Category: Axillary

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A Pivotal Study on the Safety and Effectiveness of a Targeted Alkali Thermolysis Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

Dermatol Surg. 2024 Oct 31. doi: 10.1097/DSS.0000000000004472. Online ahead of print.

ABSTRACT

BACKGROUND: One-third of US adults are bothered by excessive sweating, approximately 5% are diagnosed with hyperhidrosis. A topical patch using targeted alkali thermolysis (TAT) was developed for treatment of this condition.

OBJECTIVE: This study was intended to assess the efficacy and safety of the TAT-Patch for axillary sweat reduction.

MATERIALS AND METHODS: A randomized, multicenter, double-blind, sham-controlled, pivotal trial enrolled 120 subjects to a bilateral axillary treatment with a TAT patch (63 subjects) or sham patch (57 subjects).

RESULTS: The primary end point was achieved; 64% of TAT-treated versus 44% of sham-treated subjects (p = .0332) improved from Hyperhidrosis Disease Severity Scale (HDSS) 3/4 to HDDS 1/2 at 4 weeks. Targeted alkali thermolysis treatment also showed a statistically significant improvement over sham treatment for all secondary end points, including gravimetric sweat production and subject-reported quality-of-life (QoL) assessments. The duration of effect is approximately 3 months, determined by the time to return to baseline HDSS. Mild-to-moderate treatment-site adverse events (AEs) were reported in 22% of TAT patch subjects. No serious or severe AEs were reported.

CONCLUSION: HDSS, GSP, and QoL findings confirm clinically meaningful sweat reduction and a significant improvement in quality of life following a single TAT patch treatment. This device has potential to offer a new, noninvasive treatment option that is well tolerated with minimal downtime.

PMID:39480962 | DOI:10.1097/DSS.0000000000004472

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Longitudinal validity of the Hyperhidrosis Quality of Life Index (HidroQoL) in a phase IIIb clinical trial population with hyperhidrosis: responsiveness and meaningful change

Br J Dermatol. 2024 Oct 28:ljae415. doi: 10.1093/bjd/ljae415. Online ahead of print.

ABSTRACT

BACKGROUND: The Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed patient-reported outcome measure assessing the quality of life (QoL) impacts in hyperhidrosis, which has proven very good measurement properties, such as structural validity and internal consistency.

OBJECTIVES: We aimed to investigate responsiveness over time and estimate values for meaningful within-person change (MWPC) towards symptom improvement for different measurement time points (4 and 12 weeks), extending the existing validity evidence in patients with primary axillary hyperhidrosis.

METHODS: Data (from a phase IIIb clinical trial) was collected at baseline, week 4, week 8, week 12, week 28, week 52, and week 72. For the assessment of responsiveness, HidroQoL change scores were correlated with corresponding change scores of the Hyperhidrosis Disease Severity Scale (HDSS), the Dermatology Life Quality Index (DLQI), and the gravimetric sweat production based on a-priori formulated hypotheses. Furthermore, it was tested whether the different HDSS change score groups differed significantly from each other over time and whether the HidroQoL was sensitive towards these group differences over time. This was extended by the calculation of matched-pair tests and effect sizes to test significance for each change group separately. For the estimation of MWPC thresholds towards symptom improvement, different anchor-based and integrated approaches were used.

RESULTS: In total, the sample was composed of 357 patients with primary axillary hyperhidrosis. For the assessment of responsiveness, 5 out of 14 a-priori hypotheses regarding the correlation of the change scores could be confirmed, whereas the rejected hypotheses only marginally differed from the expected values. Furthermore, regarding responsiveness, the HidroQoL showed sensitivity towards symptom improvement at each measurement time point. Effect sizes were large as expected (d ≥ 0.806). MWPC thresholds towards symptom improvement were proposed for two measurement time points: 5 (week 4) and 6 (week 12). Increasing MWPC values over time were observed.

CONCLUSION: This study extends the evidence for the longitudinal validity of the HidroQoL up to 72 weeks and proposed MWPC thresholds for different time intervals (4 and 12 weeks) after baseline, aiding interpretability. Results concur with findings from previous validation studies.

PMID:39467334 | DOI:10.1093/bjd/ljae415

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Efficacy and safety of topical glycopyrronium bromide in treating axillary hyperhidrosis: systematic review and meta-analysis

Sci Rep. 2024 Oct 19;14(1):24537. doi: 10.1038/s41598-024-74430-4.

ABSTRACT

BACKGROUND: Hyperhidrosis (HH), characterized by excessive sweating, poses a significant challenge to patients’ quality of life. This meta-analysis evaluates the safety and efficacy of topical glycopyrronium bromide (GBP) in treating primary hyperhidrosis, a chronic condition affecting various body regions. Despite its prevalence, primary axillary hyperhidrosis is often undertreated due to a lack of awareness and social stigma.

