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Botulinum Toxin-loaded Detachable Dissolvable Microneedles for Primary Axillary Hyperhidrosis: A Pilot Study on Efficacy and Safety

J Clin Aesthet Dermatol. 2025 Jan;18(1):E61-E66.

ABSTRACT

OBJECTIVE: Botulinum toxin injection is a well-established treatment for primary hyperhidrosis. The botulinum toxin-loaded detachable dissolvable microneedles (BoNT-MNs) were developed in a result of disadvantages of the intradermal procedure. This pilot study aims to evaluate the efficacy and safety of BoNT-MNs.

METHODS: This within-subject study included ten adults (N=10; 100% female) with mild primary axillary hyperhidrosis. BoNT-MNs patches were prepared and each microneedle patch contained 15 units of onabotulinum toxin. BoNT-MNs and placebo patches were randomly applied to different sides of axilla. Iodine-starch test, dermatologists’ and patients’ satisfaction scores were assessed at baseline and Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.

RESULTS: All ten female subjects completed the trial. Notably, on the BoNT-MNs side, iodine starch scores exhibited an onset at Week 2, with a 57.14-percent reduction at Week 12, returning to baseline after Week 20. Dermatologists’ and patients’ satisfaction scores were consistently superior to the placebo side from Week 2 and Week 1, respectively, until Week 16, with statistical significance (p<0.05) observed at Week 12 and Week 2.

LIMITATIONS: This study involved a limited number of female participants and administered a single, small dosage of botulinum toxin in the BoNT-MNs.

CONCLUSIONS: Botulinum toxin-loaded detachable dissolvable microneedles patches offer a safe and effective method for reducing axillary sweating.

CLINICAL TRIAL: This study was approved by the Institutional Review Board of Faculty of Medicine, Chulalongkorn University with IRB number 567/63, and registered in the Thai Clinical Trials Registry (Thaiclinicaltrials.org) under registration number TCTR20201230002.

PMID:39830825 | PMC:PMC11741174

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Comparative study between fractional laser assisted drug delivery of botulinum toxin versus botulinum toxin injection in primary palmar and axillary hyperhidrosis

Arch Dermatol Res. 2025 Jan 13;317(1):241. doi: 10.1007/s00403-024-03715-5.

ABSTRACT

Palmar hyperhidrosis is common condition that is challenging to treat. Nonsurgical treatments include topical antiperspirants, iontophoresis, anticholinergic drugs and botulinum toxin injections. To evaluate the safety and efficacy of ablative fractional laser therapy, combined with topically applied botulinum toxin versus its injection for the treatment of hyperhidrosis. This study included 40 patients with pimary hyperhydrosis divided into two groups. Group A (n = 20) diagnosed with primary axillary hyperhidrosis was further subdivided into 2 equal subgroups; for which was used fractional laser assisted drug delivery of botulinum toxin in right axilla and botulinum toxin injection in left axilla. Group B (n = 20) diagnosed with primary palmer hyperhidrosis was further subdivided into 2 equal subgroups; for which was used fractional laser assisted drug delivery of botulinum toxin in right palm and botulinum toxin injection in left palm. There was a statistically significant decrease in the hyperhidrosis disease severity scale (HDSS) in all subgroups after treatment as compared to before treatment. Following 3 months of treatment, the amount of sweat as detected by transepidermal water loss (TEWL) was statistically significantly lower in the injection subgroup in both the axillary group (p = 0.075) and the palmer group (p < 0.001). The use of both botulinum toxin injection and laser assisted botulinum toxin drug delivery were associated with significant improvement in the manifestation, disease severity and quality of life in the cases with both axillary and palmer hyperhidrosis. Fractional CO2 laser-assisted drug delivery (LADD) represents a safe, minimally invasive procedure that enhances the delivery of BTX-A.

PMID:39804494 | DOI:10.1007/s00403-024-03715-5

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Validation of new items for diagnosing primary hyperhidrosis and the prevalence of primary hyperhidrosis

Clin Exp Dermatol. 2025 Jan 10:llaf013. doi: 10.1093/ced/llaf013. Online ahead of print.

ABSTRACT

BACKGROUND: The Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis developed evidence-based consensus criteria for diagnosing primary hyperhidrosis.

OBJECTIVES: To validate new questionnaire items for self-reported classification of primary hyperhidrosis based on the consensus criteria and to estimate the prevalence of primary hyperhidrosis.

METHODS: This is a cross-sectional diagnostic accuracy study. Questionnaires containing the index tests and reference tests were distributed to blood donors at blood centers between June and December of 2021 in Region Zealand, Denmark. The index tests were the two questions ‘Have you had troublesome sweating?’ and ‘Have you ever had troublesome sweating?’, which were used to create six single-item algorithms for classifying primary hyperhidrosis. The reference test was the consensus criteria.

