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CompletedNCT03024255Updated May 16, 2023Results posted

A Confirmatory 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. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.

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

Phase
Phase 2
Study type
Interventional
Enrollment
227
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied 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.

Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.

02

Conditions studied

  • Hyperhidrosis

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Keywords

  • sweat gland disease
  • sweating
  • underarm
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female subject ≥ 18 years of age.
  • Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c) HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg.
  • The ability to understand and follow all study-related procedures including study drug administration.
  • Sexually active female of childbearing potential (FOCBP)* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product.

Exclusion criteria

Exclusion Criteria:

  • In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s).
  • Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis.
  • Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration.
  • Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6.
  • Use of any cholinergic drug (e.g. bethanechol) within 30 days.
  • Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.).
  • Subjects with unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions, Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion.
  • Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
  • Subject is pregnant, lactating or is planning to become pregnant during the study.
  • History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.
04

Study design

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

Study arms

  • Experimental
    BBI-4000 gel, 5%

    BBI-4000 gel, 5% applied once to each axilla daily

    Drug: BBI-4000 gel, 5%

  • Experimental
    BBI-4000 gel, 10%

    BBI-4000 gel, 10% applied once to each axilla daily

    Drug: BBI-4000 gel, 10%

  • Experimental
    BBI-4000 gel, 15%

    BBI-4000 gel, 15% applied once to each axilla daily

    Drug: BBI-4000 gel, 15%

  • Placebo comparator
    Vehicle

    Placebo, applied once to each axilla daily

    Drug: Vehicle (Placebo)

Interventions

  • DrugBBI-4000 gel, 5%

    BBI-4000 gel, 5% applied once to each axilla daily

    Also known as: BBI-4000 Low Concentration

  • DrugBBI-4000 gel, 10%

    BBI-4000 gel, 10% applied once to each axilla daily

    Also known as: BBI-4000 Medium Concentration

  • DrugBBI-4000 gel, 15%

    BBI-4000 gel, 15% applied once to each axilla daily

    Also known as: BBI-4000 High Concentration

  • DrugVehicle (Placebo)

    Placebo, applied once to each axilla daily

    Also known as: Control

05

What researchers measure

Primary outcomes

  1. Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy

    11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4). The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax

    Time frame: overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.

  2. Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity

    Subjects reporting more than one adverse event are counted only once using the highest severity.

    Time frame: Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)

Secondary outcomes

  1. Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population

    Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed. Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.

    Time frame: Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57

06

Results

Posted May 16, 2023

Participant flow

Participant flow — Overall Study
MilestoneBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Vehicle
Started57575657
Completed50494552
Not completed78115
Withdrew: Adverse event1480
Withdrew: Withdrawal by subject3103
Withdrew: Protocol violation0020
Withdrew: Lost to follow-up1211
Withdrew: Lack of efficacy1000
Withdrew: Protocol noncompliance1101

Outcome measures

PrimaryChange of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy

11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4). The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax

Time frame:
overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.
Reported as:
Least squares mean · score on a scale
Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy
score on a scaleVehicleBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%
Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy-1.30 ± 0.136-2.02 ± 0.135-2.09 ± 0.137-2.10 ± 0.143
PrimaryNumber (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity

Subjects reporting more than one adverse event are counted only once using the highest severity.

Time frame:
Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)
Reported as:
Count of participants · Participants
Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity
ParticipantsVehicleBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%
Mild771011
Moderate28713
Severe0224
SecondaryAverage Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population

Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed. Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.