METHODS: Following PRISMA guidelines, we conducted a systematic review and meta-analysis of randomized controlled trials comparing GBP to a placebo in primary hyperhidrosis patients. Eligibility criteria included outcomes related to perspiration suppression and symptom improvement.

RESULTS: Four RCTs involving 1401 patients were included. GBP significantly increased Hyperhidrosis Disease Severity Scale (HDSS) responders (RR = 2.33, 95% CI [1.99 to 2.74], p < 0.00001) and Axillary Sweating Daily Diary (ASDD/ASDD-C) responders (MD = 3.07, 95% CI [2.32 to 4.06], p < 0.002) without significantly causing adverse events. Dermatology life quality index was also significantly improved in the GBP group (MD = -2.32, 95% CI [-3.09, -1.55], P < 0.00001).

CONCLUSION: GBP demonstrated effectiveness in reducing sweat production while improving HDSS and DLQI scores. Adverse events included dry mouth and anticholinergic effects. Dry eye and local skin reactions were not significant, which makes GBP promising in managing primary hyperhidrosis, offering improvements in symptoms and quality of life. While adverse events should be considered, further research with larger sample sizes and long-term follow-up is warranted for comprehensive clinical integration.

PMID:39424822 | DOI:10.1038/s41598-024-74430-4

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Comparison of Microwave-Based Therapy and Negative-Pressure Suction-Curettage for Axillary Hyperhidrosis and Bromhidrosis: A Retrospective Analysis

Ann Plast Surg. 2024 Aug 1;93(2S Suppl 1):S86-S88. doi: 10.1097/SAP.0000000000003929.

ABSTRACT

BACKGROUND: Axillary hyperhidrosis and bromhidrosis are common clinical diseases, affecting the patients’ work and life. Negative-pressure suction-curettage is the most popular treatment now, but challenged by a new microwave-based therapy (MiraDry). We intend to compare the safety and efficiency of the 2 treatments.

METHODS: A retrospective analysis of 39 female patients with both primary hyperhidrosis and bromhidrosis was conducted. Seventeen patients were treated with MiraDry, and 22 underwent negative-pressure suction-curettage. The postoperative follow-up program included sweat and odor assessments, satisfaction measurement, safety evaluation, and recurrence assessment at different time points until 12 months.

RESULTS: Both treatments showed a significant reduction (P < 0.05) in HDSS score and odor level at 6 and 12 months compared with the baseline. No significant difference in relative reduction was observed between the 2 groups. The satisfaction score of the microwave-based therapy group was higher than that of the negative-pressure suction-curettage group, but no statistical difference was found. The difference in the recurrence rate and complication rate between the groups did not reach significance.

CONCLUSIONS: Microwave-based therapy is a noninvasive treatment with durable effects, low risks, shorter downtime, good appearance, and high satisfaction for axillary hyperhidrosis and bromhidrosis.

PMID:39101854 | DOI:10.1097/SAP.0000000000003929

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Hyperhidrosis and Neurofibromatosis Type 1: A Case Report

Cureus. 2024 Jun 24;16(6):e63021. doi: 10.7759/cureus.63021. eCollection 2024 Jun.

ABSTRACT

In this report, we present the case of a 20-year-old male with childhood-onset hyperhidrosis affecting his fingers and palm flexor surfaces. Dermatological examination revealed café-au-lait macules, palm and sole involvement, and axillary freckling. A starch-iodine test confirmed localized sweating. Neuroimaging identified neurofibromatosis type 1 (NF1) with subcutaneous nodules and dural ectasia in the thoracic spine. The patient was diagnosed with hyperhidrosis and NF1 based on diagnostic criteria, and he responded well to 20% aluminum chloride for treatment of hyperhidrosis. This case represents a unique occurrence of hyperhidrosis with NF1 in Saudi Arabia. Comprehensive evaluation, including systemic assessment, radiology, and starch-iodine testing, aids in diagnosis and understanding of the underlying mechanisms of this disorder, which remains unexplained.

PMID:39050311 | PMC:PMC11267592 | DOI:10.7759/cureus.63021

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Treatment of Primary Axillary Hyperhidrosis with Two Doses of Botulinum Toxin A-Observational Study

Toxins (Basel). 2024 Jul 16;16(7):320. doi: 10.3390/toxins16070320.

