Data from a phase III clinical trial were used. Confirmatory factor analysis was conducted to confirm the two a priori HidroQoL scales within classical test theory. Furthermore, the assumptions of the Rasch model (model fit, monotonicity, unidimensionality, local independence) and Differential Item Functioning (DIF) were assessed using item response theory.

RESULTS: The sample included 529 patients with severe primary axillary hyperhidrosis. The two-factor structure could be confirmed by the confirmatory factor analysis (SRMR = 0.058). The item characteristic curves showed mainly optimally functioning response categories, indicating monotonicity. The overall fit to the Rasch model was adequate and unidimensionality for the HidroQoL overall scale could be confirmed, since the first factor had an eigenvalue of 2.244 and accounted for 18.7%. Local independence was below assumed thresholds (residual correlations ≤ 0.26). DIF analysis, controlling for age or gender, was critical for four and three items, respectively. However, this DIF could be explained.

CONCLUSION: Using classical test theory and item response theory/Rasch analyses, this study provided further evidence for the structural validity of the HidroQoL. This study confirmed several specific (measurement) properties of the HidroQoL questionnaire in patients with physician-confirmed severe primary axillary hyperhidrosis: the HidroQoL is a unidimensional scale allowing the summation of scores to generate a single score, and simultaneously it has a dual structure, also allowing the calculation of separate domain scores for daily activities and psychosocial impacts. With this study, we provided new evidence of the structural validity of the HidroQoL in the context of a clinical trial. Trial registration The study was registered (ClinicalTrials.gov identifier: NCT03658616, 05 September 2018, https://clinicaltrials.gov/ct2/show/NCT03658616?term=NCT03658616&draw=2&rank=1 ).

PMID:37280417 | DOI:10.1186/s41687-023-00596-6

Posted on

Axillary Cutaneous Hemosiderosis in a Patient With Hyperhidrosis, After Intravenous Iron Infusion

Am J Dermatopathol. 2023 May 29. doi: 10.1097/DAD.0000000000002461. Online ahead of print.

ABSTRACT

Hemosiderosis consists of an iron deposit in tissues, which does not cause organic damage to them. However, in the case of the skin, being an organ exposed to sight, siderosis can produce a brownish coloration that is aesthetically discomforting for the individual. Most cutaneous sideroses are because of venous insufficiency with hemorrhagic extravasation. There is also a group secondary to iron extravasation in the injection site of the transfusion. However, there are very few cases in which an intravenous injection of an iron preparation has produced diffuse siderosis in extensive areas of the skin. We present the case of a 31-year-old woman with hyperhidrosis, who was transfused as a result of postpartum hemorrhage and, shortly after receiving an intravenous iron infusion, developed extensive hyperpigmentation in both axillae.

PMID:37249371 | DOI:10.1097/DAD.0000000000002461

Posted on

Evaluation of quality of life (QOL) of young patients with primary hyperhidrosis (PH) before and after endoscopic thoracic sympathectomy (ETS)

J Am Acad Dermatol. 2023 May;88(5):e197-e201. doi: 10.1016/j.jaad.2015.10.048.

ABSTRACT

BACKGROUND: Primary hyperhidrosis (PH) affects young patients and may cause emotional distress and a negative quality of life (QOL).

OBJECTIVE: We sought to evaluate the QOL of children and adolescents with PH treated by endoscopic thoracic sympathectomy.

METHODS: A study of 220 patients was performed, based on submitted QOL questionnaires from their first consultation. Patients were evaluated within 1 week and 24 months after surgery.

RESULTS: Before endoscopic thoracic sympathectomy, the QOL in relation to PH was declared very poor by 141 patients, and poor by the remaining 79 (P = .552). Postoperative cure was reported in 100% of palmar and axillary PH cases, and in 91.7% of facial PH. After 24 months, the QOL was described as much better by 212 patients, a little better by 6 patients, and 2 patients reported no change.

LIMITATIONS: Convenience sampling was used and patients were taken from private practice only, raising the possibility of bias in gathering the data.

CONCLUSION: Onset of PH symptoms was mainly before the age of 10 years and substantially affected daily activities. Endoscopic thoracic sympathectomy cured PH and promoted significant improvement in the QOL of these young patients.

PMID:37069802 | DOI:10.1016/j.jaad.2015.10.048

Posted on

Comparison of the efficacy of ETS with different segments for palmar, axillary and plantar hyperhidrosis

BMC Surg. 2023 Apr 11;23(1):82. doi: 10.1186/s12893-023-01976-x.

