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

Phase 2

Completed

• Conditions: Hyperhidrosis
• Interventions: Other: Vehicle gel; Drug: BBI-4000, 15%

• Registration Number: NCT02682238
• Lead Sponsor: Botanix Pharmaceuticals

Brief 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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Study Start: 2016-03-08
• Primary Completion: 2016-07-14
• Study Completion: 2016-10-04
• Disposition First Submitted: 2018-07-17
• Disposition First Submitted QC: 2018-07-18
• Disposition First Posted: 2018-07-20
• Results First Submitted: 2022-12-15
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Results First Posted: 2023-05-19
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle gel	Vehicle (placebo) gel
BBI-4000, 15%	BBI-4000, 15%	15% BBI-4000 (sofpironium bromide) topical gel

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms	Baseline through day 29 (End of Treatment)	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.
Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29	Baseline to Day 29 (End of Treatment) Visit	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
Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm.	Baseline-Day 29 Participation	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.
The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms.	Baseline-Day 29 End of Treatment	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)\]

Trial Locations

Locations (5)

International Dermatology Research, Inc.; 🇺🇸 Miami, Florida, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

TCR Medical Corporation; 🇺🇸 San Diego, California, United States

Saint Louis University Dermatology; 🇺🇸 Saint Louis, Missouri, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States