Primary Axillary HyperhidrosisPhase 2NCT03785587
A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
A Phase 2 study testing Sofpironium Bromide Gel, 15% in people with Primary Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 1 site 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 to 16 years
- Conditions the study is for
- Primary Axillary Hyperhidrosis
- What is being tested?
- Sofpironium Bromide Gel, 15%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2018to 6 Sep 2019
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subject ≥9 to <17 years of age in good general health.
- Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 2 - 4 inclusive at both the Screening Visit (Visit 1) and Baseline Visit (Visit 2). (b) Symptoms of axillary hyperhidrosis for greater than or equal to 6 months' duration prior to enrollment.
Who cannot join
- In the Investigator's opinion, any skin or subcutaneous tissue conditions of the axilla(e), (i.e., the axillary area should be deemed otherwise "normal", besides the hyperhidrosis diagnosis, and free of blisters, large boils or sinus tracts, significant scarring or open wounds).
- Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis: (a) Botulinum toxin to the axillary area within 9 months of enrollment. (b) Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past. (c) Serotonergic agonist (or drugs that increase serotonin activity including SSRIs), beta-blocker, alpha-adrenergic agonist (clonidine), dopamine partial agonist or tricyclic antidepressant treatment within 30 days of enrollment. However, if a subject has been on a stable dose (in the opinion of the PI) of any of these medications and has not had a recent change in hyperhidrosis frequency or severity for 3 months prior to enrollment; they may be included. Doses of these agents should not be altered during the course of the study. (d) Any topical treatment for hyperhidrosis, requiring a prescription, within 3 days of enrollment.
- Anticholinergic agents [with the exception of sofpironium bromide] used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration (e.g., IV, oral, inhaled, topical) within 30 days of the enrollment.
- Use of potent oral inhibitors of cytochrome P450 CYP3A \& CYP2D6 and transporter inhibitors (OCT2/MATE1/MATE2) 14 days prior to enrollment. The use of topical antifungal medications is permitted if not applied in the treatment area.
- Any oral or topical homeopathic or herbal treatment (i.e., alternative therapies such as sage tablets, chamomile, valerian root and St. John's Wort) within 14 days of enrollment.
- Use of any cholinergic drug (e.g., bethanechol) within 30 days of enrollment.
Show all 13Show fewer
- Use of any anti-anxiety and/or anti-depressant, amphetamine product or drugs with known anticholinergic side effects is prohibited with the following exceptions: (a) If a subject has been on a stable dose of an anti-anxiety and/or anti-depressant drug and has not had a recent change in hyperhidrosis frequency or severity for 3 months; they may be included. (b) An amphetamine product may be allowed if the dose has been stable for greater than or equal to 6 months without change in hyperhidrosis frequency or severity for 3 months. (c) Drugs with known anticholinergic side effects (taken within the last 30 days), including dry mouth, blurred vision, may be allowed based on the Principal Investigator's assessment.
- Known causes 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 hyperhidrosis symptoms initiated or exacerbated with menopause.
- Subjects with unstable type 1 or type 2 diabetes mellitus or thyroid disease, history of renal impairment, hepatic impairment, malignancy, 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 in the Investigator's opinion.
- 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.
- Unable or unwilling to undergo multiple venipunctures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
About this study
Official title: A Multi-Center Open-Label Extension Study to Assess the Long-Term Safety Tolerability and Pharmacokinetics of Sofpironium Bromide Gel 15% Applied Topically to Children and Adolescents Age 9-17 Years Previously Enrolled in BBI-4000-CL-105
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. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
Read the detailed description
This is an open-label, phase 2 long-term study designed to evaluate the safety, local tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied topically to the axillae.
Subjects will apply the gel once daily at bedtime, to both axillae.
A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%.
Adverse events, vital signs, and local tolerability assessments will be collected at each visit. 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 pharmacokinetics, 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 8 scheduled visits to take place over a 26 week period.