ABSTRACT

BACKGROUND: To compare the near and long-term outcomes of endoscopic thoracic sympathectomy (ETS) for palmar, axillary and plantar hyperhidrosis.

METHODS: We retrospectively analyzed the clinical data of 218 patients with hyperhidrosis who were admitted to the Department of Thoracic Surgery of Gansu Provincial People’s Hospital for surgical treatment from April 2014 to August 2021. The patients were divided into three groups according to the method of ETS and the perioperative clinical data and postoperative follow-up data were collected to compare the near and long term outcomes of the three groups.

RESULTS: There were 197 eligible patients at follow-up, 60 patients in the R4 cut-off group, 95 patients in the R3 + R4 cut-off group and 42 patients in the R4 + R5 cut-off group. There were no statistically significant differences in baseline indicators such as sex, age and positive family history among the three groups (P > 0.05). There was no statistically significant difference between the three groups in terms of operative time (P = 0.148), intraoperative bleeding (P = 0.308) and postoperative hospital stay (P = 0.407). Postoperatively, all three groups showed significant relief of palmar hyperhidrosis symptoms, with the R3 + R4 group having an advantage in terms of relief of axillary hyperhidrosis symptoms, patient satisfaction and quality of life index at 6 months postoperatively and the R4 + R5 group having an advantage in terms of relief of plantar hyperhidrosis symptoms. The difference in compensatory hyperhidrosis at 12 months postoperatively was not statistically significant among the three groups (P = 0.867), but the incidence was higher in the R3 + R4 and R4 + R5 groups than that in the R4 group.

CONCLUSION: Patients with simple palmar hyperhidrosis can first consider R4 cut-off treatment; R3 + R4 cut-off is more effective in treating palmar hyperhidrosis combined with axillary hyperhidrosis; R4 + R5 cut-off is more effective in treating palmar hyperhidrosis combined with plantar hyperhidrosis. However, patients need to be informed that R3 + R4 and R4 + R5 dissection may increase the risk of severe compensatory hyperhidrosis after surgery.

PMID:37041509 | DOI:10.1186/s12893-023-01976-x

Posted on

A single session of high-energy microwave axillary hyperhidrosis and osmidrosis therapy: Key pretherapeutic assessment and outcome analysis

Lasers Surg Med. 2023 Mar 23. doi: 10.1002/lsm.23656. Online ahead of print.

ABSTRACT

BACKGROUND: Microwave therapy is used to treat axillary hyperhidrosis and osmidrosis. Even while a “danger zone” has been identified and reports of potential complications from nerve injury have been made, there has been little real-world discussion regarding whether there is any pretreatment evaluation key factor that may lower the risk. Furthermore, the efficacy of a single treatment and the safety of high-energy therapies have not been well investigated.

OBJECTIVE: The aim of this study is to demonstrate the key aspects of pre-therapeutic assessment, efficacy, and suitability of a single treatment, as well as the safety of high-energy treatments.

METHODS: Fifteen patients with axillary hyperhidrosis (AH) and axillary osmidrosis (AO) between ages of 20 and 50 had pretherapeutic ultrasonography and clinical assessments performed followed by a single-pass microwave treatment using the miraDry system at energy level 5. The severity of AH and AO was evaluated using the Hyperhidrosis Disease Severity Scale and Odor-10 scale, respectively, at baseline, 1 month, 3 months, and 1 year after treatment. Adverse reactions were recorded at each point of evaluation.

RESULTS: Out of 30 treatment areas, 14 have a danger zone. Female gender, a small mid-upper arm circumference, and a low body mass index (BMI) are all associated risk factors. The average Hyperhidrosis Disease Severity Scale score decreased from 3.1 ± 0.7 to 1.3 ± 0.5 (p < 0.001), while the odor-10 score declined from 7.1 ± 1.6 to 3.0 ± 1.6 (p < 0.001), indicating a significant improvement in AH and AO. Most of the unfavorable treatment effects disappeared within the first month.

LIMITATIONS: This study has no objective quantitative measurement of axillary odor severity and sweat assessment.

CONCLUSION: Female patients, those with a smaller mid-upper arm circumference, and those with a low BMI should be treated with extra caution, and the tumescent anesthetic dose may be increased based on safety. A high-energy microwave treatment procedure performed in a single session is a safe and effective therapeutic option with good recovery.

PMID:36950892 | DOI:10.1002/lsm.23656