A Polymer Film Device to Treat Excessive Palmar Sweating

Launched by MILLER BIOSCIENCES LLC · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for excessive sweating on the palms, a condition known as palmar hyperhidrosis. This condition can be very challenging to manage and can affect daily activities, such as shaking hands or working with tools. The treatment being tested involves a special topical adhesive that quickly forms a protective layer on the skin to help reduce sweating. The goal is to see if this new treatment is safe and effective compared to existing options, which can be expensive or have uncomfortable side effects.

To participate in the trial, you need to be at least 18 years old and have had excessive sweating in your palms for at least six months. You'll also need to agree to follow the study guidelines. Participants will apply the treatment and be monitored for its effectiveness and any side effects. This trial is currently recruiting participants, and those who qualify may find a new and potentially better way to manage their excessive sweating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: Participants must meet all of the following criteria to be eligible for study participation:
• • 1. Signed informed consent.
• • 2. Age ≥ 18 years.
• • 3. Willing to comply with the protocol.
• • 4. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.
• • 5. Primary palmar hyperhidrosis for at least 6 months duration.
• • 6. Average sweat severity score of ≥ 3 at Baseline. Subjects must complete at least 4 days of the sweat severity NRS within 7 days of the Baseline visit.
• • 7. HDSS of 3 or 4 at Baseline.
• • 8. 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 of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), have been diagnosed as infertile, have same gender sex partner, are pre-menarche or are post-menopausal for at least 1 year. Hormonal contraception exclusively for study participation may be prohibited for minor female subjects according to local law and medical practice. Acceptable methods of birth control include: abstinence, oral contraceptives, contraceptive patches/implants; injectable contraceptives, double barrier methods (e.g., condom and spermicide) or an intra-uterine device (IUD). Birth control methods must have been stable/unchanged for 12 weeks prior to baseline and must remain unchanged during study participation.
• • 9. 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.
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• Exclusion Criteria: Participants meeting any of the following criteria are not eligible for study participation:
• • 1. Subjects who have taken or are currently taking Qbrexza (glycopyrronium) 2.4% within 4 weeks of baseline
• • 2. Prior surgical procedure for hyperhidrosis.
• • 3. Iontophoresis for the palms within 4 weeks of Baseline.
• • 4. Treatment with botulinum toxin (e.g., Botox) for palmar hyperhidrosis within 6 months of Baseline.
• • 5. Subjects 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.
• • 6. Subjects 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.
• • 7. 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 dosing has been stable for at least 4 months prior to Baseline and is not expected to change over the course of the study (inhaled anti-cholinergic drugs or beta agonists are allowed).
• • 8. 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 Baseline.
• • 9. Current pregnancy or lactation.
• • 10. Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
• • 11. 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, hyperthyroidism).
• • 12. Screening clinical chemistry or hematology laboratory (if medically necessary) value that is considered clinically significant, in the opinion of the Investigator.
• • 13. Known history of Sjogren's syndrome or Sicca syndrome.
• • 14. 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 ulcerative colitis or myasthenia gravis.
• • 15. 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).
• • 16. Subjects 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 participation in the study.
• • 17. Subjects that have a known or suspected allergy to cyanoacrylates.
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