Dr. David M. Pariser discusses a multi-armed cohort study designed to offer guidance on off-label use of glycopyrronium cloth.
David M. Pariser, MD
Senior Physician, Virginia Clinical Research, Inc., Norfolk, Virginia
Results of an open-label study evaluating four regimens for using glycopyrronium 2.4% cloths (Qbrexa, Journey Medical Corporation) to treat palmar hyperhidrosis show that a 30-minute residence time while wearing cotton gloves produced the best efficacy followed closely by keeping the gloves on overnight. The latter regimen, however, was associated with far more adverse events.
“A randomized, vehicle-controlled study is needed to establish the true efficacy and safety of glycopyrronium cloth treatment for palmar hyperhidrosis. However, I regularly recommend that patients wipe their hands with the cloth until it is dry and then wear cotton gloves for 30 minutes,” said David M. Pariser, MD, who initiated the single-center study.
“It is extremely important that patients wash the hands thoroughly with warm water and soap after removing and discarding the gloves and avoid contact with the eyes. Despite frequent admonitions about the latter, a number of patients in our study developed unilateral mydriasis that fortunately resolved in a couple of days without intervention.”
An Off-label Use
Glycopyrronium 2.4% cloth is only approved for the management of primary axillary hyperhidrosis. However, the agent is often used off-label to treat hyperhidrosis affecting other body areas and particularly the palms, said Dr. Pariser.
“There are no published studies that could provide guidance on use of this product for palmar hyperhidrosis. To my understanding, a small study was conducted when the product was being developed, but the product was applied to the palms with a single wipe of the cloth.”
“In our study, patients were instructed to wipe the hands with the cloth until it was dry, which takes about 3 minutes. Our rationale for investigating the latter technique considered that it would require a larger dose to achieve efficacy given that the stratum corneum is thicker on the palms than the axillary skin,” he said.
To evaluate the efficacy and safety of different methods of using glycopyrronium cloth to treat palmar hyperhidrosis, Dr. Pariser and colleagues conducted an IRB-approved, telemedicine-based study. It included 120 patients aged ≥9 years who had self-classified excessive palmar sweating for at least 6 months and who were not using any concomitant treatments that could affect their palmar sweating.
Patients meeting those criteria entered a screening period during which they were asked to complete the Hand Sweat Severity (HSS) instrument nightly. Patients with an average score ≥4 (possible range 0 to 10) were randomized equally into four groups investigating: 15 minutes medication residence time in cotton gloves, 15 minutes residence time in cotton gloves, 30 minutes residence time under occlusion, and overnight residence in cotton gloves.
“We had no placebo control group and did not perform any statistical analyses. Our study cannot determine the true efficacy of glycopyrronium cloth for palmar hyperhidrosis nor was that its purpose,” said Dr. Pariser.
Analyzing the Findings
Mean change in average HSS during the week before randomization to the final week of treatment was analyzed as the primary endpoint. The change was greatest in the group with 30 minutes of residence time in cotton gloves (4.2) followed by overnight residence in cotton gloves (4.0). Mean change was 2.6 in the other two treatment groups.
Other patient-reported outcomes analyzed data collected during screening and at scheduled telemedicine visits using the Hyperhidrosis Disease Severity Scale (HDSS), Patient Impression of Severity, and Patient Impression of Change. The results for the 30-minute residence time in cotton gloves and overnight residence time were similar and best for those end points, and the protocol using occlusion was again associated with the least improvement.
“Perhaps occlusion caused increased sweating which diluted the drug and would have mitigated any treatment benefit,” said Dr Pariser, who also noted that all end points for all regimens showed increasing improvement over time, suggesting that patients may achieve further benefit from continuing use of the cloths beyond 4 weeks.
“We have no plans to conduct further research on this topic.”
All of the regimens were generally safe and well-tolerated. There were 67 adverse events judged related to the study drug. The greatest number of adverse events occurred in the group with overnight residence time and the fewest were in the group with the 15-minute residence time.
Patient-reported local skin reactions (e.g., burning, stinging, pruritus) and investigator-determined local skin reactions (e.g., edema, erythema, dryness, scaling) were generally mild and resolved despite continuation of treatment. One patient withdrew from the study because of burning and itching.
Signs and symptoms of systemic anticholinergic effects occurred in seven patients. One patient with blurred vision, urinary hesitancy, bilateral pupil dilation, dry mouth, and headache withdrew from the study. Another subject with bilateral pupil dilation that did not resolve after treatment was withheld for 3 days was withdrawn per the protocol.
Disclosure: Dr. Pariser is an investigator and consultant for Dermira/Lilly, which supported the study. Journey Medical acquired Qbrexa from Dermira/Lilly in 2021.
Reference
1. Pariser D, Rivera E, Benedict D. Open-Label Cohort Study to Evaluate Efficacy and Safety of Application of Glycopyrronium Cloth, 2.4% for Palmar Hyperhidrosis. J Drugs Dermatol. 2022;21(5):488-495. doi:10.36849/JDD.6688.
With Cheryl Guttman Krader
