Category: Topical

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Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study.

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Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study.

Pediatr Dermatol. 2020 Mar 08;:

Authors: Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM

Abstract
BACKGROUND/OBJECTIVES: Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients ≥9 years. This post hoc analysis evaluated long-term response (efficacy and safety) in pediatric patients (≥9 to ≤16 years) to GT in the 44-week, open-label extension (NCT02553798) of two, phase 3, double-blind, vehicle-controlled, 4-week trials (NCT02530281, NCT02530294).
METHODS: In the double-blind trials, patients ≥9 years with primary axillary hyperhidrosis were randomized 2:1 to once-daily GT:vehicle. Those who completed the study could receive open-label GT for up to an additional 44 weeks. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (≥2-grade improvement), and Children’s Dermatology Life Quality Index.
RESULTS: Of 43 pediatric patients completing either double-blind trial, 38 (88.4%) entered the open-label extension (age, years: 9 [n = 1], 12 [n = 2], 13 [n = 7], 14 and 15 [n = 9 each], 16 [n = 10]). The safety profile observed was similar to the double-blind trials. Most TEAEs (>95%) were mild/moderate, related to anticholinergic activity, and infrequently led to discontinuation (n = 1/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7 days. Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity. Improvements in efficacy measures were maintained from the double-blind trials.
CONCLUSIONS: Long-term, once-daily GT for up to 48 weeks (4-week double-blind plus 44 week open label) provides a noninvasive, well-tolerated treatment option for pediatric patients with primary axillary hyperhidrosis.

PMID: 32147881 [PubMed – as supplied by publisher]

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Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial.

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Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial.

J Am Acad Dermatol. 2020 Feb 14;:

Authors: Kirsch B, Smith S, Cohen J, DuBois J, Green L, Baumann L, Bhatia N, Pariser D, Liu PY, Chadha D, Walker P

Abstract
BACKGROUND: Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.
OBJECTIVE: To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.
METHODS: A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to one of three doses or vehicle, with daily treatment for 42 days. Coprimary endpoints were the percentage of participants exhibiting ≥1-point improvement in Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax; logistic regression), and change in HDSM-Ax as a continuous measure (ANCOVA). Pair-wise comparisons were one-sided with alpha=0.10.
RESULTS: At end-of-therapy, 70%, 79%, 76% and 54% of participants in the 5%, 10%, 15% and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P<0.05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P≤0.0001). Most treatment-related adverse events were mild or moderate.
LIMITATIONS: Not powered to detect changes in gravimetric sweat production.
CONCLUSION: Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

PMID: 32068049 [PubMed – as supplied by publisher]

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Pressure-and dose-controlled, needle-free, transcutaneous pneumatic injection of botulinum neurotoxin-A for the treatment of primary axillary and palmoplantar hyperhidrosis.

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Pressure-and dose-controlled, needle-free, transcutaneous pneumatic injection of botulinum neurotoxin-A for the treatment of primary axillary and palmoplantar hyperhidrosis.

Skin Res Technol. 2020 Jan 10;:

Authors: Kim HM, Lee MJ, Lee MH, Lee H

Abstract
BACKGROUND: Botulinum neurotoxin (BoNT) effectively downregulates the secretion of eccrine sweat glands in patients with axillary and palmoplantar primary hyperhidrosis (PH).
OBJECTIVE: To demonstrate the efficacy and safety of pressure- and dose-controlled, needle-free, transcutaneous pneumatic injection (TPI) of BoNT-A for treating axillary and palmoplantar PH.
METHODS: Needleless TPI-BoNT-A treatments were delivered on the axillary or palmoplantar skin at a pneumatic pressure of 2.05 bars and an injection volume of 0.08 mL/shot. The efficacy thereof was assessed by evaluating starch-iodine test results and Hyperhidrosis Disease Severity Scale (HDSS) scores.
RESULTS: At baseline, median HDSS scores were 3 (IQR, 3-4) for axillary lesions and 4 (IQR, 3.5-4) for palmoplantar lesions. Median HDSS scores at 1 month after TPI-BoNT-A treatment significantly decreased to 1 (IQR, 1-1.75) for axillary lesions (P < .001) and 1 (IQR, 1-2) for palmoplantar lesions (P < .001). Median global improvement scale scores were 4 (IQR, 3.25-4) for axillary PH and 3 (IQR, 2.5-4) for palmoplantar PH (P > .05). In all patients, pain was tolerable during treatments for both axillary and palmoplantar PH after the application of topical anesthetic cream.
CONCLUSION: Pressure- and dose-controlled, needle-free, BoNT delivery effectively and safely decreased sweating in axillary and palmoplantar skin.