ABSTRACT

Hyperhidrosis (HH) is defined as the production of more sweat than is necessary for its thermoregulatory function, negatively affecting patients’ quality of life and interfering with their social, work and family life. In this context, the aim of thisstudy was to evaluate the efficacy of two different doses of botulinum toxin type A (50 or 100 units) in each axilla in severe primary axillary hyperhidrosis. A descriptive, observational, cross-sectional and post-authorisation study was conducted onpatients referred to our department.Thirty-one patients with severe primary axillary hyperhidrosis were included, some of whom received more than one infiltration during the follow-up period, performing a total of 82 procedures. They were assigned by simple random sampling to two types of treatment: infiltration of 50 or 100 units (U) of botulinum toxin A per axilla.Hyperhidrosis severity was assessed using the Hyperhidrosis Disease Severity Scale (HDSS), and quality of life was assessed using the Dermatology Life Quality Index (DLQI) questionnaire. Onabotulinum toxin A infiltration reduced the severity of hyperhidrosis and improved the quality of life of the treated patients, with no significant differences between the two groups.

PMID:39057960 | DOI:10.3390/toxins16070320

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Internalized stigma, disease severity, quality of life, anxiety and depression in axillary hyperhidrosis

Ann Dermatol Venereol. 2024 Jul 15;151(3):103291. doi: 10.1016/j.annder.2024.103291. Online ahead of print.

ABSTRACT

BACKGROUND: Axillary hyperhidrosis (AH) is characterized by excessive underarm sweating. It is a chronic autonomic disorder that can lead to social embarrassment, impaired quality of life (QoL), anxiety and depression. Internalized stigma (IS), defined as the acceptance of negative societal attitudes and stereotypes about an individual’s illness, has not been previously studied in AH. The aim of this study was to evaluate the level of IS in patients with AH and the relationships between IS, disease severity, quality of life, anxiety, and depression.

PATIENTS AND METHODS: One hundred and four patients with AH were included in the study. Demographic and clinical characteristics of the patients were recorded. The Hyperhidrosis Disease Severity Scale (HDSS) was used to define disease severity. Assessment was made using the Internalized Stigma Scale (ISS) (between 29 and 116, the higher the score the greater the stigma), Hospital Anxiety and Depression Scale (HADS) and Dermatology Life Quality Index (DLQI).

RESULTS: The mean age of the patients was 34.1 ± 10.9 years. The HDSS grade was mostly moderate to severe. The mean ISS score was 57.5 ± 6.5. Median HADS scores were 7 [interquartile range (IQR) 2-12] and 5 [IQR 2-10], respectively. HADS scores ≥ 8 were observed respectively in 39.4% and 8.7% of patients. The median DLQI score was 14 [IQR 4-24]. A DLQI score ≥ 11 was observed in 75% of patients. Significant correlation was found between ISS score and HDSS (r = 0.445, p < 0.001), HADS-A (r = 0.455, p < 0.001), DLQI (r = 0.478, p < 0.001) scores and symptom duration (r = 0.207, p = 0.035). The relationship between ISS and HADS depression scores was not statistically significant.

CONCLUSION: IS is common in patients with AH. Disease severity, symptom duration and anxiety increased IS. Patient’s quality of life is reduced in AH.

PMID:39013257 | DOI:10.1016/j.annder.2024.103291

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Long-term efficacy of fractional microneedle radiofrequency versus botulinum toxin-A in primary axillary hyperhidrosis: a randomized controlled trial

Lasers Med Sci. 2024 Jul 10;39(1):177. doi: 10.1007/s10103-024-04115-x.

ABSTRACT

Primary axillary hyperhidrosis is an idiopathic disorder that creates severe psycho-social burden due to excessive uncontrolled sweating. Various therapeutic agents have been described, but each has its own limitations. The use of fractional microneedling radiofrequency has emerged lately with promising results. This study aimed to determine the efficacy and safety of fractional microneedle radiofrequency in comparison to Botulinum toxin-A (BT-A) in patients with primary axillary hyperhidrosis. In this randomized controlled clinical trial, 20 patients (40 sides) were randomized to either fractional microneedle radiofrequency (4 sessions at 3-week intervals) or BT-A (single session), where each side received one of the treatment modalities. Efficacy was measured at 3, 6 and 12 months using Minor’s starch iodine test, HDSS score, Hqol questionnaire, and patient satisfaction. Fractional microneedle radiofrequency, although showed moderate efficacy, is inferior to BT-A regarding longitudinal efficacy at 12 months, as well as patients’ satisfaction. Both treatment modalities showed to be equally safe, but fractional microneedle radiofrequency procedure was substantially more painful. In conclusion, fractional microneedle radiofrequency does not offer a better substitute to BT-A in primary axillary hyperhidrosis. BT-A shows higher efficacy, is less painful, less expensive, and needs a smaller number of sessions.

PMID:38981914 | DOI:10.1007/s10103-024-04115-x