A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar Hyperhidrosis. Participating subjects will apply either BBI-4000 15% or vehicle gel topically to the palms of both hands once daily for 4 consecutive weeks. The 4 week treatment period will be followed by a 2 week follow-up period. Safety and tolerability will be assessed through collection of vital signs, adverse events, assessment of local skin responses, ECG, UPT and blood sampling. Efficacy will be assessed through gravimetric sweat assessments as well as through the Hyperhidrosis Disease Severity Scale (HDSS).

Official Title
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A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects With Palmar Hyperhidrosis

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: BBI-4000, 15%
* Other: Vehicle gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBI-4000, 15%<br>15% BBI-4000 (sofpironium bromide) topical gel | Drug: BBI-4000, 15%<br> <br> |
| Placebo Comparator: Vehicle<br>Vehicle (placebo) gel | Other: Vehicle gel<br> <br> * Other names: Placebo gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Emergent Adverse Events by Severity | Each subject counted only once. Severity was rated Mild, Moderate or Severe. | Baseline visit-Day 42 End of Participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29 | HDSS assessment included a progressive hyperhidrosis severity scale, in which participants would rate the severity of their palmar hyperhidrosis for the past week with one of the following: 1-My sweating is never noticeable and never interfered with my daily activities; 2-My sweating is tolerable but sometimes interferes with my daily activities; 3-My sweating is barely tolerable and frequently interferes with my daily activities; 4-My sweating is intolerable and always interferes with my daily activities | Baseline to Day 29 (End of Treatment) Visit | 
| Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm. | Individual Right and left palm gravimetric measured sweat production results (mg) were combined per participant at Baseline and Day 29 time points. Mean averages of individual absolute GMSP changes (Day 29 Combined GMSP-Baseline Combined GMSP) were compared between the two treatment arms. | Baseline-Day 29 Participation | 
| Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms | Visit combined sweat production (mg) was calculated by combining individual right and left palm gravimetric sweat production results (mg) at Baseline and Day 29 time points. Resulting difference was calculated by: Day 29 Combined GMSP - Baseline Combined GMSP. Percent reduction in sweat production was calculated by: ((Resulting difference GMSP score (mg)) / Baseline GMSP score (mg) x 100). The number of subjects who achieved ≥ 50% reduction in sweat production (YES) were reported, along with the proportion=number of subjects who achieved ≥ 50% reduction in sweat production / total number of subjects providing baseline and day 29 results x 100. The number of subjects who achieved < 50% reduction in sweat production (NO) were reported, along with the proportion=number of subjects who achieved < 50% reduction in sweat production / total number of subjects providing baseline and day 29 results x 100. | Baseline through day 29 (End of Treatment) | 
| The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms. | Individual Right and left palm gravimetric sweat production (GMSP) results (mg) were combined per participant at Baseline and Day 29 time points. Mean averages of individual percent change were compared between the two treatment arms. Individual % Change vs. Baseline was determined by: [(D29 Right palm GMSP + D29 Left palm GMSP)-(Baseline Right palm GMSP + Baseline Left palm GMSP)]/(Baseline Right palm GMSP + Baseline Left palm GMSP)] | Baseline-Day 29 End of Treatment |