RESULTS: Overall, 1,071 (95.9%) of 1,083 eligible blood donors completed the index tests. The reference test classified 59 participants as having primary hyperhidrosis and 980 as not having primary hyperhidrosis, generating a prevalence of 5.7% (95% confidence interval 4.4-7.3%). The algorithms with the highest combined sensitivity and specificity were algorithm 2 with a sensitivity of 0.94 (95% confidence interval 0.77-0.99) and a specificity of 0.94 (confidence interval 0.92-0.95), and algorithm 5 with a sensitivity of 0.94 (95% confidence interval 0.80-0.99) and a specificity of 0.92 (confidence interval 0.90-0.94).

CONCLUSIONS: With high diagnostic accuracy, these items allow for the identification of individuals with and without primary hyperhidrosis, which may prove useful in epidemiological research. Validation in the general population is warranted.

PMID:39790068 | DOI:10.1093/ced/llaf013

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Radiofrequency Microneedling in Treating Primary Hyperhidrosis: A Systematic Review and Meta-Analysis

Dermatol Surg. 2025 Jan 3. doi: 10.1097/DSS.0000000000004532. Online ahead of print.

ABSTRACT

BACKGROUND: Radiofrequency microneedling (RFM) is a potential treatment for primary hyperhidrosis. However, its efficacy is unclear, and treatment parameters and outcomes vary across studies.

OBJECTIVE: To understand the effect of RFM on treating primary hyperhidrosis, as measured by changes in the Hyperhidrosis Disease Severity Score (HDSS) before and after treatment, and to clearly define treatment settings most likely to optimize results.

MATERIALS AND METHODS: A systematic literature search utilizing Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted across PubMed, EMBASE, MEDLINE, Web of Science, and the Cochrane Library. Studies were evaluated for risk of bias via the ROBINS-I tool and Levels of Evidence/GRADE criteria. A random forest model identified RFM settings that predict HDSS score decrease.

RESULTS: Six publications met inclusion criteria. The level of evidence was classified as Grade B, indicating moderate quality. RFM intervention resulted in a mean HDSS score decrease of 1.63 (52% reduction, p < .05). The strongest predictors for HDSS score decrease were dwell time, energy, and depth, with feature importances of 0.43, 0.19, and 0.15 respectively.

CONCLUSION: Radiofrequency microneedling treatment significantly reduces HDSS scores in patients with primary hyperhidrosis. Moving forward, it would benefit physicians to standardize objective protocols in reporting RFM parameters and measuring outcomes.

PMID:39761372 | DOI:10.1097/DSS.0000000000004532

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Evaluation of Efficacy and Safety of miraDry() Procedure in the Treatment of Primary Axillary Hyperhidrosis

Aesthetic Plast Surg. 2025 Jan 3. doi: 10.1007/s00266-024-04558-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Primary axillary hyperhidrosis significantly impacts the quality of life of affected individuals. miraDry®, a non-invasive local precisely controlled thermal energy procedure, represents a promising treatment option. This retrospective analysis aimed to evaluate the treatment success and patient safety following miraDry® procedure in the treatment of primary axillary hyperhidrosis.

MATERIAL AND METHODS: A total of 139 patients receiving miraDry® procedure from 2019 to 2023 with miraDry® fresh protocol for treatment of excessive axillary hyperhidrosis were analyzed. Subjective assessment was performed before and after treatment using hyperhidrosis disease severity scale (HDSS). Minor test (iodine starch test) was done before treatment and 6 months after treatment to objectively quantify sweat severity. Patients with subjective or objective unsatisfied results after first procedure were scheduled for a second treatment.

RESULTS: The majority of treated patients (84%) could effectively be treated with one single treatment, while only 16% (n = 22) required a secondary intervention. HDSS after treatment completion (single and double treatment) showed a significant improvement (p < 0.001) in subjective evaluation of the treatment success. Minor tests demonstrated a significant reduction in sweat severity (p < 0.001), with 95% of patients experiencing no or minimal sweating after treatment completion. The miraDry® procedure demonstrated a favorable safety profile with typical and transient treatment reactions that mostly resolved within 6 months (94.2%) CONCLUSION: Our data demonstrate that miraDry® procedure is an effective and safe treatment option for primary axillary hyperhidrosis, which results in an immense improvement in quality of life and high satisfaction of affected individuals.

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:39753871 | DOI:10.1007/s00266-024-04558-1

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CT-guided radiofrequency neurotomy (RFN) of bilateral T3-4 sympathetic chain combined with bilateral L3 sympathetic ganglion in patient with palmar hyperhidrosis

J Surg Case Rep. 2024 Dec 27;2025(1):rjae808. doi: 10.1093/jscr/rjae808. eCollection 2025 Jan.

