A Phase 3 interventional study of Sofpironium Bromide Gel, 5% and Sofpironium Bromide Gel, 15% in Primary Axillary Hyperhidrosis, sponsored by Botanix Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 9 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Botanix Pharmaceuticals · Phase 3, Interventional, and Treatment
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 long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.
This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety, local tolerability 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 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations.
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 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 17 scheduled visits to take place over a 52 week period.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 300 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →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.
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.
Exclusion Criteria:
NOTE: If anticholinergic side effect(s) are experienced on these medications prior to starting study medication; document the side effect(s) and severities in the source document and the eCRF. The doses of these agents should not be altered during the course of the study.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks
Drug: Sofpironium Bromide Gel, 5%
Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks
Drug: Sofpironium Bromide Gel, 15%
Sofpironium Bromide Gel, 5%
Also known as: BBI-4000
Sofpironium Bromide Gel, 15%
Also known as: BBI-4000
The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity
The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe
Time frame: All safety subjects, reaching week 48 or not
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety)
Number of participants reporting: local tolerability symptoms and severity (worst) symptom ratings; Incidence by subject report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rated either as Absent or Minimal, Mild, Moderate or Severe.
Time frame: All Safety Subject, Baseline-Through study completion (48 weeks) or Not
The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease in subjects with axillary hyperhidrosis. Two questions measured 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 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11total scores) reflected improvement in HDSM-Ax-11© score and condition.
Time frame: From baseline to each visit through study completion (48 weeks)
The Number (%) of Subjects Achieving (-) ≥ 1.5 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11scores) reflected improvement in HDSM-Ax-11© score and condition.
Time frame: From baseline to each visit through study completion (48 weeks)
The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11scores) reflected improvement in HDSM-Ax-11© score and condition.
Time frame: From baseline to each visit through study completion (48 weeks)
| Milestone | Gel, 5% | Gel, 15% |
|---|---|---|
| Started | 103 | 197 |
| Completed | 72 | 118 |
| Not completed | 31 | 79 |
| Withdrew: Adverse event | 5 | 33 |
| Withdrew: Withdrawal by subject | 13 | 23 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Lost to follow-up | 10 | 16 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Pregnancy | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Poor compliance or noncompliance | 0 | 2 |
The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe
| Participants | Gel, 5% | Gel, 15% |
|---|---|---|
| Mild Severity | 27 | 55 |
| Moderate Severity | 29 | 58 |
| Severe Severity | 2 | 17 |
| Missing | 0 | 0 |
| No TEAE Reported | 44 | 67 |
Number of participants reporting: local tolerability symptoms and severity (worst) symptom ratings; Incidence by subject report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rated either as Absent or Minimal, Mild, Moderate or Severe.
| participants | Gel, 5% | Gel, 15% |
|---|---|---|
| Absent | 31 | 59 |
| Minimal | 34 | 41 |
| Mild | 20 | 37 |
| Moderate | 12 | 38 |
| Severe | 4 | 19 |
| Subject Tolerability Assessment not Performed | 1 | 3 |
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease in subjects with axillary hyperhidrosis. Two questions measured 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 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11total scores) reflected improvement in HDSM-Ax-11© score and condition.
| Participants | Gel, 5% | Gel, 15% |
|---|---|---|
| Observed ≥1- point HDSM-AX-11 decrease: YES | 61 | 95 |
| Observed ≥1- point HDSM-AX-11 decrease: NO | 11 | 18 |
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11scores) reflected improvement in HDSM-Ax-11© score and condition.
| Participants | Gel, 5% | Gel, 15% |
|---|---|---|
| Observed ≥1.5 - point HDSM-AX-11 decrease: YES | 55 | 80 |
| Observed ≥1.5 - point HDSM-AX-11 decrease: NO | 17 | 33 |
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11scores) reflected improvement in HDSM-Ax-11© score and condition.
| Participants | Gel, 5% | Gel, 15% |
|---|---|---|
| Observed ≥2- point HDSM-AX-11 decrease: YES | 51 | 70 |
| Observed ≥2- point HDSM-AX-11 decrease: NO | 21 | 43 |
Collected over Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gel, 5% | 1/102 (1%) | 1/102 (1%) | 58/102 (56.9%) |
| Gel, 15% | 0/197 (0%) | 4/197 (2%) | 131/197 (66.5%) |
| Event | Gel, 5% | Gel, 15% |
|---|---|---|
| PneumoniaInfections and infestations | 1/102 | 0/197 |
| Septic ShockInfections and infestations | 1/102 | 0/197 |
| DepressionPsychiatric disorders | 0/102 | 1/197 |
| Suicide AttemptPsychiatric disorders | 0/102 | 1/197 |
| Cardiac MyxomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/102 | 1/197 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 0/102 | 1/197 |
| Event | Gel, 5% | Gel, 15% |
|---|---|---|
| Vision BlurredEye disorders | 5/102 | 37/197 |
| Dry MouthGastrointestinal disorders | 9/102 | 33/197 |
| Application site pruritusGeneral disorders | 6/102 | 29/197 |
| Application site painGeneral disorders | 4/102 | 29/197 |
| Application site dermatitisGeneral disorders | 6/102 | 21/197 |
| Upper respiratory tract infectionInfections and infestations | 9/102 | 8/197 |
| Application site erythemaGeneral disorders | 6/102 | 15/197 |
| Application site irritationGeneral disorders | 5/102 | 11/197 |
| MydriasisEye disorders | 1/102 | 10/197 |
| NasopharyngitisInfections and infestations | 5/102 | 3/197 |
Population: Intent-to-Treat
| Age, Customized(Participants) | Gel, 5% | Gel, 15% | Total |
|---|---|---|---|
| 9-12 years | 1 | 0 | 1 |
| 13-16 years | 3 | 14 | 17 |
| ≥17 years | 99 | 183 | 282 |
| Sex: Female, Male(Participants) | Gel, 5% | Gel, 15% | Total |
|---|---|---|---|
| Female | 59 | 121 | 180 |
| Male | 44 | 76 | 120 |
| Ethnicity (NIH/OMB)(Participants) | Gel, 5% | Gel, 15% | Total |
|---|---|---|---|
| Hispanic or Latino | 26 | 39 | 65 |
| Not Hispanic or Latino | 76 | 157 | 233 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Gel, 5% | Gel, 15% | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 4 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 28 | 47 | 75 |
| White | 74 | 143 | 217 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| HDSM-Ax-11 Scale Score Summary - Baseline Visit(units on a scale) | Gel, 5% | Gel, 15% | Total |
|---|---|---|---|
| Mean | 3.57 ± 0.308 | 3.56 ± 0.316 | 3.565 ± 0.312 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Jan 2020, 16 months.
Results were first posted in May 2023, 3 years 3 months after primary completion.
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Studies of the drug tested here: Sofpironium
Botanix Pharmaceuticals