Phase 2
N=50
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis
Hyperhidrosis
Bottom Line
View on ClinicalTrials.gov: NCT02682238 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Number of Treatment Emergent Adverse Events by Severity — 14; 4; 3; 0 Number of Events by Severity
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BBI-4000, 15% (Drug); Vehicle gel (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Botanix Pharmaceuticals
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events by Severity |
14; 4; 3; 0; 0; 0 | — |
| SECONDARY Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29 |
8; 6; 14; 17; 20; 21 | — |
| SECONDARY Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm. |
-91.38; -156.62 | — |
| SECONDARY Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms |
18; 18; 4; 5 | — |
| SECONDARY The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms. |
-10.56; -15.76 | — |
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:
- Botulinum toxin to the palmar area within 9 months of baseline visit
- Iontophoresis within 30 days of baseline visit
- Palmar thermolysis, sympathectomy or surgical procedures of the palmar area any time in the past
- Serotonergic agonist within 30 days of baseline visit
- Any topical prescription treatment for hyperhidrosis within 30 days of baseline visit
- 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.
Data sourced from ClinicalTrials.gov (NCT02682238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.