9 and older, any sex, with Axillary Hyperhidrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 TreatmentPrimary· 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 compa
Number of Participants YES Observed ≥2-point improvement
Group
Value
95% CI
Active
108
Vehicle
75
Number of Participants NO Observed ≥2-point improvement
Group
Value
95% CI
Active
54
Vehicle
84
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of TreatmentPrimary· 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.
Group
Value
95% CI
Active
-29.85
± 93.190
Vehicle
-7.22
± 93.255
Adverse events — posted to ClinicalTrials.gov
Time frame: 11-15 weeks.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Botanix Pharmaceuticals
Last refreshed: 21 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03948646.