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

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BBI-4000, 15%
Vehicle gel
Sponsored by
Botanix Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • TCR Medical Corporation
  • International Dermatology Research, Inc.
  • Shideler Clinical Research Center
  • Saint Louis University Dermatology
  • Virginia Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BBI-4000, 15%

Vehicle

Arm Description

15% BBI-4000 (sofpironium bromide) topical gel

Vehicle (placebo) gel

Outcomes

Primary Outcome Measures

Number of Treatment Emergent Adverse Events by Severity
Each subject counted only once. Severity was rated Mild, Moderate or Severe.

Secondary Outcome Measures

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
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.
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.
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)]

Full Information

First Posted
February 10, 2016
Last Updated
May 18, 2023
Sponsor
Botanix Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02682238
Brief Title
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
July 14, 2016 (Actual)
Study Completion Date
October 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Botanix Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBI-4000, 15%
Arm Type
Experimental
Arm Description
15% BBI-4000 (sofpironium bromide) topical gel
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle (placebo) gel
Intervention Type
Drug
Intervention Name(s)
BBI-4000, 15%
Intervention Type
Other
Intervention Name(s)
Vehicle gel
Other Intervention Name(s)
Placebo gel
Primary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events by Severity
Description
Each subject counted only once. Severity was rated Mild, Moderate or Severe.
Time Frame
Baseline visit-Day 42 End of Participation
Secondary Outcome Measure Information:
Title
Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29
Description
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
Time Frame
Baseline to Day 29 (End of Treatment) Visit
Title
Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm.
Description
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.
Time Frame
Baseline-Day 29 Participation
Title
Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms
Description
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.
Time Frame
Baseline through day 29 (End of Treatment)
Title
The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms.
Description
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)]
Time Frame
Baseline-Day 29 End of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
TCR Medical Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Saint Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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

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