Trial Outcomes & Findings for Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (NCT NCT03948646)

Last Updated: 2024-05-21

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

351 participants

Primary outcome timeframe

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.

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Active Sofpironium bromide, 15% gel, once per day Sofpironium Bromide, 15%: Active	Vehicle Vehicle gel, once per day Vehicle: Vehicle gel
Overall Study STARTED	180	171
Overall Study COMPLETED	160	155
Overall Study NOT COMPLETED	20	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=180 Participants Sofpironium bromide, 15% gel, once per day Sofpironium Bromide, 15%: Active	Vehicle n=171 Participants Vehicle gel, once per day Vehicle: Vehicle gel	Total n=351 Participants Total of all reporting groups
Age, Continuous	32.1 years STANDARD_DEVIATION 12.22 • n=5 Participants	31.7 years STANDARD_DEVIATION 11.13 • n=7 Participants	31.9 years STANDARD_DEVIATION 11.67 • n=5 Participants
Age, Customized 9-12 Years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Customized 13-16 Years	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Age, Customized 17-30 Years	77 Participants n=5 Participants	83 Participants n=7 Participants	160 Participants n=5 Participants
Age, Customized ≥31 Years	90 Participants n=5 Participants	81 Participants n=7 Participants	171 Participants n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	103 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	68 Participants n=7 Participants	156 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	48 Participants n=5 Participants	45 Participants n=7 Participants	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	124 Participants n=7 Participants	256 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) White	141 Participants n=5 Participants	133 Participants n=7 Participants	274 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Time since start of Axillary Hyperhidrosis symptoms	202.58 Months STANDARD_DEVIATION 131.948 • n=5 Participants	194.36 Months STANDARD_DEVIATION 117.303 • n=7 Participants	198.47 Months STANDARD_DEVIATION 124.672 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	Active n=162 Participants Sofpironium bromide, 15% gel, once per day Sofpironium Bromide, 15%: Active	Vehicle n=159 Participants Vehicle gel, once per day Vehicle: Vehicle gel
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 Number of Participants YES Observed ≥2-point improvement	108 Participants	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 Number of Participants NO Observed ≥2-point improvement	54 Participants	84 Participants

PRIMARY outcome

Timeframe: 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.

Population: Intent-to-Treat

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.

Outcome measures

Outcome measures
Measure	Active n=160 Participants Sofpironium bromide, 15% gel, once per day Sofpironium Bromide, 15%: Active	Vehicle n=157 Participants Vehicle gel, once per day Vehicle: Vehicle gel
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment	-29.85 milligrams Standard Deviation 93.190	-7.22 milligrams Standard Deviation 93.255

Adverse Events

Active

Serious events: 1 serious events

Other events: 80 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=180 participants at risk Sofpironium bromide, 15% gel, once per day Sofpironium Bromide, 15%: Active	Vehicle n=171 participants at risk Vehicle gel, once per day Vehicle: Vehicle gel
Infections and infestations Appendicitis	0.56% 1/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks

Other adverse events

Other adverse events
Measure	Active n=180 participants at risk Sofpironium bromide, 15% gel, once per day Sofpironium Bromide, 15%: Active	Vehicle n=171 participants at risk Vehicle gel, once per day Vehicle: Vehicle gel
General disorders Application Site Pain	10.0% 18/180 • 11-15 weeks	1.2% 2/171 • 11-15 weeks
General disorders Application Site Erythema	7.8% 14/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks
General disorders Application Site Dermatitis	5.6% 10/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks
General disorders Application Site Irritation	3.3% 6/180 • 11-15 weeks	0.58% 1/171 • 11-15 weeks
General disorders Application Site Pruritis	2.2% 4/180 • 11-15 weeks	0.58% 1/171 • 11-15 weeks
Gastrointestinal disorders Dry Mouth	17.2% 31/180 • 11-15 weeks	1.2% 2/171 • 11-15 weeks
Gastrointestinal disorders Constipation	2.2% 4/180 • 11-15 weeks	1.2% 2/171 • 11-15 weeks
Eye disorders Vision Blurred	11.7% 21/180 • 11-15 weeks	0.58% 1/171 • 11-15 weeks
Eye disorders Mydriasis	5.0% 9/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks
Eye disorders Dry Eye	3.3% 6/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks
Renal and urinary disorders Urinary Retention	3.3% 6/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks
Renal and urinary disorders Urinary Hesitation	2.2% 4/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks
Nervous system disorders Headache	2.2% 4/180 • 11-15 weeks	0.00% 0/171 • 11-15 weeks

Additional Information

Anthony Robinson MS CRNP

Botanix Pharmaceuticals

Phone: +1 (445) 300-3403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Agreement terms prioritized a multi-center publication at the study end. Should such a publication not be completed, an investigator right to individually publish results of his/her study (limited to his/her site data) was included, if for purely scientific or educational purposes; not for any commercial purposes. PI(s) were to submit draft materials to the Sponsor 60 days prior to Investigator release of individual abstract or manuscript. Additional disclosure restrictions and terms applied.
Publication restrictions are in place

Restriction type: OTHER