Axillary HyperhidrosisPhase 3CardiganINCT03836287
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
A Phase 3 study testing Sofpironium Bromide Gel, 15% in people with Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 39 sites in United States.
Trial summary
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- Sofpironium Bromide Gel, 15%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 39 sitesUnited States
- Study dates
- 9 Oct 2020to 25 Jun 2021
- Phase
- Phase 3
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subject ≥ 9 years of age.
- Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhidrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4 and (c) a minimum GSP of 50 mg in 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(e).
- 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 any cholinergic drug (e.g. bethanechol) within 28 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
DermResearch, Inc.
Austin, Texas, 78759
Center for Clinical & Cosmetic Research
Aventura, Florida, 33180
Haber Dermatology and Cosmetic Surgery, Inc.
Beachwood, Ohio, 44122
Hassman Research Institute
Berlin, New Jersey, 08009
Total Skin and Beauty Dermatology Center, P.C.
Birmingham, Alabama, 35205
Skin Care Research, LLC
Boca Raton, Florida, 33486
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29414
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Skin Research Institute
Coral Gables, Florida, 33146
California Dermatology & Clinical Research Institute
Encinitas, California, 92007
Finlay Medical Research
Greenacres City, Florida, 33467
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111
Aby's New Generation Research
Hialeah, Florida, 33016
Maryland Laser Skin and Vein
Hunt Valley, Maryland, 21030
Dawes Fretzin Research Group
Indianapolis, Indiana, 46250
Dermatology Research Associates
Los Angeles, California, 90045
Baumann Cosmetic and Research Institute
Miami, Florida, 33137
International Dermatology Research, Inc.
Miami, Florida, 33144
My Community Research Center, Inc.
Miami, Florida, 33155
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162
Skin Specialists, P.C.
Omaha, Nebraska, 68144
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Oregon Dermatology & Research Center
Portland, Oregon, 97210
PMG Research of Cary
Raleigh, North Carolina, 27518
Lawrence J Green, MD LLC
Rockville, Maryland, 20850
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Therapeutics Clinical Research
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Investigate MD, LLC
Scottsdale, Arizona, 85255
Dermatology Associates of Seattle
Seattle, Washington, 98101
DermResearch Center of New York, Inc.
Stony Brook, New York, 11790
Grekin Skin Institute
Warren, Michigan, 48088
Research Institute of the Southeast
West Palm Beach, Florida, 33401
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands.
Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.
This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 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 topically applied sofpironium bromide, 15% gel 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.
A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle.
Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points.
The study will be comprised of a total of 13 scheduled visits to take place over approximately 11 to 15 weeks.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- Sofpironium Bromide Gel, 15%, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofpironium Bromide Gel, 15%Drug
Also called BBI-4000 Gel, 15%
Active
VehicleDrug
Also called BBI-4000 Gel, 0%
Vehicle gel
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Sofpironium bromide, 15% gel, once per day Receives: Drug: Sofpironium Bromide Gel, 15% |
| Vehicle | Placebo comparator | Vehicle gel, once per day Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 [better] - 4 [worse]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment [6 weeks] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
Measured: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment
Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right+left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed.
Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4.
End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12.
The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment [6 weeks] minus ranked GSP at baseline) was used as the outcome value.
Measured: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start9 Oct 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
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 Axillary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Walker, MD PhD, Study director, Botanix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836287
- Sponsor's protocol ID
- BBI-4000-CL-301
- Acronym
- CardiganI
- Status last verified
- May 2024
- First submitted
- 6 Feb 2019
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. 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 Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT03836287
- Acronym / sponsor ID
- CardiganI / BBI-4000-CL-301
- Conditions
- Axillary Hyperhidrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands.
Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.
This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
Detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel 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.
A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle.
Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points.
The study will be comprised of a total of 13 scheduled visits to take place over approximately 11 to 15 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Sofpironium Bromide Gel, 15%Sofpironium bromide, 15% gel, once per day |
| Vehicle | Placebo comparator | Drug: VehicleVehicle gel, once per day |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject ≥ 9 years of age.
- Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhidrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4 and (c) a minimum GSP of 50 mg in 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 (8 listed)
- In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(e).
- 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 any cholinergic drug (e.g. bethanechol) within 28 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.).
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 |
|---|---|---|
| Sofpironium Bromide Gel, 15%Also: BBI-4000 Gel, 15%Active | Drug | Active |
| VehicleAlso: BBI-4000 Gel, 0%Vehicle gel | Drug | Vehicle |
Primary outcome
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment
Time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 [better] - 4 [worse]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment [6 weeks] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment
Time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right+left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed. Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4. End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12. The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment [6 weeks] minus ranked GSP at baseline) was used as the outcome value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofpironium Bromide Gel, 15% in people with Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 39 sites in United States.
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 8 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Jun 2024). 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?
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment (time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.). 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?
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 6 Jun 2024.