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CompletedNCT02058264Updated Dec 16, 2022

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

A Phase 1 interventional study of BBI-4000 in Hyperhidrosis, sponsored by Botanix Pharmaceuticals. Completed. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-12-16.

Sponsored by Botanix Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperhidrosis

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03

In context

Hyperhidrosis

112 studies on the registry are indexed under Hyperhidrosis; 9 are open to participants now.

This study's enrollment of 18 is below the median of 51 across 100 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Botanix Pharmaceuticals is the lead sponsor of 11 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Low Strength BBI-4000 and Vehicle

    Drug: BBI-4000

  • Experimental
    High Strength BBI-4000 and Vehicle

    Drug: BBI-4000

Interventions

06

What researchers measure

Primary outcomes

  1. Percent change in the gravimetrically measured sweat production from baseline

    Time frame: Week 2

Secondary outcomes

  1. Absolute change in the gravimetrically measured sweat production from baseline

    Time frame: Week 2

  2. Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline.

    Time frame: Week 2

  3. Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline

    Time frame: Week 2

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02058264
Lead sponsor
Botanix Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 10, 2014
Start date
Feb 2014
Primary completion
Aug 2014
Completion
Sep 2014
Last update
Dec 16, 2022
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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