Trial Outcomes & Findings for A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (NCT NCT03024255)

Last Updated: 2023-05-16

Results Overview

11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures 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 mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

227 participants

Primary outcome timeframe

overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.

Results posted on

2023-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	BBI-4000 Gel, 5% BBI-4000 gel, 5% applied once to each axilla daily	BBI-4000 Gel, 10% BBI-4000 gel, 10% applied once to each axilla daily	BBI-4000 Gel, 15% BBI-4000 gel, 15% applied once to each axilla daily	Vehicle Vehicle (Placebo), applied once to each axilla daily
Overall Study STARTED	57	57	56	57
Overall Study COMPLETED	50	49	45	52
Overall Study NOT COMPLETED	7	8	11	5

Reasons for withdrawal

Reasons for withdrawal
Measure	BBI-4000 Gel, 5% BBI-4000 gel, 5% applied once to each axilla daily	BBI-4000 Gel, 10% BBI-4000 gel, 10% applied once to each axilla daily	BBI-4000 Gel, 15% BBI-4000 gel, 15% applied once to each axilla daily	Vehicle Vehicle (Placebo), applied once to each axilla daily
Overall Study Adverse Event	1	4	8	0
Overall Study Withdrawal by Subject	3	1	0	3
Overall Study Protocol Violation	0	0	2	0
Overall Study Lost to Follow-up	1	2	1	1
Overall Study Lack of Efficacy	1	0	0	0
Overall Study Protocol Noncompliance	1	1	0	1

Baseline Characteristics

A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle n=57 Participants Vehicle (Placebo), administered to each axilla once daily	BBI-4000 Gel, 5% n=57 Participants BBI-4000 gel, 5% administered to each axilla once daily	BBI-4000 Gel, 10% n=57 Participants BBI-4000 gel, 10% administered to each axilla once daily	BBI-4000 Gel, 15% n=54 Participants BBI-4000 gel, 15% administered to each axilla once daily	Total n=225 Participants Total of all reporting groups
Age, Continuous	30.0 years STANDARD_DEVIATION 8.62 • n=5 Participants	30.8 years STANDARD_DEVIATION 10.22 • n=7 Participants	33.7 years STANDARD_DEVIATION 11.29 • n=5 Participants	30.7 years STANDARD_DEVIATION 9.24 • n=4 Participants	31.3 years STANDARD_DEVIATION 9.94 • n=21 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	25 Participants n=7 Participants	22 Participants n=5 Participants	25 Participants n=4 Participants	102 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	32 Participants n=7 Participants	35 Participants n=5 Participants	29 Participants n=4 Participants	123 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	15 Participants n=4 Participants	48 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	49 Participants n=7 Participants	45 Participants n=5 Participants	39 Participants n=4 Participants	177 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	33 Participants n=21 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	47 Participants n=7 Participants	44 Participants n=5 Participants	42 Participants n=4 Participants	174 Participants n=21 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.

Population: mITT Population

Outcome measures

Outcome measures
Measure	Vehicle n=53 Participants Vehicle (Placebo), applied to each axilla once daily	BBI-4000 Gel, 5% n=52 Participants BBBI-4000 Sofpironium Bromide Gel, 5% applied to each axilla once daily	BBI-4000 Gel, 10% n=50 Participants BBBI-4000 Sofpironium Bromide Gel, 10% applied to each axilla once daily	BBI-4000 Gel, 15% n=47 Participants BBBI-4000 Sofpironium Bromide Gel, 15% applied to each axilla once daily
Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy	-1.30 score on a scale Standard Deviation 0.136	-2.02 score on a scale Standard Deviation 0.135	-2.09 score on a scale Standard Deviation 0.137	-2.10 score on a scale Standard Deviation 0.143

PRIMARY outcome

Timeframe: Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)

Population: Number (%) of Subjects Reporting at Least One: TEAE n(%), Safety Population: Vehicle (N=57), BBI-4000 5% (N=57), BBI-4000 10% (N=57), BBI-4000 15% (N=54)

Subjects reporting more than one adverse event are counted only once using the highest severity.

