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New treatment option for Palmar Hyperhidrosis
Official title A Polymer Film Device to Treat Excessive Palmar Sweating
ClinicalTrials.gov ID: NCT06881394
What this study is testing
- What it's testing
- Perspiration or sweating is a normal physiological response to increased body temperature, environmental heat and humidity, emotions, nervousness, or physical exertion. Perspiration occurs when sweat is secreted from sweat glands, travels through sweat ducts and exits sweat pores to coat the skin's surface.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet all of the following criteria to be eligible for study participation:
- Signed informed consent.
- Age ≥ 18 years.
- Willing to comply with the protocol.
- Male or non-pregnant (negative urine pregnancy test in female people of child-bearing potential), non-lactating females.
You likely can't join if
- Participants meeting any of the following criteria are not eligible for study participation:
- people who have taken or are currently taking Qbrexza (glycopyrronium) 2.4% within 4 weeks of baseline
- Prior surgical procedure for hyperhidrosis.
- Iontophoresis for the palms within 4 weeks of Baseline.
- Treatment with botulinum toxin (e.g., Botox) for palmar hyperhidrosis within 6 months of Baseline.
- people who are actively participating in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever...
See the full eligibility criteria
- Participants must meet all of the following criteria to be eligible for study participation:
- Signed informed consent.
- Age ≥ 18 years.
- Willing to comply with the protocol.
- Male or non-pregnant (negative urine pregnancy test in female people of child-bearing potential), non-lactating females.
- Primary palmar hyperhidrosis for at least 6 months duration.
- Average sweat severity score of ≥ 3 at Baseline. people must complete at least 4 days of the sweat severity NRS within 7 days of the Baseline visit.
- HDSS of 3 or 4 at Baseline.
- If female and of childbearing potential, subject must be willing to use an accepted method of birth control during study participation and for 30 days after the last study drug application. Females are considered to be...
- If male, is vasectomized or agrees to use an accepted method of birth control with a female partner during study participation and for 7 days after the last study drug application. \-
- Participants meeting any of the following criteria are not eligible for study participation:
- people who have taken or are currently taking Qbrexza (glycopyrronium) 2.4% within 4 weeks of baseline
- Prior surgical procedure for hyperhidrosis.
- Iontophoresis for the palms within 4 weeks of Baseline.
- Treatment with botulinum toxin (e.g., Botox) for palmar hyperhidrosis within 6 months of Baseline.
- people who are actively participating in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline Visit.
- people who have had a change in a regimen of psychotherapeutic medication (change in drug, dose, frequency) or who have started a psychoactive medication within two months of Baseline visit.
- Treatment with medications having systemic anticholinergic activity, centrally acting alpha-2 adrenergic agonists (e.g., clonidine, guanabenz, methyl dopa), or beta-blockers within 4 weeks of the Baseline visit unless...
- Intravenous (IV), oral, or topical glycopyrrolate treatment or any systemic treatment with an anticholinergic medication such as atropine, belladonna, scopolamine, clindinium or hyoscyamine within 4 weeks prior to...
- Current pregnancy or lactation.
- Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
- Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse...
- Screening clinical chemistry or hematology laboratory (if medically necessary) value that is considered clinically significant, in the opinion of the Investigator.
- Known history of Sjogren's syndrome or Sicca syndrome.
- History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating...
- History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia with a ventricular rate greater than 100 (other than sinus tachycardia).
- people who are a poor medical risk because of other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for...
- people that have a known or suspected allergy to cyanoacrylates. \-
The study team makes the final eligibility decision.
Where it's taking place
- Bellaire, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bellaire, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.