A 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
Intervention description: BBI-4000 Gel, 5%; BBI-4000 Gel, 10%; BBI-4000 Gel, 15%; Placebo, BBI-4000 Gel, 0%
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when
      applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary axillary hyperhidrosis of at least 6 months's duration

          -  Hyperhidrosis disease severity score of 3 or 4 at baseline

          -  Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in
             each axilla, in 5 minutes (room temperature)

          -  Willing to refrain from using any other antiperspirant agent for the duration of the
             study.

          -  Females of childbearing potential must agree to use a medically acceptable method of
             contraception while participating in the study.

        Exclusion Criteria:

          -  Any skin or subcutaneous tissue conditions in the axilla or near the axillary area,
             other than hyperhidrosis.

          -  Prior use of any prohibited medication(s) or procedure(s) within the specified
             timeframe, including:

               1. Botulinum toxin to the axillary area within 1 year of the baseline visit.

               2. Axillary iontophoresis within 12 weeks of baseline visit.

               3. Axillary thermolysis, sympathectomy or surgical procedures of the axillary area
                  at any time in the past.

          -  Use of systemic and/or topical anticholinergic treatment within 30 days of the
             baseline visit.

          -  Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause.

          -  Subjects with history of diabetes mellitus, renal impairment, hepatic impairment,
             thyroid disease, 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.

          -  Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of
             the components of the topical formulation.

          -  Pregnant or lactating women.

          -  Use of an investigational drug within 30 days prior to the baseline visit.

          -  Prior treatment with the study drug in a previous trial.

          -  Any major illness within 30 days before the screening examination.

          -  Any other condition or laboratory abnormality that, in the judgment of the
             investigator, would put the subject at unacceptable risk for participation in the
             study or may interfere with the assessments included in the study.