Outcome measures

Outcome measures
Measure	Vehicle n=9 Participants Vehicle (Placebo), applied to each axilla once daily	BBI-4000 Gel, 5% n=17 Participants BBBI-4000 Sofpironium Bromide Gel, 5% applied to each axilla once daily	BBI-4000 Gel, 10% n=19 Participants BBBI-4000 Sofpironium Bromide Gel, 10% applied to each axilla once daily	BBI-4000 Gel, 15% n=28 Participants BBBI-4000 Sofpironium Bromide Gel, 15% applied to each axilla once daily
Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity Mild	7 Participants	7 Participants	10 Participants	11 Participants
Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity Moderate	2 Participants	8 Participants	7 Participants	13 Participants
Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity Severe	0 Participants	2 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57

Population: Overall number of participants analyzed includes those who were compliant with the protocol. Compliance with the protocol per visit at Visits 2-4 (Days -21 to -7), Baseline Visit (Day 1), and Days 8, 15, 22, 29, 36, 41, 42, 43, and 57, affected the number of participants analyzed at these timepoints.

Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed. Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.

Outcome measures

Outcome measures
Measure	Vehicle n=100 Both axilla combined total Vehicle (Placebo), applied to each axilla once daily	BBI-4000 Gel, 5% n=98 Both axilla combined total BBBI-4000 Sofpironium Bromide Gel, 5% applied to each axilla once daily	BBI-4000 Gel, 10% n=94 Both axilla combined total BBBI-4000 Sofpironium Bromide Gel, 10% applied to each axilla once daily	BBI-4000 Gel, 15% n=88 Both axilla combined total BBBI-4000 Sofpironium Bromide Gel, 15% applied to each axilla once daily
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Baseline	259.53 Combined Axilla GSP (mg) Standard Deviation 141.738	282.41 Combined Axilla GSP (mg) Standard Deviation 201.920	281.63 Combined Axilla GSP (mg) Standard Deviation 211.542	316.39 Combined Axilla GSP (mg) Standard Deviation 201.478
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 8	137.36 Combined Axilla GSP (mg) Standard Deviation 144.104	124.94 Combined Axilla GSP (mg) Standard Deviation 199.072	113.77 Combined Axilla GSP (mg) Standard Deviation 119.233	118.49 Combined Axilla GSP (mg) Standard Deviation 129.393
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 15	131.50 Combined Axilla GSP (mg) Standard Deviation 100.171	114.24 Combined Axilla GSP (mg) Standard Deviation 175.195	114.07 Combined Axilla GSP (mg) Standard Deviation 169.784	106.68 Combined Axilla GSP (mg) Standard Deviation 121.225
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 22	141.10 Combined Axilla GSP (mg) Standard Deviation 153.886	102.43 Combined Axilla GSP (mg) Standard Deviation 213.006	112.34 Combined Axilla GSP (mg) Standard Deviation 128.033	90.48 Combined Axilla GSP (mg) Standard Deviation 98.380
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 29	114.12 Combined Axilla GSP (mg) Standard Deviation 91.999	106.06 Combined Axilla GSP (mg) Standard Deviation 180.981	168.13 Combined Axilla GSP (mg) Standard Deviation 230.825	117.60 Combined Axilla GSP (mg) Standard Deviation 135.284
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 36	142.87 Combined Axilla GSP (mg) Standard Deviation 156.561	105.16 Combined Axilla GSP (mg) Standard Deviation 200.641	124.33 Combined Axilla GSP (mg) Standard Deviation 147.519	126.44 Combined Axilla GSP (mg) Standard Deviation 231.723
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 41	116.61 Combined Axilla GSP (mg) Standard Deviation 132.620	119.00 Combined Axilla GSP (mg) Standard Deviation 195.636	117.85 Combined Axilla GSP (mg) Standard Deviation 141.070	93.21 Combined Axilla GSP (mg) Standard Deviation 131.063
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 42	110.96 Combined Axilla GSP (mg) Standard Deviation 161.590	95.09 Combined Axilla GSP (mg) Standard Deviation 157.573	111.98 Combined Axilla GSP (mg) Standard Deviation 140.927	88.62 Combined Axilla GSP (mg) Standard Deviation 103.408
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 43	159.13 Combined Axilla GSP (mg) Standard Deviation 157.113	139.65 Combined Axilla GSP (mg) Standard Deviation 291.857	105.03 Combined Axilla GSP (mg) Standard Deviation 108.026	117.34 Combined Axilla GSP (mg) Standard Deviation 159.217
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population Day 57	163.43 Combined Axilla GSP (mg) Standard Deviation 193.565	112.09 Combined Axilla GSP (mg) Standard Deviation 181.185	177.62 Combined Axilla GSP (mg) Standard Deviation 242.634	135.76 Combined Axilla GSP (mg) Standard Deviation 165.620

