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
Comparison of the Efficacy of Tap Water Iontophoresis Versus Aluminum Chloride Hexahydrate in the Treatment of Palmoplantar Hyperhidrosis
Cureus. 2022 Dec 9;14(12):e32367. doi: 10.7759/cureus.32367. eCollection 2022 Dec.
ABSTRACT
OBJECTIVE: To compare the efficacy of tap water iontophoresis (TWI) versus aluminum chloride (AC) hexahydrate in the treatment of palmoplantar hyperhidrosis.
METHODS: The study was a randomized control trial performed at the dermatology department of Pakistan Navy Station (PNS) Shifa Hospital, Karachi from March 2022 to September 2022. A total of 70 palmoplantar hyperhidrosis patients were included in the study after getting approval from the ethical committee. Patients were divided into two groups. Group A patients were treated with TWI three times a week for four weeks. Group B patients were treated with a 20% AC topical solution applied at night to the affected areas for four weeks. The Hyperhidrosis Disease Severity Scale (HDSS) score for both groups was calculated at baseline, one, two, three, and four weeks. The final response was labeled at four weeks by comparing mean HDSS reduction in both groups. SPSS version 28 (IBM Corp., Armonk, NY) was used for data analysis.
RESULTS: Mean HDSS was compared for both groups at the end of the study, which showed a significant reduction in the mean score from 3.40 ± 0.65 to 1.48 ± 0.78 in group A, as compared to a decline in scores in group B from 3.28 ± 0.67 to 2.14 ± 0.94 (p = 0.002). In group A, zero, one, two, and three points HDSS improvement was 2.9%, 25.7%, 48.6%, and 22.9%, respectively. Whereas in group B, it was 34.3%, 22.9%, 34.3%, and 8.6%, respectively (p = 0.001).
CONCLUSION: As compared to AC topical solution, TWI is an effective, safe, and inexpensive management option for palmoplantar hyperhidrosis. It causes more improvement in HDSS scores and has lesser side effects.
PMID:36627989 | PMC:PMC9826940 | DOI:10.7759/cureus.32367
Long-term efficacy and safety of 1% glycopyrronium bromide cream in patients with severe primary axillary hyperhidrosis: results from a Phase 3b trial
J Eur Acad Dermatol Venereol. 2023 Jan 6. doi: 10.1111/jdv.18843. Online ahead of print.
ABSTRACT
BACKGROUND: Primary axillary hyperhidrosis (PAHH) strongly affects the patient’s quality of life. To date, topical treatment options are limited. 1% glycopyrronium bromide (GPB) showed promising efficacy and safety in a pivotal 4-week Phase 3a study.
OBJECTIVES: To assess efficacy and safety of topical 1% GPB cream in patients with severe PAHH in a long-term study of 72 weeks vs. baseline.
METHODS: This was a long-term, open-label, Phase 3b trial for 72 weeks including 518 patients with severe PAHH. Patients were treated with 1% GPB cream once daily for 4 weeks, followed by a flexible dosing scheme (min. twice per week, max. once daily). Primary endpoint was the absolute change in sweat production from baseline to week 12. Further study endpoints included assessment of the severity of PAHH and the impact on quality of life.
RESULTS: Total median sweat production decreased by 119.30 mg (-65.6%, both median) until week 12. Absolute change in sweat production from baseline to week 12 in logarithmic values was statistically significant (p < 0.0001). Patients’ quality of life was improved at all study time points compared to baseline, as assessed by Hyperhidrosis Quality of Life Index and Dermatology Life Quality Index (p < 0.0001). Treatment was safe and locally well-tolerated with only few mild to moderate adverse drug reactions (ADRs). Dry mouth and application site erythema were the most common reported ADRs.
CONCLUSIONS: Treatment with 1% GPB cream over 72 weeks significantly reduces sweat production and improves quality of life in patients with severe PAHH. 1% GPB cream is well-tolerated and provides an effective treatment option for long-term use in patients with severe PAHH.
PMID:36606529 | DOI:10.1111/jdv.18843
Efficacy, Safety and Quality of Life of Oxybutynin versus Aluminum Chloride Hexahydrate in Treating Primary Palmar Hyperhidrosis
Indian J Dermatol. 2022 May-Jun;67(3):222-227. doi: 10.4103/ijd.IJD_799_20.
ABSTRACT
BACKGROUND: Palmar hyperhidrosis is characterized by excessive sweating beyond the physiological needs of the patient’s body and the most frequent form is primary or essential. Different treatments protocols have been proposed to control or decrease sweating.
AIMS AND OBJECTIVES: This study aimed to compare the efficacy and safety of oral oxybutynin versus topical aluminum chloride hexahydrate (ACH) in treating primary palmar hyperhidrosis. Also, to assess quality of life (QOL) as a measure of improvement of hyperhidrosis state.
MATERIALS AND METHODS: Patients were randomized using the block randomization with sealed envelope method into two treatment groups; oral oxybutynin group and topical ACH group. Hyperhidrosis Disease Severity Scale (HDSS) was used as a primary outcome measure to assess the efficacy of the drug in both groups. Clinical grading and the QOL were used as secondary outcome measures. The safety was evaluated by recording side effects in the follow-up visits.
RESULTS: HDSS, clinical grading and QOL score showed a statistically significant improvement in the oral oxybutynin groups. One week after stoppage of treatment, the symptoms recurred again in both groups with return of HDSS and QOL scores to pretreatment levels. The most common side effects were dry mouth (65.8%) and itching (65.0%) for oral oxybutynin group and topical ACH group; respectively.
CONCLUSION: Treatment of primary palmar hyperhidrosis with oxybutynin is a good initial alternative for treatment given that it gives better results and much more improvement in QOL when compared to topical ACH. QOL questionnaire and clinical grading should also be considered as useful tools in the assessment of response to treatment.
PMID:36386101 | PMC:PMC9644765 | DOI:10.4103/ijd.IJD_799_20