| Eligibility |
Inclusion Criteria:
- Male or female subject =9 to <17 years of age in good general health.
- Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a)
HDSM-Ax of 2 - 4 inclusive at both the Screening Visit (Visit 1) and Baseline Visit
(Visit 2). (b) Symptoms of axillary hyperhidrosis for greater than or equal to 6
months' duration prior to enrollment.
Exclusion Criteria:
- In the Investigator's opinion, any skin or subcutaneous tissue conditions of the
axilla(e), (i.e., the axillary area should be deemed otherwise "normal", besides the
hyperhidrosis diagnosis, and free of blisters, large boils or sinus tracts,
significant scarring or open wounds).
- Prior use of any prohibited medication(s) or procedure(s) within the specified
timeframe for the treatment of axillary hyperhidrosis: (a) Botulinum toxin to the
axillary area within 9 months of enrollment. (b) Axillary thermolysis, sympathectomy
or surgical procedures of the axillary area at any time in the past. (c) Serotonergic
agonist (or drugs that increase serotonin activity including SSRIs), beta-blocker,
alpha-adrenergic agonist (clonidine), dopamine partial agonist or tricyclic
antidepressant treatment within 30 days of enrollment. However, if a subject has been
on a stable dose (in the opinion of the PI) of any of these medications and has not
had a recent change in hyperhidrosis frequency or severity for 3 months prior to
enrollment; they may be included. Doses of these agents should not be altered during
the course of the study. (d) Any topical treatment for hyperhidrosis, requiring a
prescription, within 3 days of enrollment.
- Anticholinergic agents [with the exception of sofpironium bromide] used to treat
conditions such as, but not limited to, hyperhidrosis, asthma, incontinence,
gastrointestinal cramps, and muscular spasms by any route of administration (e.g., IV,
oral, inhaled, topical) within 30 days of the enrollment.
- Use of potent oral inhibitors of cytochrome P450 CYP3A & CYP2D6 and transporter
inhibitors (OCT2/MATE1/MATE2) 14 days prior to enrollment. The use of topical
antifungal medications is permitted if not applied in the treatment area.
- Any oral or topical homeopathic or herbal treatment (i.e., alternative therapies such
as sage tablets, chamomile, valerian root and St. John's Wort) within 14 days of
enrollment.
- Use of any cholinergic drug (e.g., bethanechol) within 30 days of enrollment.
- Use of any anti-anxiety and/or anti-depressant, amphetamine product or drugs with
known anticholinergic side effects is prohibited with the following exceptions: (a) If
a subject has been on a stable dose of an anti-anxiety and/or anti-depressant drug and
has not had a recent change in hyperhidrosis frequency or severity for 3 months; they
may be included. (b) An amphetamine product may be allowed if the dose has been stable
for greater than or equal to 6 months without change in hyperhidrosis frequency or
severity for 3 months. (c) Drugs with known anticholinergic side effects (taken within
the last 30 days), including dry mouth, blurred vision, may be allowed based on the
Principal Investigator's assessment.
- Known causes of hyperhidrosis or known history of a condition that may cause
hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism,
diabetes mellitus, medications, etc.).
- Subjects with hyperhidrosis symptoms initiated or exacerbated with menopause.
- Subjects with unstable type 1 or type 2 diabetes mellitus or thyroid disease, history
of renal impairment, hepatic impairment, malignancy, glaucoma, intestinal obstructive
or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic
hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's
syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat
production or may be exacerbated by the use of anticholinergics in the Investigator's
opinion.
- Known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components
of the topical formulation.
- Subject is pregnant, lactating or is planning to become pregnant during the study.
- Unable or unwilling to undergo multiple venipunctures.
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