Category: Topical

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Sofpironium topical gel, 12.45%, for the treatment of axillary hyperhidrosis: pooled efficacy and safety results from 2 phase 3 randomized, controlled, double-blind studies

J Am Acad Dermatol. 2025 Mar 5:S0190-9622(25)00393-7. doi: 10.1016/j.jaad.2025.02.086. Online ahead of print.

ABSTRACT

BACKGROUND: Current treatments for primary axillary hyperhidrosis are insufficient for some patients. Sofpironium topical gel is a retrometabolically-designed topical anticholinergic with rapid metabolism, which is associated with reduced side effects and targeted efficacy.

OBJECTIVE: To assess efficacy and safety of sofpironium topical gel for primary axillary hyperhidrosis.

METHODS: Cardigan I and Cardigan II were double-blind, randomized, controlled pivotal phase 3 studies of sofpironium topical gel, 12.45%, versus vehicle gel (1:1 randomization) for daily application to the axillae for 6 weeks.

RESULTS: The combined Phase 3 studies included 353 subjects in the treatment groups and 348 subjects in the control groups. For the co-primary endpoint of ≥2-point improvement from baseline to end of treatment on Hyperhidrosis Disease Severity Measure-Axillary-7, pooled analyses showed significantly better results for treatment versus control (p<0.0001). For the pooled co-primary endpoint of gravimetric sweat production at treatment end, the treatment group had greater reduction in sweat production (p=0.0002). Secondary endpoints also showed a statistically significant benefit for sofpironium topical gel versus control. Treatment was well-tolerated.

LIMITATIONS: Short treatment and follow-up periods.

CONCLUSION: Sofpironium topical gel, 12.45%, applied topically once daily before bedtime is effective and well-tolerated for treatment of primary axillary hyperhidrosis in patients ≥9 years old.

PMID:40054501 | DOI:10.1016/j.jaad.2025.02.086

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Topical oxybutynin deodorant for axillary hyperhidrosis: a topic or a systemic effect? Rationale and design of the phase II today trial

J Vasc Bras. 2025 Feb 21;24:e20240098. doi: 10.1590/1677-5449.202400982. eCollection 2025.

ABSTRACT

Anticholinergics have been shown to enhance quality of life and reduce sweat in patients with hyperhidrosis. However, it remains unclear whether topical application specifically exerts local or systemic effects. This study’s primary aim is to assess topical oxybutynin’s impact on axillary hyperhidrosis. Twenty patients will be randomized into three groups. Group A will receive 2.5 mg of oral oxybutynin from day 1 to day 35 (on a variable frequency regimen). Group B will be administered a topical placebo for 35 days and Group C will receive a 10% oxybutynin topical spray, to be used twice daily for 35 days. The primary efficacy outcome will be the evaluation of the effectiveness of topical oxybutynin spray in treating hyperhidrosis. The TODAY trial will generate high-quality evidence on the effects of topical oxybutynin, assessing whether its impact is local or systemic in patients with axillary hyperhidrosis.

PMID:40012967 | PMC:PMC11864779 | DOI:10.1590/1677-5449.202400982

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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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Hyperocclusive technique for topical anesthesia for injecting botulinum toxin in palmar hyperhidrosis

J Cutan Aesthet Surg. 2024 Oct-Dec;17(4):335-336. doi: 10.4103/JCAS.JCAS_224_22. Epub 2023 Jun 27.

ABSTRACT

Injecting botulinum toxin under simple topical anesthesia using a eutectic mixture of lignocaine and prilocaine is a painful procedure. A simple hyper-occlusive modification in the existing technique of topical anesthesia of palms facilitates painless injections leading to greater patient satisfaction and compliance.

PMID:39649766 | PMC:PMC11619159 | DOI:10.4103/JCAS.JCAS_224_22

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Pharmacologic properties and results of a clinical study of oxybutynin hydrochloride lotion (APOHIDE() Lotion 20%) as a novel treatment for primary palmar hyperhidrosis

Nihon Yakurigaku Zasshi. 2024;159(6):413-422. doi: 10.1254/fpj.24037.

ABSTRACT

APOHIDE® Lotion 20% is a topical agent for treating primary palmar hyperhidrosis that contains the active ingredient oxybutynin hydrochloride. Oxybutynin hydrochloride has anticholinergic effects and inhibits sweating by binding to the M3 receptor, a subtype of the muscarinic acetylcholine receptor, in eccrine sweat glands. The clinical response to oxybutynin hydrochloride treatment also involves N-desethyloxybutynin, an active metabolite of oxybutynin. A clinical study in Japanese patients with primary palmar hyperhidrosis showed superiority of APOHIDE® Lotion 20% over placebo, i.e., there were significantly more responders (i.e., patients with a reduction in sweat volume ≥50% from baseline) in the APOHIDE® Lotion 20% group (APOHIDE® Lotion 20% group: 52.8%, placebo group: 24.3%; treatment difference: 28.5%; P < 0.001, Fisher’s exact test). This and other clinical studies reported some adverse events (AEs) associated with the drug’s anticholinergic effects and some application site AEs, but most of the AEs were mild. Clinical response did not decrease with long-term (52-week) treatment, and only a few patients (2 of 125) discontinued treatment because of AEs. Taken together, study results indicate that APOHIDE® Lotion 20% may be an effective and safe new treatment option for patients with primary palmar hyperhidrosis.

PMID:39496419 | DOI:10.1254/fpj.24037

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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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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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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