ABSTRACT

Palmoplantar hyperhidrosis is a functional disease with an unknown pathogenesis, making it challenging to find a lasting and effective treatment. This article reports a case of a 43-year-old patient with palmoplantar hyperhidrosis treated with computed tomography (CT)-guided radiofrequency neurotomy (RFN) of bilateral T3-4 sympathetic chain combined with bilateral L3 sympathetic ganglion. The optimal puncture level and skin entry point were selected, and measurements were taken using a CT tool to determine needle depth, angle, and distance from the midline. A sympathetic needle was inserted through the T4 intercostal space to the outer side of the T4 rib head. The needle position was adjusted to achieve a tissue resistance, confirmed through sensory, motor stimulation, and three-dimensional reconstruction. RFN was performed, and this process was repeated for 1-2 cycles. Subsequently, a similar procedure was performed at the L3 sympathetic ganglion under CT guidance, resulting in improved sweating symptoms in the patient’s hands and feet.

PMID:39735332 | PMC:PMC11670927 | DOI:10.1093/jscr/rjae808

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Comparing Compensatory Sweating After Video-Assisted Thoracoscopic Sympathectomy: (T2-3) Versus (T2-4) Levels for Treating Palmar Hyperhidrosis

Cureus. 2024 Nov 20;16(11):e74077. doi: 10.7759/cureus.74077. eCollection 2024 Nov.

ABSTRACT

INTRODUCTION: Primary hyperhidrosis is a disease that is characterized by excessive sweating beyond what is required to maintain the normal temperature of the body. Moreover, it has a great adverse effect on the life of the affected persons because of problems in their social lives. There are different modalities to treat primary hyperhidrosis, including medical and surgical treatment. However, in sympathectomy, there is still a lack of strong evidence regarding which level should be targeted to achieve maximum benefit with fewer complications.

METHODS: This prospective clinical study was conducted at the Cardiothoracic Surgery Department, Alexandria Main University Hospital, Alexandria, Egypt, from September 2021 to Jan 2022. The study involved a total of 50 eligible consecutive patients who had bilateral primary palmar hyperhidrosis managed by bilateral, bi-portal, and tubeless thoracoscopic approach with conventional general anesthesia. Group A represents 25 patients with 13 males (52%) who had sympathetic chain cutting at the level of T2-3, and group B represents 25 patients with 15 males (60%) who had sympathetic chain cutting at the level of T2-4. The effect on palmar hyperhidrosis, compensatory hyperhidrosis, and overall patient satisfaction was assessed on the Visual Analog Scale (VAS).

RESULT: Ninety-eight percent of patients in both groups showed postoperative complete dryness of the hand and improvement of their symptoms. There was a statistically significant (p<0.001) difference regarding the degree of severity of compensatory sweating post-operatively between both groups. In group A, 44% of patients had compensatory sweating, while in group B, 96% of patients had symptoms of compensatory sweating with varying degrees from 1 to 5 on a VAS-Score of five degrees.

CONCLUSION: The level of cauterization has no significant effect on palmar hyperhidrosis dryness after cutting the sympathetic chain at level (T2-3) vs. (T2-4). However, the greater the number of levels that are cauterized, which are three levels rather than two, the more severe the compensatory sweating in this study.

PMID:39712769 | PMC:PMC11661883 | DOI:10.7759/cureus.74077

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Efficacy and safety of sofpironium in treatment of primary hyperhidrosis: a systematic review

J Dermatolog Treat. 2025 Dec;36(1):2441258. doi: 10.1080/09546634.2024.2441258. Epub 2024 Dec 13.

ABSTRACT

BACKGROUND: Primary axillary hyperhidrosis has limited noninvasive and effective treatment, and we present the use of sofpironium bromide as a promising treatment option. We aimed to assess the efficacy and safety of sofpironium in patients with primary hyperhidrosis.

METHODS: We systematically searched the databases for Studies that assessed sofpironium bromide in patients with primary axillary hyperhidrosis. Methodological quality was determined using the Cochrane Risk of Bias Assessment tool and Newcastle-Ottowa scale.

RESULTS: Five studies were included (752 patients). They used 5% sofpironium, except for one study that used 5%, 10%, and 15% sofpironium. Studies have shown a significant difference in the incidence of patients with an HDSS score of 1 or 2 ranging from 53.9% to 86.7% and reported a greater reduction in the mean change in the DLQI score in the sofpironium group. They also noted a more significant reduction in the total gravimetric weight of sweat in the sofpironium group. A 1.5 point or greater improvement in HDSM-Ax score ranged from 48.2% to 69.1%. Serious adverse events were not observed in the intervention group.

CONCLUSION: Sofpironium gel provides notable improvements in symptom severity, sweat reduction, and quality of life, with mostly mild localized adverse events.Hyperhidrosis is relatively common, affecting 4.8% of the US population and negatively affects physical, social, and psychological well-being.Sofpironium bromide is recently approved by the FDA for the treatment of primary axillary hyperhidrosisSofpironium bromide showed promising results in terms of safety and efficacy for treating hyperhidrosisWe systematically assessed the use of sofpironium gel reported in five studies (752 patients)Sofpironium gel provides notable improvements in symptom severity, sweat reduction and quality of life, with mostly mild localized adverse events.

PMID:39668771 | DOI:10.1080/09546634.2024.2441258