Table 2.
Summary and risk of bias for anticholinergic agents.
Study and intervention | HH population and design | Risk of bias | Key results/critical appraisal findings |
---|---|---|---|
Glaser et al.16 Topical 2.4% glycopyrronium tosylate (GT) pre-moistened cloth vs. vehicle (same appearance and excipient content with exception of GT) |
Axillary Two distinct 4-week, randomized, double-blind, vehicle-controlled clinical trials in patients ≥ 9 years of age (N = 697) |
Low | Nearly 75% of patients achieved a ≥50% reduction from baseline in axillary sweat production and 59% achieved a ≥2-point reduction in HDSS score by week 4 with GT (pooled results) ∼60% of patients had ≥4-point improvement on Axillary Sweating Daily Diary Item 2, indicating a clinically meaningful improvement in disease severity, and 58.1% rated their condition as much better (Patient Global Impression of Change) with GT Safety: AEs occurring in ≥5% in either pooled group included dry mouth (24.2% GT vs. 5.6% vehicle), application site pain, mydriasis, oropharyngeal pain, and headache; local skin reactions were reported in 30.8% GT vs. 30.3% vehicle and were predominantly mild to moderate in severity |
Glaser et al.20 Topical 2.4% glycopyrronium tosylate (GT) pre-moistened cloth |
Axillary A 44-week observational open-label extension trial (N = 550) for those who completed the two trials described in Glaser 2018 |
N/A (used for safety only) | N/A for efficacy Safety: results were consistent with the findings in prior studies, with no new or unexpected findings; AEs were dry mouth (16.9%), blurred vision (6.7%), application site pain (6.4%), nasopharyngitis (5.8%) and mydriasis (5.3%) Long-term efficacy outcomes collected and supported findings in the two double-blind trials |
Hyun et al.24 2% topical glycopyrrolate-impregnated cotton pads (not commercially available) vs. placebo |
Facial Randomized, double-blind, placebo-controlled study for 9 days investigated in subjects aged 20–66 years with facial hyperhidrosis (N = 39) *Reevaluated based on W/P design: drug/placebo split application in two halves of forehead) |
Moderate | Compared with the placebo-treated sides, topical glycopyrrolate-treated sides showed a reduction in the rate of sweat production at the forehead of 36.68 ± 11.41% on day 10 (p<.025) Safety: one patient reported transient headache following treatment |
Artzi et al.23 Topical oxybutynin chloride 10% gel vs. placebo |
Axillary, palmar, plantar W/P, placebo-controlled comparison (2× daily application) with randomization for 4 weeks in adults (N = 61) *Newly identified relative to Wade et al.12 |
Moderate (LRR) | Palmar hyperhidrosis patients are likely to experience 25% to <50% sweat reduction as assessed by the minor starch-iodine test Approximately, three quarters (axillary), two thirds (palmar), and half (plantar) of patents reported a 1-point change in HDSS A 2-point HDSS change was reported by 9.5% (axillary), 8.3% (plantar), and 5% (palmar) Approximately, three quarters of patients reported moderate to high satisfaction Safety: Approximately, half of patients with axillary hyperhidrosis treated with oxybutynin 10% gel reported erythema and/or pruritus; patients have reported dry mouth, erythema, itching, a “sticky” feel and inconvenience of use |
Abbreviations. AE, Adverse event; GT, Glycopyrronium tosylate; HDSS, Hyperhidrosis Disease Severity Scale; LRR, Large response rates; W/P, Within patient.