Adverse Events

Vehicle

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

BBI-4000 Sofpironium Bromide Gel 5%

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

BBI-4000 Sofpironium Bromide Gel 10%

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

BBI-4000 Sofpironium Bromide Gel 15%

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vehicle n=57 participants at risk Vehicle (Placebo), applied to each axilla, once daily	BBI-4000 Sofpironium Bromide Gel 5% n=57 participants at risk BBI-4000 Sofpironium Bromide Gel 5%, applied to each axilla, once daily	BBI-4000 Sofpironium Bromide Gel 10% n=57 participants at risk BBI-4000 Sofpironium Bromide Gel 10%, applied to each axilla, once daily	BBI-4000 Sofpironium Bromide Gel 15% n=54 participants at risk BBI-4000 Sofpironium Bromide Gel 15%, applied to each axilla, once daily
Infections and infestations Staphylococcal osteomyelitis / T8-T9 osteomyelitis/discitis with biopsy positive for streptococcus a	0.00% 0/57 • Treatment-Emergent Adverse Events (TEAEs) were collected from during investigational treatment Days 1 to 42. A safety follow-up assessment including of TEAEs was also performed ~14 days post end of treatment. A total of 225 subjects were included in the Safety population (54 subjects in the 15% group; and 57 subjects each in the 10%, 5%, and vehicle groups). Treatment-Emergent Adverse Events by System Organ Class and Preferred Term (Safety Population)	1.8% 1/57 • Treatment-Emergent Adverse Events (TEAEs) were collected from during investigational treatment Days 1 to 42. A safety follow-up assessment including of TEAEs was also performed ~14 days post end of treatment. A total of 225 subjects were included in the Safety population (54 subjects in the 15% group; and 57 subjects each in the 10%, 5%, and vehicle groups). Treatment-Emergent Adverse Events by System Organ Class and Preferred Term (Safety Population)	0.00% 0/57 • Treatment-Emergent Adverse Events (TEAEs) were collected from during investigational treatment Days 1 to 42. A safety follow-up assessment including of TEAEs was also performed ~14 days post end of treatment. A total of 225 subjects were included in the Safety population (54 subjects in the 15% group; and 57 subjects each in the 10%, 5%, and vehicle groups). Treatment-Emergent Adverse Events by System Organ Class and Preferred Term (Safety Population)	0.00% 0/54 • Treatment-Emergent Adverse Events (TEAEs) were collected from during investigational treatment Days 1 to 42. A safety follow-up assessment including of TEAEs was also performed ~14 days post end of treatment. A total of 225 subjects were included in the Safety population (54 subjects in the 15% group; and 57 subjects each in the 10%, 5%, and vehicle groups). Treatment-Emergent Adverse Events by System Organ Class and Preferred Term (Safety Population)

Other adverse events

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