Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT06881394
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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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06881394
Study Brief:
Protocol Section:
NCT06881394