A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: BBI-4000, 15%; Vehicle gel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle
      (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary palmar hyperhidrosis

          -  HDSS of 3 or 4 at baseline

          -  Gravimetric test at baseline indicating at least 100 mg of sweat production at rest in
             each palm and a sum of at least 250 mg in both palms, in 5 minutes (room temperature)

          -  Symptoms of at least 6 months' duration

          -  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 of the palms, other than hyperhidrosis

          -  Prior use of any prohibited medication(s) or procedure(s) within specified timeframe
             for the treatment of palmar hyperhidrosis, including:

               1. Botulinum toxin to the palmar area within 9 months of baseline visit

               2. Iontophoresis within 30 days of baseline visit

               3. Palmar thermolysis, sympathectomy or surgical procedures of the palmar area any
                  time in the past

               4. Serotonergic agonist within 30 days of baseline visit

               5. Any topical prescription treatment for hyperhidrosis within 30 days of baseline
                  visit

               6. Any over-the-counter topical antiperspirant/deodorant within 7 days of baseline
                  visit

          -  Use of anticholinergic agents within 30 days of baseline visit

          -  Any oral or topical homeopathic or herbal treatment within 30 days of baseline visit

          -  Use of any cholinergic drug within 30 days of baseline visit

          -  Use of any anti-anxiety and/or anti-depressant, amphetamine products or drugs with
             known anticholinergic side effects

          -  Hyperhidrosis secondary to any known cause

          -  Subjects with history of 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.

          -  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.

          -  Any major illness within 30 days before the screening examination.