Back to resultsA Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BBI-4000
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility Criteria
Inclusion Criteria:
- Male or Female subjects from 18 to 45 years of age in good general health.
- Primary axillary hyperhidrosis of at least 6 months duration.
- Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
- Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
- Use of a medically appropriate contraceptive method.
Exclusion Criteria:
- Prior axillary use of botulinum toxin within 2 years of study entry.
- Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
- Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
- Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
- History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
- Known condition that may cause hyperhidrosis.
- Use of an investigational drug within 30 days prior to entry into this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low Strength BBI-4000 and Vehicle
High Strength BBI-4000 and Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Percent change in the gravimetrically measured sweat production from baseline
Secondary Outcome Measures
Absolute change in the gravimetrically measured sweat production from baseline
Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline.
Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline
Full Information
NCT ID
NCT02058264
First Posted
February 6, 2014
Last Updated
December 14, 2022
Sponsor
Botanix Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02058264
Brief Title
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Official Title
A Randomized, Double Blinded, Vehicle-Controlled Study to Evaluate the Safety and the Effect on Sweat Production of Topically Applied BBI-4000 in Subjects With Hyperhidrosis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Botanix Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.
Detailed Description
This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days.
Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology).
Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS).
Pharmacokinetic information will also be collected.
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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Strength BBI-4000 and Vehicle
Arm Type
Experimental
Arm Title
High Strength BBI-4000 and Vehicle
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BBI-4000
Primary Outcome Measure Information:
Title
Percent change in the gravimetrically measured sweat production from baseline
Time Frame
Week 2
Secondary Outcome Measure Information:
Title
Absolute change in the gravimetrically measured sweat production from baseline
Time Frame
Week 2
Title
Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline.
Time Frame
Week 2
Title
Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline
Time Frame
Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female subjects from 18 to 45 years of age in good general health.
Primary axillary hyperhidrosis of at least 6 months duration.
Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
Use of a medically appropriate contraceptive method.
Exclusion Criteria:
Prior axillary use of botulinum toxin within 2 years of study entry.
Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
Known condition that may cause hyperhidrosis.
Use of an investigational drug within 30 days prior to entry into this study.
12. IPD Sharing Statement
Learn more about this trial
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
We'll reach out to this number within 24 hrs