Trial · NCT03948646

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)

NCT03948646, Phase 3, Completed, Botanix Pharmaceuticals; results first posted 2024-05-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302). Trials, record NCT03948646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03948646

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
NCT number: NCT03948646
Status: Completed
Phases: Phase 3
Enrollment: 351 participants, actual
Lead sponsor: Botanix Pharmaceuticals
Conditions: Axillary Hyperhidrosis
Interventions: Sofpironium Bromide, 15%, Vehicle
First posted: 2019-05-14
Last updated: 2024-05-21
Results first posted: 2024-05-21

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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).
Primary	Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	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.	Intent-to-treat	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment	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.	Intent-to-Treat	milligrams	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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	Active	Number of Participants YES Observed ≥2-point improvement	108		Participants
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	Vehicle	Number of Participants YES Observed ≥2-point improvement	75		Participants
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	Active	Number of Participants NO Observed ≥2-point improvement	54		Participants
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	Vehicle	Number of Participants NO Observed ≥2-point improvement	84		Participants
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment	Active		-29.85	Standard Deviation 93.190	milligrams
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment	Vehicle		-7.22	Standard Deviation 93.255	milligrams

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active	180
Overall Study	STARTED	Vehicle	171
Overall Study	COMPLETED	Active	160
Overall Study	COMPLETED	Vehicle	155
Overall Study	NOT COMPLETED	Active	20
Overall Study	NOT COMPLETED	Vehicle	16

Source ClinicalTrials.gov

Adverse events28

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
other	Application Site Pain	General disorders	Active	18	180
other	Application Site Pain	General disorders	Vehicle	2	171
other	Application Site Erythema	General disorders	Active	14	180
other	Application Site Erythema	General disorders	Vehicle	0	171
other	Application Site Dermatitis	General disorders	Active	10	180
other	Application Site Dermatitis	General disorders	Vehicle	0	171
other	Application Site Irritation	General disorders	Active	6	180
other	Application Site Irritation	General disorders	Vehicle	1	171
other	Application Site Pruritis	General disorders	Active	4	180
other	Application Site Pruritis	General disorders	Vehicle	1	171

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active	0	180
Total, all-cause mortality	Vehicle	0	171
Total, other adverse events	Active	80	180
Total, other adverse events	Vehicle	9	171
Total, serious adverse events	Active	1	180
Total, serious adverse events	Vehicle	0	171

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
Active vs Vehicle: deaths from any cause	Trial comparisons
Active vs Vehicle: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03948646

GET https://conductscience.org/api/trials/v1/NCT03948646/events?page=2

API reference For AI assistants