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

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

Topical Anticholinergics in the Management of Focal Hyperhidrosis in Adults and Children: A Narrative Review

Actas Dermosifiliogr. 2023 Sep 13:S0001-7310(23)00733-0. doi: 10.1016/j.ad.2023.09.006. Online ahead of print.

ABSTRACT

Hyperhidrosis, or excessive sweating, is characterized by overactivity of the eccrine sweat glands, usually associated with dysfunction of the autonomic nervous system. Primary focal hyperhidrosis is the most common form and can affect the axillae, palms, soles, and/or face, often leading to significantly impaired quality of life and social functioning. Treatment is complex. Topical antiperspirants are normally recommended as the first-line treatment for mild hyperhidrosis. Multiple clinical trials and prospective studies support the efficacy and tolerability of oral and topical anticholinergics in the management of hyperhidrosis. Topical glycopyrronium, which has been investigated in at least 8 clinical trials enrolling more than 2000 patients, is probably the first-line pharmacological treatment for axillary hyperhidrosis in patients with moderate to severe disease poorly controlled with topical antiperspirants. Second-line treatments include botulinum toxin injections, microwave treatment, and oral anticholinergics. We review the use of topical anticholinergics in the management of focal hyperhidrosis in adults and children.

PMID:37714301 | DOI:10.1016/j.ad.2023.09.006

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

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

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

Oxybutynin gel versus nanoemulgel for treating primary palmar hyperhidrosis: A pilot double-blind randomized controlled trial

J Cosmet Dermatol. 2023 Mar 31. doi: 10.1111/jocd.15715. Online ahead of print.

ABSTRACT

INTRODUCTION: Palmar hyperhidrosis or excessive palmar sweating can reduce one’s quality of life as it is associated with significant physical and occupational disabilities. We compared the gel and nanoemulgel of oxybutynin in treating these patients.

MATERIALS AND METHODS: This pilot study was performed as a double-blind controlled randomized clinical trial at Shahid Faghihi Hospital, Shiraz, Iran. In two randomly allocated groups of 15, patients diagnosed with primary palmar hyperhidrosis by an attending dermatologist applied half a fingertip (roughly 0.25 g) of 1% oxybutynin topical gel or 1% oxybutynin nanoemulgel to both palms every 12 h for one month. The Hyperhidrosis Disease Severity Scale (HDSS), Visual Analog Scale (VAS), and Dermatology Life Quality Index (DLQI) were used to assess the patients at the beginning and end of the study. Statistical analysis was performed using SPSS version 25.

RESULTS: The groups were similar in terms of age (p = 0.800), sex (p = 0.096), and baseline HDSS, VAS, and DLQI scores. The mean HDSS scores decreased significantly (p = 0.001) over time in patients receiving the gel (3.00 ± 1.00 vs. 2.33 ± 0.61) or nanoemulgel (2.92 ± 0.82 vs. 2.14 ± 0.53), without a significant difference between the groups. The same was true for the VAS and DLQI scores. Three patients in each group experienced transient, self-limited anticholinergic side effects (p = 0.983).

CONCLUSION: Oxybutynin gel and nanoemulgel offer equal safety and similar efficacy in reducing the disease severity and increasing the quality of life of patients with palmar hyperhidrosis.

PMID:36999480 | DOI:10.1111/jocd.15715

A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study in Japan

J Am Acad Dermatol. 2023 Mar 27:S0190-9622(23)00511-X. doi: 10.1016/j.jaad.2023.03.025. Online ahead of print.

ABSTRACT

BACKGROUND: No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.

OBJECTIVE: To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).

METHODS: In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks. Palmar sweat volume was measured by the ventilated capsule method. For the primary outcome, response was defined as a reduction of sweat volume of at least 50% from baseline.

RESULTS: At week 4, the responder rate for sweat volume was significantly higher in the 20% OL arm than in the placebo arm (52.8% vs 24.3%, respectively; treatment difference, 28.5% [95% CI, 17.7 to 39.3%]; P < .001). No serious adverse events (AEs) occurred, and no AEs led to treatment discontinuation.

LIMITATIONS: The treatment period was only 4 weeks.

CONCLUSIONS: In patients with PPHH, 20% OL is superior to placebo in reducing palmar sweat volume.

PMID:36990320 | DOI:10.1016/j.jaad.2023.03.025