HyperhidrosisPhase 2NCT03024255

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

A Phase 2 study testing BBI-4000 gel, 5%, BBI-4000 gel, 10% and BBI-4000 gel, 15% in people with Hyperhidrosis, run by Botanix Pharmaceuticals.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperhidrosis
What is being tested?: BBI-4000 gel, 5%, BBI-4000 gel, 10% and BBI-4000 gel, 15%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 227 participants
Where: No sites listed yet
Study dates: 22 Dec 2016to 19 Sep 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.).

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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.

About this study

Official title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 Concentrations of Topically Applied BBI-4000 (Sofpironium Bromide) Gel in Subjects With Axillary Hyperhidrosis

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.

Conditions: Hyperhidrosis
Being tested: BBI-4000 gel, 5%, BBI-4000 gel, 10%, BBI-4000 gel, 15%, Vehicle (Placebo)
Keywords: sweat gland disease, sweating, underarm
Medical subject headings: Hyperhidrosis, Sweat Gland Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BBI-4000 gel, 5%Drug
Also called BBI-4000 Low Concentration
BBI-4000 gel, 5% applied once to each axilla daily
BBI-4000 gel, 10%Drug
Also called BBI-4000 Medium Concentration
BBI-4000 gel, 10% applied once to each axilla daily
BBI-4000 gel, 15%Drug
Also called BBI-4000 High Concentration
BBI-4000 gel, 15% applied once to each axilla daily
Vehicle (Placebo)Drug
Also called Control
Placebo, applied once to each axilla daily

Study groups in NCT03024255
Study group	Role	What they receive
BBI-4000 gel, 5%	Experimental	BBI-4000 gel, 5% applied once to each axilla daily Receives: Drug: BBI-4000 gel, 5%
BBI-4000 gel, 10%	Experimental	BBI-4000 gel, 10% applied once to each axilla daily Receives: Drug: BBI-4000 gel, 10%
BBI-4000 gel, 15%	Experimental	BBI-4000 gel, 15% applied once to each axilla daily Receives: Drug: BBI-4000 gel, 15%
Vehicle	Placebo comparator	Placebo, applied once to each axilla daily Receives: Drug: Vehicle (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 201619 Sep 2017

First posted18 Jan 2017 (estimated)
Study start22 Dec 2016
Primary completion19 Sep 2017
Study completion19 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperhidrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03024255
Sponsor's protocol ID: BBI-4000-CL-203
Status last verified: Apr 2023
First submitted: 6 Jan 2017
Last updated: 16 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 Concentrations of Topically Applied BBI-4000 (Sofpironium Bromide) Gel in Subjects With Axillary Hyperhidrosis
ClinicalTrials.gov ID: NCT03024255
Acronym / sponsor ID: BBI-4000-CL-203
Conditions: Hyperhidrosis
Keywords: sweat gland disease, sweating, underarm
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 227 participants (actual)
Lead sponsor: Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 22 Dec 2016 (actual)
Primary completion: 19 Sep 2017 (actual)
Study completion: 19 Sep 2017 (actual)
First posted: 18 Jan 2017 (estimated)
Results: Posted 16 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BBI-4000 gel, 5%	Experimental	Drug: BBI-4000 gel, 5%BBI-4000 gel, 5% applied once to each axilla daily
BBI-4000 gel, 10%	Experimental	Drug: BBI-4000 gel, 10%BBI-4000 gel, 10% applied once to each axilla daily
BBI-4000 gel, 15%	Experimental	Drug: BBI-4000 gel, 15%BBI-4000 gel, 15% applied once to each axilla daily
Vehicle	Placebo comparator	Drug: Vehicle (Placebo)Placebo, applied once to each axilla daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BBI-4000 gel, 5%Also: BBI-4000 Low ConcentrationBBI-4000 gel, 5% applied once to each axilla daily	Drug	BBI-4000 gel, 5%
BBI-4000 gel, 10%Also: BBI-4000 Medium ConcentrationBBI-4000 gel, 10% applied once to each axilla daily	Drug	BBI-4000 gel, 10%
BBI-4000 gel, 15%Also: BBI-4000 High ConcentrationBBI-4000 gel, 15% applied once to each axilla daily	Drug	BBI-4000 gel, 15%
Vehicle (Placebo)Also: ControlPlacebo, applied once to each axilla daily	Drug	Vehicle

Primary outcome

Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy
Time frame: overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.
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
Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity
Time frame: Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)
Subjects reporting more than one adverse event are counted only once using the highest severity.

1 secondary outcome

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

Results and safety

Results posted to the registry on 16 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BBI-4000 Gel, 5%	57	50
BBI-4000 Gel, 10%	57	49
BBI-4000 Gel, 15%	56	45
Vehicle	57	52

Primary outcome: Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy

Time frame: overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.. Least squares mean (Standard Deviation). Unit: score on a scale

Measure	Vehicle n = 53	BBI-4000 Gel, 5% n = 52	BBI-4000 Gel, 10% n = 50	BBI-4000 Gel, 15% n = 47
Value	-1.30 (0.136)	-2.02 (0.135)	-2.09 (0.137)	-2.10 (0.143)

Population analysed: mITT Population

Primary outcome: Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity

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

Measure	Vehicle n = 9	BBI-4000 Gel, 5% n = 17	BBI-4000 Gel, 10% n = 19	BBI-4000 Gel, 15% n = 28
Mild	7	7	10	11
Moderate	2	8	7	13
Severe	0	2	2	4

Population analysed: Number (%) of Subjects Reporting at Least One: TEAE n(%), Safety Population: Vehicle (N=57), BBI-4000 5% (N=57), BBI-4000 10% (N=57), BBI-4000 15% (N=54)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle	0 of 57 (0%)	9 of 57 (15.8%)	0 of 57
BBI-4000 Sofpironium Bromide Gel 5%	1 of 57 (1.8%)	17 of 57 (29.8%)	0 of 57
BBI-4000 Sofpironium Bromide Gel 10%	0 of 57 (0%)	19 of 57 (33.3%)	0 of 57
BBI-4000 Sofpironium Bromide Gel 15%	0 of 54 (0%)	28 of 54 (51.9%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia Walker, MD PhD study director

Botanix Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BBI-4000 gel, 5%, BBI-4000 gel, 10% and BBI-4000 gel, 15% in people with Hyperhidrosis, run by Botanix Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy (time frame: overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03024255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.