| Eligibility |
Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for study participation.
1. Subjects must provide fully executed informed e-consent and e-assent (if applicable)
prior to any study procedures.
2. Age = 9 years.
3. Willing to comply with the protocol, including completion of designated virtual study
visits and prescribed study treatment regimens.
4. 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.
5. 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.)
6. 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.)
7. Primary palmar hyperhidrosis for at least 6 months.
8. 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.
9. Females of childbearing potential must be willing to use an acceptable 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, or are postmenopausal for at least 1 year.
Acceptable methods of contraception 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 method
must have been stable/unchanged for 12 weeks prior to Baseline and must remain
unchanged during study participation and for 30 days after the last study drug
application.
10. Males must either have been vasectomized or agree to use an acceptable method of birth
control with female partners during study participation and for 30 days after the last
study drug application.
11. Subjects must agree not to donate eggs or sperm (as applicable) during the trial.
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Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for study participation.
1. Prior surgical procedure for hyperhidrosis.
2. Iontophoresis for the palms within 4 weeks of Baseline.
3. 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.)
4. 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.
5. 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.)
6. 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.
7. Current pregnancy or lactation per patient report.
8. Open wounds or inflammatory lesions on the hands, or any condition that may alter the
barrier function of the skin on the hands.
9. 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).
10. Known history of Sjögren's syndrome or Sicca syndrome.
11. 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.
12. Men with a history of urinary retention requiring catherization due to prostatic
hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
13. History of ventricular arrhythmias, atrial fibrillation, atrial flutter.
14. Subjects with known medical procedures or surgeries that are scheduled to occur during
the study.
15. 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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