A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: BBI-4000 gel, 5%; BBI-4000 gel, 10%; BBI-4000 gel, 15%; Vehicle (Placebo)
Intervention description: BBI-4000 gel, 5% applied once to each axilla daily; BBI-4000 gel, 10% applied once to each axilla daily; BBI-4000 gel, 15% applied once to each axilla daily; Placebo, applied once to each axilla daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sweat gland disease; sweating; underarm

Summary:

      This study is being conducted to assess the safety and efficacy of 3 concentrations of
      BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject ≥ 18 years of age.

          -  Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a)
             symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c)
             HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of
             at least 150 mg.

          -  The ability to understand and follow all study-related procedures including study drug
             administration.

          -  Sexually active female of childbearing potential (FOCBP)* must agree to periodic
             pregnancy testing and use a medically acceptable method of contraception while
             receiving protocol-assigned product.

        Exclusion Criteria:

          -  In the Investigators opinion, any skin or subcutaneous tissue conditions of the
             axilla(s).

          -  Prior use of any prohibited medication(s) or procedure(s) within the specified
             timeframe for the treatment of axillary hyperhidrosis.

          -  Anticholinergic agents used to treat conditions such as, but not limited to,
             hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by
             any route of administration.

          -  Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6.

          -  Use of any cholinergic drug (e.g. bethanechol) within 30 days.

          -  Known cause 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 unstable diabetes mellitus or thyroid disease, history of renal or
             hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease,
             obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions,
             Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate
             sweat production by the use of anticholinergics in the investigator's opinion.

          -  Subjects with 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.

          -  History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial
             fibrillation or atrial flutter.