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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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Iontophoresis Improves the Impact on the Quality of Life of Children with Primary Hyperhidrosis-A Prospective Study and a Short Review

Children (Basel). 2024 Oct 17;11(10):1253. doi: 10.3390/children11101253.

ABSTRACT

BACKGROUND: Primary hyperhidrosis (PH) is a somatic and idiopathic pediatric skin disease. The eccrine glands are tiny and very numerous, with approximately 3 million distributed throughout the skin. There is no commonly accepted amount of sweating to define hyperhidrosis, but people with this disease suffer real limitations integrating into society, which can be quantified through quality of life measurement scales. We want to draw attention to this disease and its impact on children’s quality of life because it is significant and there are no studies conducted on groups consisting solely of children.

METHODS: There are various quality of life evaluation questionnaires for hyperhidrosis. We studied 103 children with hyperhidrosis by monitoring their sweat severity and its impact on quality of life, using the Hyperhidrosis Disease Severity Scale. We compared the scale results before and after 10 days of iontophoresis. This study includes only children under 18 years old, treated with iontophoresis.

RESULTS: The average age of the group is 11.84 ± 2.89 years. Treatment success is recorded in 68 (66.02%) children, but a change in the score is recorded in 74 (71.84%) children. The average HDSS score at T0 is 2.95 ± 0.70, compared to the HDSS score at T1 of 1.92 ± 0.86.

CONCLUSIONS: Hyperhidrosis has a negative impact on daily life, especially self-esteem, occupational productivity, emotional well-being, and interpersonal relationships. Iontophoresis is a safe and effective treatment method that reduces the severity of hyperhidrosis and increases the quality of life.

PMID:39457218 | DOI:10.3390/children11101253

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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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Sexual effects and long-term outcomes of endoscopic lumbar sympathectomy for plantar hyperhidrosis in men: a cross-sectional study

J Vasc Bras. 2024 Sep 27;23:e20240014. doi: 10.1590/1677-5449.202400142. eCollection 2024.

ABSTRACT

BACKGROUND: Plantar hyperhidrosis (PHH) is a disease with high psychosocial impact, and endoscopic lumbar sympathectomy (ELS) has been shown to be the best choice for treatment, but with some concerns such as compensatory sweating (CS) and sexual effects (SE), particularly in men.

OBJECTIVES: The aim of this study is to evaluate the long-term effectiveness of ELS for controlling PHH in men, its side effects, and perceived sexual modifications.

METHODS: A cross-sectional study including only male patients operated for PHH with ELS between 2014-2022 at a private practice. During remote interviews, patients were asked about symptoms before and after ELS and about the postoperative effects on PHH. They were also objectively asked about any SE during the postoperative period. Validated quality of life for hyperhidrosis and erectile function questionnaires were also administered.

RESULTS: 10 male patients averaging 4.26±2.86 years post-ELS were interviewed. Eight of them (80%) achieved complete response (≥80% of sweat reduction) in the first month after surgery and this response was maintained up to the interview date. Two patients had partial response. In six patients, CS occurred, with 5 reporting it as non-troublesome. Six patients reported some type of SE, but none reported erectile dysfunction. Regarding the functional results, all patients rated ELS from good (10%) to very good (30%) or excellent (60%).

CONCLUSIONS: Endoscopic lumbar sympathectomy was effective for treatment of plantar hyperhidrosis in these patients, improving their quality of life and providing lasting PHH control, with some transient sexual dysfunctions that did not impair their sexual life.

PMID:39421693 | PMC:PMC11486464 | DOI:10.1590/1677-5449.202400142

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Fractional CO(2) Laser-Assisted Delivery of Botulinum Toxin-A Versus Aluminum Chloride in Treatment of Primary Palmar Hyperhidrosis

Photodermatol Photoimmunol Photomed. 2024 Nov;40(6):e13006. doi: 10.1111/phpp.13006.

ABSTRACT

BACKGROUND: Primary palmar hyperhidrosis (PPH) constitutes a distressing dermatologic condition that greatly affects patients’ quality of life. Its management still needs to be addressed to find a suitable therapeutic modality that is readily available, cost effective, and gives patients a quite long disease-free period.

OBJECTIVE: To assess the efficacy of fractional CO2 laser as a delivery method for botulinum toxin-A (BTX-A) and aluminum chloride in treating PPH.

PATIENTS AND METHODS: Twenty-four subjects with PPH were treated on both hands with fractional CO2 laser followed on the right hand with topical BTX-A and on the left hand with topical aluminum chloride. Minor’s starch-iodine test and Hyperhidrosis Disease Severity Scale (HDSS) were used for evaluation of treatment response and for follow-up.

RESULTS: There was a significant improvement in HDSS in both groups, but there was no statistically significant difference in the therapeutic response for both modalities. There was a statistically significant longer disease-free period in the BTX-A-treated hands.

CONCLUSION: Fractional CO2 laser-assisted drug delivery (LADD) represents a safe, minimally invasive procedure that enhances the delivery of BTX-A and aluminum chloride, the two most widely used agents for treating PPH, with a comparable anhidrotic response.

PMID:39388586 | DOI:10.1111/phpp.13006