An Open Label Study for Palmar Hyperhydrosis (NCT04906655) | Clinical Trial Compass
CompletedPhase 2
An Open Label Study for Palmar Hyperhydrosis
United States120 participantsStarted 2020-10-01
Plain-language summary
The purpose of this open-label study is to evaluate the efficacy and safety of different methods of application of glycopyrronium cloth, 2.4% in patients with palmar hyperhidrosis
Who can participate
Age range
9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must provide fully executed informed e-consent and e-assent (if applicable) prior to any study procedures.
. Age ≥ 9 years.
. Willing to comply with the protocol, including completion of designated virtual study visits and prescribed study treatment regimens.
. Subjects must have access to and the ability and willingness to use their own smart device (e.g., phone, computer, tablet). Subjects must have reliable internet access and video capabilities to conduct virtual visits, e-consent, and ePROs. Subjects must have an active email address that is password protected. Their password must remain confidential throughout the study.
. Subjects must have a street address to which study drug can be delivered and received in a timely manner. (PO Boxes will not be allowed.)
. Male or non-lactating and non-pregnant females (documentation of a negative urine pregnancy test done by the subject must be done prior to sending study drug.)
. Primary palmar hyperhidrosis for at least 6 months.
. Average sweat severity score of ≥4 at the end of screening. Subjects must complete the diary at least 4 times out of 7 days prior to baseline.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change of the average hand sweating score (Daily Diary Question 1) from the week of Screen-Baseline to the final week of study treatment.
Timeframe: From the week of Screen-Baseline (7 days prior to the end of the screening visit) to the final week of study treatment (week 4).
2
Proportion of subjects who have a >2 grade improvement in HDSS from baseline to week 4.
. Iontophoresis for the palms within 4 weeks of Baseline.
. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline. (Note: treatment with botulinum toxin in other areas is not exclusionary.)
. Subjects who are actively participating in an experimental therapy study or who received experimental therapy within 30 days of 5 half-lives (whichever is longer) of the Baseline Visit.
. For subjects that are taking concomitant medications that may have an effect on sweating (i.e., psychotherapeutic medications, centrally acting alpha-2 adrenergic agonists (e.g., clonidine, guanabenz, methyl dopa), or beta blockers, the dose must be stable, in the opinion of the investigator, for two months prior to Baseline. There should be no expected medication changes over the course of the study unless deemed to be medically necessary. (Note: inhaled anticholinergic drugs or beta agonists are allowed.)
. Intravenous (IV), oral, or topically glycopyrrolate treatment of any systemic treatment with an anticholinergic medication, such as atropine, belladonna, scopolamine, clindinium, or hyoscyamine within 4 weeks prior to Screening.
. Current pregnancy or lactation per patient report.
. Open wounds or inflammatory lesions on the hands, or any condition that may alter the barrier function of the skin on the hands.