ClinicalTrials.gg
Sign In
CompletedNCT02336503Updated Mar 15, 2023Results posted

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

A Phase 2 interventional study of BBI-4000 Gel, 5% and BBI-4000 Gel, 10% in Hyperhidrosis, sponsored by Botanix Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Botanix Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperhidrosis

Browse trials for

03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 189 is above the median of 50 across 99 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 65 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

  • 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 must agree to use a medically acceptable method of while participating in the study.

Exclusion criteria

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, , 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 to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
  • Pregnant or lactating women.
  • Use of an 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
189 participants (actual)

Study arms

  • Experimental
    BBI-4000 Gel, 5%

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

    Drug: BBI-4000 Gel, 5%

  • Experimental
    BBI-4000 Gel, 10%

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

    Drug: BBI-4000 Gel, 10%

  • Experimental
    BBI-4000 Gel, 15%

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

    Drug: BBI-4000 Gel, 15%

  • Placebo comparator
    Vehicle

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

    Drug: Vehicle

Interventions

  • DrugBBI-4000 Gel, 5%

    BBI-4000 Gel, 5%

    Also known as: BBI-4000 Low Dose

  • DrugBBI-4000 Gel, 10%

    BBI-4000 Gel, 10%

    Also known as: BBI-4000 Middle Dose

  • DrugBBI-4000 Gel, 15%

    BBI-4000 Gel, 15%

    Also known as: BBI-4000 High Dose

  • DrugVehicle

    Placebo, BBI-4000 Gel, 0%

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline through Week 4 (Day 29)

Secondary outcomes

  1. 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

    Time frame: Baseline through Week 4 (Day 29)

  2. 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

    Time frame: Baseline through Week 4 (Day 29)

  3. 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%

    Time frame: Baseline through Week 4 (Day 29)

07

Results

Posted Mar 15, 2023

Participant flow

Participant flow — Overall Study
MilestoneBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Vehicle
Started47484846
Completed45454740
Not completed2316
Withdrew: Lost to follow-up0302
Withdrew: Withdrawal by subject2004
Withdrew: Adverse event0010

Outcome measures

PrimaryProportion 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

Time frame:
Baseline through Week 4 (Day 29)
Reported as:
Count of participants · Participants
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
ParticipantsBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Vehicle
No35372936
Yes1210185
SecondaryProportion 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

Time frame:
Baseline through Week 4 (Day 29)
Reported as:
Count of participants · Participants
Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
ParticipantsBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Vehicle
No25261323
Yes22213418
SecondaryAbsolute 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

Time frame:
Baseline through Week 4 (Day 29)
Reported as:
Mean · mg
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)
mgBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Vehicle
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)-183.1 ± 370.85-56.4 ± 277.81-171.9 ± 344.54-172.9 ± 315.89
SecondaryPercent 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%

Time frame:
Baseline through Week 4 (Day 29)
Reported as:
Mean · percentage of change
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4
percentage of changeBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Vehicle
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4-31.9 ± 84.95-15.7 ± 115.03-35.7 ± 65.48-41.7 ± 40.73

Adverse events

Collected over Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BBI-4000 Gel, 5%0/47 (0%)0/47 (0%)8/47 (17%)
BBI-4000 Gel, 10%0/48 (0%)0/48 (0%)12/48 (25%)
BBI-4000 Gel, 15%0/48 (0%)0/48 (0%)14/48 (29.2%)
Vehicle0/46 (0%)0/46 (0%)6/46 (13%)
Most frequent other events
Showing 10 of 35
Most frequent other events
EventBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Vehicle
Dry MouthGastrointestinal disorders2/472/484/480/46
Vision BlurredEye disorders2/472/483/480/46
NasopharyngitisInfections and infestations0/471/480/482/46
Upper Respiratory Tract InfectionInfections and infestations0/470/480/482/46
Application Site DermatitisGeneral disorders2/470/481/480/46
Application Site PainGeneral disorders2/472/481/480/46
Application Site PruritusGeneral disorders2/471/480/480/46
Application Site RashGeneral disorders0/472/480/480/46
Tooth AcheGastrointestinal disorders0/470/480/481/46
Bacterial VaginosisInfections and infestations0/470/480/481/46

Baseline characteristics

Population (N=189) was defined as all randomized subjects

Age, Continuous
Age, Continuous(years)BBI-4000 Dose 1BBI-4000 Dose 2BBI-4000 Dose 3VehicleTotal
Mean32.6 ± 10.3433.4 ± 10.6135.5 ± 11.6432.4 ± 8.2333.5 ± 10.30
Sex: Female, Male
Sex: Female, Male(Participants)BBI-4000 Dose 1BBI-4000 Dose 2BBI-4000 Dose 3VehicleTotal
Female24252727103
Male2323211986
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BBI-4000 Dose 1BBI-4000 Dose 2BBI-4000 Dose 3VehicleTotal
Hispanic or Latino1312111349
Not Hispanic or Latino34363733140
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BBI-4000 Dose 1BBI-4000 Dose 2BBI-4000 Dose 3VehicleTotal
American Indian or Alaska Native11013
Asian00314
Native Hawaiian or Other Pacific Islander00000
Black or African American111391144
White35343532136
More than one race00000
Unknown or Not Reported00112
08

Study locations

12 sites
  • Center for Dermatology Clinical Research, Inc.
    Fremont, California 94538, United States
  • Therapeutics Clinical Research
    San Diego, California 92123, United States
  • Center for Clinical and Cosmetic Research
    Aventura, Florida 33180, United States
  • International Dermatology Research, Inc.
    Miami, Florida 33144, United States
  • International Clinical Research
    Sanford, Florida 32771, United States
  • Shideler Clinical Research Center
    Carmel, Indiana 46032, United States
  • The Indiana Clinical Trials Center
    Plainfield, Indiana 46168, United States
  • Minnesota Clinical Study Center
    Fridley, Minnesota 55432, United States
  • Saint Louis University Dermatology
    Saint Louis, Missouri 63122, United States
  • Academic Dermatology Associates
    Albuquerque, New Mexico 87106, United States
  • The Center for Skin Research
    Houston, Texas 77056, United States
  • Virginia Clinical Research, Inc.
    Norfolk, Virginia 23507, United States
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Nov 2015, 7 months.

Results were first posted in Mar 2023, 7 years 4 months after primary completion. A results delay was requested in Jul 2018.

Of 14 phase 2 interventional studies under Hyperhidrosis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 11. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2015
First posted
Jan 13, 2015
StartActual
Mar 10, 2015
Primary completionActual
Nov 5, 2015
CompletionActual
Nov 5, 2015
Results delay requested
Jul 17, 2018
Results first posted
Mar 15, 2023
Last update
Mar 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02336503
Lead sponsor
Botanix Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 13, 2015
Start date
Mar 10, 2015
Primary completion
Nov 5, 2015
Completion
Nov 5, 2015
Results posted
Mar 15, 2023
Last update
Mar 15, 2023

Study contacts

Patricia Walker, MD PhD
study director · Botanix Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Sofpironium

Other studies in this condition

Hyperhidrosis →

Other studies from this sponsor

Botanix Pharmaceuticals

Start the discussion