PMID: 31922304 [PubMed – as supplied by publisher]

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Botulinum Toxin: Pharmacology and Injectable Administration for the Treatment of Primary Hyperhidrosis.

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Botulinum Toxin: Pharmacology and Injectable Administration for the Treatment of Primary Hyperhidrosis.

J Am Acad Dermatol. 2019 Dec 04;:

Authors: Nawrocki S, Cha J

Abstract
Hyperhidrosis is a dermatological condition defined by excessive sweating beyond thermoregulatory needs with significant effects on patients’ quality of life. Hyperhidrosis is categorized as primary or secondary: primary hyperhidrosis is mostly focal and idiopathic, whereas secondary hyperhidrosis is commonly generalized and caused by an underlying medical condition or use of medications. Various surgical and nonsurgical therapies exist for primary hyperhidrosis. Although botulinum toxin is one of the deadliest toxins known, when used in small doses, it is one of the most effective therapies for primary hyperhidrosis. Botulinum toxin injections are widely used as a second-line primary hyperhidrosis treatment option, when topical treatment strategies have failed. This article provides an overview of the commercially available botulinum toxin formulations and their applications for the treatment of primary hyperhidrosis.

PMID: 31811879 [PubMed – as supplied by publisher]

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Management Strategies Of Palmar Hyperhidrosis: Challenges And Solutions.

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Management Strategies Of Palmar Hyperhidrosis: Challenges And Solutions.

Clin Cosmet Investig Dermatol. 2019;12:733-744

Authors: Gregoriou S, Sidiropoulou P, Kontochristopoulos G, Rigopoulos D

Abstract
Palmar hyperhidrosis is a potentially disabling condition for which management remains a therapeutic challenge. Given the significant impact on quality of life, various treatment options are available, ranging from topical agents and medical devices to systemic therapies and surgical interventions. Nonsurgical approaches, i.e. topical antiperspirants, botulinum toxin injections, iontophoresis, and systemic agents, are all supported by the current literature. Patients with mild-to-moderate disease can often benefit from topical therapies only. As disease severity progresses, systemic oral medication, such as anticholinergic drugs, usually becomes necessary. Last-line surgical approaches (sympathetic denervation) should be reserved for severe refractory cases. Recently, therapeutic strategies have been evolving with several new agents emerging as promising alternatives in clinical trials. In practice, however, each modality comes with its own benefits and risks. An individual therapeutic ladder is generally recommended, taking into account disease severity, benefit-to-risk profile, treatment cost, patient preference, and clinician expertise. This review will provide an update on current and emerging concepts of management for excessive hand sweating to help clinicians optimize therapeutic decision-making.

PMID: 31632121 [PubMed]

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Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use.

Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use.

Clin Drug Investig. 2019 Sep 30;:

Authors: Lamb YN

Abstract
Glycopyrronium tosylate (Qbrexza™) is available as single-use, pre-moistened cloths and has been approved in the USA for the topical treatment of primary axillary hyperhidrosis in adults and children ≥ 9 years of age. Glycopyrronium tosylate is effective in reducing patient-reported severity of disease and gravimetrically measured sweat production in this patient population; improvements have been shown to be maintained throughout long-term treatment (up to 48 weeks). Glycopyrronium tosylate is generally well tolerated, with most adverse events being mild to moderate in severity. Glycopyrronium tosylate thus provides a self-administered, non-invasive alternative to topical antiperspirant therapy and clinic-based treatments in adults with primary axillary hyperhidrosis, and is the only alternative to topical antiperspirants specifically approved in children and adolescents ≥ 9 years of age.

PMID: 31571127 [PubMed – as supplied by publisher]