A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Sofpironium Bromide Gel, 15%
Intervention description: Sofpironium Bromide Gel, 15%
Intervention MeSH terms: Bromides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 9 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits,
      hands, and feet) affects approximately 4.8% of the US population and is believed to be caused
      by an overactive cholinergic response of the sweat glands. Sofpironium bromide (BBI-4000) is
      a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2
      study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of
      sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
    

Eligibility criteria:

        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.