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A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BBI-4000 Gel, 5%
BBI-4000 Gel, 10%
BBI-4000 Gel, 15%
Vehicle
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary axillary hyperhidrosis of at least 6 months's duration
  • Hyperhidrosis disease severity score of 3 or 4 at baseline
  • Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature)
  • Willing to refrain from using any other antiperspirant agent for the duration of the study.
  • 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 in the axilla or near the axillary area, other than hyperhidrosis.

  • Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including:

    1. Botulinum toxin to the axillary area within 1 year of the baseline visit.
    2. Axillary iontophoresis within 12 weeks of baseline visit.
    3. Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past.
  • Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit.
  • Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause.
  • Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, 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.
  • Prior treatment with the study drug in a previous trial.
  • Any major illness within 30 days before the screening examination.
  • Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.

Sites / Locations

  • Center for Dermatology Clinical Research, Inc.
  • Therapeutics Clinical Research
  • Center for Clinical and Cosmetic Research
  • International Dermatology Research, Inc.
  • International Clinical Research
  • Shideler Clinical Research Center
  • The Indiana Clinical Trials Center
  • Minnesota Clinical Study Center
  • Saint Louis University Dermatology
  • Academic Dermatology Associates
  • The Center for Skin Research
  • Virginia Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BBI-4000 Gel, 5%

BBI-4000 Gel, 10%

BBI-4000 Gel, 15%

Vehicle

Arm Description

Low concentration of BBI-4000; BBI-4000 Gel, 5%

Middle concentration of BBI-4000; BBI-4000 Gel, 10%

High concentration of BBI-4000; BBI-4000 Gel, 15%

Vehicle (placebo); BBI-4000 Gel, 0%

Outcomes

Primary Outcome Measures

Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities

Secondary Outcome Measures

Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)
Sweat production unit of measure was weight-based (mg); absolute change was calculated by adding the left and right axillae sweat weights and calculating absolute change by subtracting day 29 from baseline sweat weights
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4
Randomized participants that provided samples for gravimetric sweat measures, baseline and day 29; Percent Change was calculated by dividing absolute change by baseline gravimetric measurement x 100%

Full Information

First Posted
January 8, 2015
Last Updated
February 16, 2023
Sponsor
Botanix Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02336503
Brief Title
A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Official Title
A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2015 (Actual)
Primary Completion Date
November 5, 2015 (Actual)
Study Completion Date
November 5, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.
Detailed Description
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis. Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period. Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs. Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production. PK blood samples will be taken from study subjects from selected centers.

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
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBI-4000 Gel, 5%
Arm Type
Experimental
Arm Description
Low concentration of BBI-4000; BBI-4000 Gel, 5%
Arm Title
BBI-4000 Gel, 10%
Arm Type
Experimental
Arm Description
Middle concentration of BBI-4000; BBI-4000 Gel, 10%
Arm Title
BBI-4000 Gel, 15%
Arm Type
Experimental
Arm Description
High concentration of BBI-4000; BBI-4000 Gel, 15%
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle (placebo); BBI-4000 Gel, 0%
Intervention Type
Drug
Intervention Name(s)
BBI-4000 Gel, 5%
Other Intervention Name(s)
BBI-4000 Low Dose
Intervention Description
BBI-4000 Gel, 5%
Intervention Type
Drug
Intervention Name(s)
BBI-4000 Gel, 10%
Other Intervention Name(s)
BBI-4000 Middle Dose
Intervention Description
BBI-4000 Gel, 10%
Intervention Type
Drug
Intervention Name(s)
BBI-4000 Gel, 15%
Other Intervention Name(s)
BBI-4000 High Dose
Intervention Description
BBI-4000 Gel, 15%
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
Placebo, BBI-4000 Gel, 0%
Primary Outcome Measure Information:
Title
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Description
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Time Frame
Baseline through Week 4 (Day 29)
Secondary Outcome Measure Information:
Title
Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Description
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Time Frame
Baseline through Week 4 (Day 29)
Title
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)
Description
Sweat production unit of measure was weight-based (mg); absolute change was calculated by adding the left and right axillae sweat weights and calculating absolute change by subtracting day 29 from baseline sweat weights
Time Frame
Baseline through Week 4 (Day 29)
Title
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4
Description
Randomized participants that provided samples for gravimetric sweat measures, baseline and day 29; Percent Change was calculated by dividing absolute change by baseline gravimetric measurement x 100%
Time Frame
Baseline through Week 4 (Day 29)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary axillary hyperhidrosis of at least 6 months's duration Hyperhidrosis disease severity score of 3 or 4 at baseline Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature) Willing to refrain from using any other antiperspirant agent for the duration of the study. 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 in the axilla or near the axillary area, other than hyperhidrosis. Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including: Botulinum toxin to the axillary area within 1 year of the baseline visit. Axillary iontophoresis within 12 weeks of baseline visit. Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past. Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit. Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause. Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, 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. Prior treatment with the study drug in a previous trial. Any major illness within 30 days before the screening examination. Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Walker, MD PhD
Organizational Affiliation
Botanix Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
International Clinical Research
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Saint Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
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

Learn more about this trial

A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

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