A Phase 2 interventional study of Glycopyrronium 2.4 % Medicated Cloth in Palmar Hyperhidrosis, Hyperhidrosis and Sweat Gland Diseases, sponsored by Pariser, Robert J., M.D.. Completed at 1 site in United States. Open to participants aged 9 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Pariser, Robert J., M.D. · Phase 2, Interventional, and Treatment
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
This study will assess glycopyrronium cloth, 2.4% in patients with primary palmar hyperhidrosis and compare the efficacy and safety of various application methods in order to determine an optimal method for use in palmar hyperhidrosis. The study will assess four application methods (treatment groups). Data from these cohorts will be reviewed on a continuous basis, and the protocol may be amended to add one or more treatment groups if required to determine the optional conditions of drug application.
This study is open label and unblinded. The treatment groups will be enrolled in cohorts, with each cohort being filled before moving on to the next. Cohort A will be enrolled first, followed by B, C, and D. Each cohort will have 30 subjects. If there are multiple AEs of special interest, the medical monitor may stop enrollment of one or more cohorts or may prematurely terminate a cohort(s).
All visits for this study will be conducted virtually, using HIPAA compliant video conferencing technology. Investigational product (IP) will be shipped overnight to subjects that are deemed eligible for participation.
All subjects will sign an informed e-consent and undergo screening for study eligibility. Key criteria for entry are: primary palmar hyperhidrosis for at least 6 months, an average hand sweat severity score of ≥4 (NRS 0-10 pts) during the screening period. Exclusion criteria includes pregnancy or lactation, secondary hyperhidrosis, prior sympathectomy, open wounds or infection on the hands, and concomitant use of iontophoresis, botulinum toxin, experimental therapy, or unstable doses of anticholinergic medications. Subjects will only be allowed to enroll into one cohort.
Approximately 120 eligible subjects, ≥9 years of age will be enrolled to one of four treatment groups at the Baseline visit.
Cohort Table 1: Treatment Groups A 30 minutes residence time in cotton gloves n=30 B 30 minutes residence time under occlusion n=30 C Overnight in cotton gloves n=30 D Overnight under occlusion n=30
Subjects will be instructed on the application method and will apply study drug at home once each evening before going to bed for 28 days (+/- 2 days). Subjects will complete virtual visits to check for adverse events (AEs) and study drug compliance at Week 1, Week 2, and Week 4. Subjects will exit the study at the Week 4 visit.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Pariser, Robert J., M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following criteria to be eligible for study participation.
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Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for study participation.
Subjects who are a poor medical risk because of other systemic diseases or active, uncontrolled infections, or any other condition, which (in the judgement of the investigator) would put the subjects at unacceptable risk for participation in the study.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: 30 minutes residence time in cotton gloves 1. Complete daily diary. 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put cotton gloves on both hands. 9. Set timer for 30 minutes. 10. After 30 minutes, remove gloves and throw them away. Immediately wash hands thoroughly with warm water and soap, and dry them.
Drug: Glycopyrronium 2.4 % Medicated Cloth
Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: 30 minutes residence time under occlusion 1. Complete daily diary. 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put gloves on both hands. 9. Set timer for 30 minutes. 10. After 30 minutes, remove gloves and throw them away. Immediately wash hands thoroughly with warm water and soap, and dry them.
Drug: Glycopyrronium 2.4 % Medicated Cloth
Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: Overnight in cotton gloves 1. Complete daily diary 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put on the cotton gloves on both hands and go to bed. 9. In the morning, after at least 4 hours of wearing the gloves , remove the cotton gloves and throw them away. 10. Immediately wash hands thoroughly with warm water and soap, and dry them.
Drug: Glycopyrronium 2.4 % Medicated Cloth
Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: Overnight under occlusion 1. Complete daily diary 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put on the occlusive gloves and go to bed. 9. In the morning, after at least 4 hours of wearing the gloves, remove the occlusive gloves and throw them away. 10. Immediately wash hands thoroughly with warm water and soap, and dry them.
Drug: Glycopyrronium 2.4 % Medicated Cloth
The investigational product (glycopyrronium cloth, 2.4%) is a pre-moistened, medicated cloth towelette that comes in individually wrapped packets. Subjects will receive marketed Qbrexza, one box, containing 30 pouches.
Also known as: Qbrexza
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.
The hand sweat severity (HSS) item is a patient reported outcome, collected nightly, and is designed to measure the severity of palmar hyperhidrosis.
Time frame: 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).
Proportion of subjects who have a >2 grade improvement in HDSS from baseline to week 4.
Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.
Time frame: From Baseline to week 4.
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glycopyrrolate
Pariser, Robert J., M.D.