Time frame:
Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57
Reported as:
Mean · Combined Axilla GSP (mg)
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population
Combined Axilla GSP (mg)VehicleBBI-4000 Gel 5%BBI-4000 Gel 10%BBI-4000 Gel 15%
Baseline259.53 ± 141.738282.41 ± 201.920281.63 ± 211.542316.39 ± 201.478
Day 8137.36 ± 144.104124.94 ± 199.072113.77 ± 119.233118.49 ± 129.393
Day 15131.50 ± 100.171114.24 ± 175.195114.07 ± 169.784106.68 ± 121.225
Day 22141.10 ± 153.886102.43 ± 213.006112.34 ± 128.03390.48 ± 98.380
Day 29114.12 ± 91.999106.06 ± 180.981168.13 ± 230.825117.60 ± 135.284
Day 36142.87 ± 156.561105.16 ± 200.641124.33 ± 147.519126.44 ± 231.723
Day 41116.61 ± 132.620119.00 ± 195.636117.85 ± 141.07093.21 ± 131.063
Day 42110.96 ± 161.59095.09 ± 157.573111.98 ± 140.92788.62 ± 103.408
Day 43159.13 ± 157.113139.65 ± 291.857105.03 ± 108.026117.34 ± 159.217
Day 57163.43 ± 193.565112.09 ± 181.185177.62 ± 242.634135.76 ± 165.620

Adverse events

Collected over Treatment-Emergent Adverse Events (TEAEs) were collected from during investigational treatment Days 1 to 42. A safety follow-up assessment including of TEAEs was also performed ~14 days post end of treatment. A total of 225 subjects were included in the Safety population (54 subjects in the 15% group; and 57 subjects each in the 10%, 5%, and vehicle groups).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vehicle0/57 (0%)0/57 (0%)9/57 (15.8%)
BBI-4000 Sofpironium Bromide Gel 5%0/57 (0%)1/57 (1.8%)17/57 (29.8%)
BBI-4000 Sofpironium Bromide Gel 10%0/57 (0%)0/57 (0%)19/57 (33.3%)
BBI-4000 Sofpironium Bromide Gel 15%0/54 (0%)0/54 (0%)28/54 (51.9%)
Most frequent serious events
Most frequent serious events
EventVehicleBBI-4000 Sofpironium Bromide Gel 5%BBI-4000 Sofpironium Bromide Gel 10%BBI-4000 Sofpironium Bromide Gel 15%
Staphylococcal osteomyelitis / T8-T9 osteomyelitis/discitis with biopsy positive for streptococcus aInfections and infestations0/571/570/570/54
Most frequent other events
Showing 10 of 58
Most frequent other events
EventVehicleBBI-4000 Sofpironium Bromide Gel 5%BBI-4000 Sofpironium Bromide Gel 10%BBI-4000 Sofpironium Bromide Gel 15%
Dry MouthGastrointestinal disorders1/579/5710/5712/54
Vision BlurredEye disorders0/572/576/575/54
Application Site PainGeneral disorders0/571/573/575/54
Urinary hesitationRenal and urinary disorders0/570/572/574/54
Application Site PruritusGeneral disorders0/570/573/573/54
NasopharyngitisInfections and infestations0/573/571/573/54
Application site dermatitisGeneral disorders0/573/571/570/54
Application site erythemaGeneral disorders0/571/571/572/54
Application site rashGeneral disorders0/571/570/572/54
Application site folliculitisGeneral disorders0/570/570/572/54

Baseline characteristics

Safety Population includes all subjects randomized in the study who received study drug at least once. Treatment group assignment was based on the treatment actually received. Two participants were randomized to BBI-4000 gel, 15% but were not dispensed the medication.

Age, Continuous
Age, Continuous(years)VehicleBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Total
Mean30.0 ± 8.6230.8 ± 10.2233.7 ± 11.2930.7 ± 9.2431.3 ± 9.94
Sex: Female, Male
Sex: Female, Male(Participants)VehicleBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Total
Female30252225102
Male27323529123
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VehicleBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Total
Hispanic or Latino138121548
Not Hispanic or Latino44494539177
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VehicleBBI-4000 Gel, 5%BBI-4000 Gel, 10%BBI-4000 Gel, 15%Total
American Indian or Alaska Native10001
Asian13329
Native Hawaiian or Other Pacific Islander00000
Black or African American10491033
White41474442174
More than one race32106
Unknown or Not Reported11002
07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Study protocol · Feb 22, 2017
  • Statistical analysis plan · Jul 27, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03024255
Lead sponsor
Botanix Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 18, 2017
Start date
Dec 22, 2016
Primary completion
Sep 19, 2017
Completion
Sep 19, 2017
Results posted
May 16, 2023
Last update
May 16, 2023

Study contacts

Patricia Walker, MD PhD
study director · Botanix Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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