- Conditions
- Primary Axillary Hyperhidrosis
- Being tested
- Sofpironium Bromide Gel, 15%
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
Sofpironium Bromide Gel, 15%
| Study group | Role | What they receive |
|---|---|---|
| Gel, 15% | Experimental | Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks Receives: Drug: Sofpironium Bromide Gel, 15% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).
Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.
Measured: Through study completion (24 weeks).
The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.
Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population
Measured: Through study completion (24 weeks).
The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)
Trough levels of sofpironium based on sampling schedule.
Measured: Through study completion (24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start21 Dec 2018
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
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 Primary 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT03785587
- Sponsor's protocol ID
- BBI-4000-CL-108
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2018
- Last updated
- 14 Mar 2023
- 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 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Open-Label Extension Study to Assess the Long-Term Safety Tolerability and Pharmacokinetics of Sofpironium Bromide Gel 15% Applied Topically to Children and Adolescents Age 9-17 Years Previously Enrolled in BBI-4000-CL-105
- ClinicalTrials.gov ID
- NCT03785587
- Acronym / sponsor ID
- BBI-4000-CL-108
- Conditions
- Primary Axillary Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Posted 14 Mar 2023
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. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
Detailed description
This is an open-label, phase 2 long-term study designed to evaluate the safety, local tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied topically to the axillae.
Subjects will apply the gel once daily at bedtime, to both axillae.
A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%.
Adverse events, vital signs, and local tolerability assessments will be collected at each visit. 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 pharmacokinetics, 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 8 scheduled visits to take place over a 26 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gel, 15% | Experimental | Drug: Sofpironium Bromide Gel, 15%Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female subject ≥9 to <17 years of age in good general health.
- Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 2 - 4 inclusive at both the Screening Visit (Visit 1) and Baseline Visit (Visit 2). (b) Symptoms of axillary hyperhidrosis for greater than or equal to 6 months' duration prior to enrollment.
Key exclusion criteria (13 listed)
- In the Investigator's opinion, any skin or subcutaneous tissue conditions of the axilla(e), (i.e., the axillary area should be deemed otherwise "normal", besides the hyperhidrosis diagnosis, and free of blisters, large boils or sinus tracts, significant scarring or open wounds).
- Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis: (a) Botulinum toxin to the axillary area within 9 months of enrollment. (b) Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past. (c) Serotonergic agonist (or drugs that increase serotonin activity including SSRIs), beta-blocker, alpha-adrenergic agonist (clonidine), dopamine partial agonist or tricyclic antidepressant treatment within 30 days of enrollment. However, if a subject has been on a stable dose (in the opinion of the PI) of any of these medications and has not had a recent change in hyperhidrosis frequency or severity for 3 months prior to enrollment; they may be included. Doses of these agents should not be altered during the course of the study. (d) Any topical treatment for hyperhidrosis, requiring a prescription, within 3 days of enrollment.
- Anticholinergic agents [with the exception of sofpironium bromide] used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration (e.g., IV, oral, inhaled, topical) within 30 days of the enrollment.
- Use of potent oral inhibitors of cytochrome P450 CYP3A \& CYP2D6 and transporter inhibitors (OCT2/MATE1/MATE2) 14 days prior to enrollment. The use of topical antifungal medications is permitted if not applied in the treatment area.
- Any oral or topical homeopathic or herbal treatment (i.e., alternative therapies such as sage tablets, chamomile, valerian root and St. John's Wort) within 14 days of enrollment.
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-4000Sofpironium Bromide Gel, 15% | Drug | Gel, 15% |
Primary outcome
The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).
Time frame: Through study completion (24 weeks).
Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.
The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.
Time frame: Through study completion (24 weeks).
Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population
The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)
Time frame: Through study completion (24 weeks).
Trough levels of sofpironium based on sampling schedule.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sofpironium Bromide Gel, 15% in people with Primary Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 1 site 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 2 inclusion and 13 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 14 Mar 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?
The Number of Participants With Treatment Emergent Adverse Events (All TEAEs). (time frame: Through study completion (24 weeks).). The study lists 3 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 14 Mar 2023.