Trial · NCT03627468
A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
NCT03627468, Phase 3, Completed, Botanix Pharmaceuticals; results first posted 2023-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis. Trials, record NCT03627468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03627468
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
- NCT number
- NCT03627468
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Botanix Pharmaceuticals
- Conditions
- Primary Axillary Hyperhidrosis
- Interventions
- Sofpironium Bromide Gel, 5%, Sofpironium Bromide Gel, 15%
- First posted
- 2018-08-13
- Last updated
- 2023-05-19
- Results first posted
- 2023-05-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | All safety subjects, reaching week 48 or not | 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 |
| Primary | Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) | All Safety Subject, Baseline-Through study completion (48 weeks) or Not | 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. |
| Secondary | The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score | From baseline to each visit through study completion (48 weeks) | 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. |
| Secondary | 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 | From baseline to each visit through study completion (48 weeks) | 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. |
| Secondary | The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score | From baseline to each visit through study completion (48 weeks) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | All safety subjects, reaching week 48 or not | Overall number of participants analyzed included the Safety Population. Subunits: Subjects reporting any TEAE made up the overall number of units analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) | All Safety Subject, Baseline-Through study completion (48 weeks) or Not | Safety population, units analyzed: subject incidence of report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rating either as Absent or Minimal, Mild, Moderate or Severe. Subjects where local tolerability assessment was not completed were also included. | participants | NUMBER |
| SECONDARY | The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score | From baseline to each visit through study completion (48 weeks) | ITT population and subjects with Baseline-End of Treatment HDSM-Ax-11© scores | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | From baseline to each visit through study completion (48 weeks) | ITT population and subjects with Baseline-End of Treatment HDSM-Ax-11© scores | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score | From baseline to each visit through study completion (48 weeks) | ITT population and subjects with Baseline-End of Treatment HDSM-Ax-11© scores | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 5% | Mild Severity | 27 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 15% | Mild Severity | 55 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 5% | Moderate Severity | 29 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 15% | Moderate Severity | 58 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 5% | Severe Severity | 2 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 15% | Severe Severity | 17 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 5% | Missing | 0 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 15% | Missing | 0 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 5% | No TEAE Reported | 44 | Participants | |
| The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity | Gel, 15% | No TEAE Reported | 67 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gel, 5% | 103 | |
| Overall Study | STARTED | Gel, 15% | 197 | |
| Overall Study | COMPLETED | Gel, 5% | 72 | |
| Overall Study | COMPLETED | Gel, 15% | 118 | |
| Overall Study | NOT COMPLETED | Gel, 5% | 31 | |
| Overall Study | NOT COMPLETED | Gel, 15% | 79 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site pruritus | General disorders | Gel, 5% | 6 | 102 | |
| other | Application site pruritus | General disorders | Gel, 15% | 29 | 197 | |
| other | Application site pain | General disorders | Gel, 5% | 4 | 102 | |
| other | Application site pain | General disorders | Gel, 15% | 29 | 197 | |
| other | Application site dermatitis | General disorders | Gel, 5% | 6 | 102 | |
| other | Application site dermatitis | General disorders | Gel, 15% | 21 | 197 | |
| other | Application site erythema | General disorders | Gel, 5% | 6 | 102 | |
| other | Application site erythema | General disorders | Gel, 15% | 15 | 197 | |
| other | Application site irritation | General disorders | Gel, 5% | 5 | 102 | |
| other | Application site irritation | General disorders | Gel, 15% | 11 | 197 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gel, 5% | 1 | 102 |
| Total, all-cause mortality | Gel, 15% | 0 | 197 |
| Total, other adverse events | Gel, 5% | 58 | 102 |
| Total, other adverse events | Gel, 15% | 131 | 197 |
| Total, serious adverse events | Gel, 5% | 1 | 102 |
| Total, serious adverse events | Gel, 15% | 4 | 197 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gel, 5% vs Gel, 15%: deaths from any cause | Trial comparisons |
| Gel, 5% vs Gel, 15%: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03627468
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