Trial Outcomes & Findings for A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis (NCT NCT02682238)

NCT ID: NCT02682238

Last Updated: 2023-05-19

Results Overview

Each subject counted only once. Severity was rated Mild, Moderate or Severe.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline visit-Day 42 End of Participation
• Results posted on: 2023-05-19

Participant Flow

Participant milestones

Measure	BBI-4000 (Sofpironium Bromide) Gel, 15% BBI-4000 (sofpironium bromide) gel, 15%, one-pump applied to each palm nightly	Vehicle Gel Vehicle (placebo) gel, one-pump applied to each palm nightly
Overall Study STARTED	25	25
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	BBI-4000 (Sofpironium Bromide) Gel, 15% BBI-4000 (sofpironium bromide) gel, 15%, one-pump applied to each palm nightly	Vehicle Gel Vehicle (placebo) gel, one-pump applied to each palm nightly
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse Event	1	0
Overall Study Non-compliance with Study Drug	1	0
Overall Study Non-compliance with Protocol	0	2

Baseline Characteristics

A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis

Baseline characteristics by cohort

Measure	BBI-4000, 15% n=25 Participants 15% BBI-4000 (sofpironium bromide) topical gel BBI-4000, 15%	Vehicle n=25 Participants Vehicle (placebo) gel Vehicle gel	Total n=50 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 30 • n=5 Participants	30.5 years STANDARD_DEVIATION 28 • n=7 Participants	31.1 years STANDARD_DEVIATION 30 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	21 Participants n=7 Participants	38 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline visit-Day 42 End of Participation

Population: Participants receiving applying at least one dose of investigational treatment

Each subject counted only once. Severity was rated Mild, Moderate or Severe.

Outcome measures

Measure	BBI-4000 Gel, 15% n=24 Participants BBI-4000 Sofpironium bromide gel,15% applied once to each palm daily for 28 days	Vehicle Gel (Placebo) n=25 Participants Vehicle gel (placebo), applied once to each palm daily for 28 days
Number of Treatment Emergent Adverse Events by Severity Mild	14 Number of Events by Severity	4 Number of Events by Severity
Number of Treatment Emergent Adverse Events by Severity Moderate	3 Number of Events by Severity	0 Number of Events by Severity
Number of Treatment Emergent Adverse Events by Severity Severe	0 Number of Events by Severity	0 Number of Events by Severity

SECONDARY outcome

Timeframe: Baseline to Day 29 (End of Treatment) Visit

Population: Randomized participants who provided HDSS scores: baseline and day 29

HDSS assessment included a progressive hyperhidrosis severity scale, in which participants would rate the severity of their palmar hyperhidrosis for the past week with one of the following: 1-My sweating is never noticeable and never interfered with my daily activities; 2-My sweating is tolerable but sometimes interferes with my daily activities; 3-My sweating is barely tolerable and frequently interferes with my daily activities; 4-My sweating is intolerable and always interferes with my daily activities

Outcome measures

Measure	BBI-4000 Gel, 15% n=22 Participants BBI-4000 Sofpironium bromide gel,15% applied once to each palm daily for 28 days	Vehicle Gel (Placebo) n=23 Participants Vehicle gel (placebo), applied once to each palm daily for 28 days
Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29 Proportion of Subjects with at least 1-Point Decrease : No	8 Participants	6 Participants
Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29 Proportion of Subjects with at least 1-Point Decrease : Yes	14 Participants	17 Participants
Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29 Proportion of Subjects with at least 2-Point Decrease : No	20 Participants	21 Participants
Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29 Proportion of Subjects with at least 2-Point Decrease : Yes	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline-Day 29 Participation

Population: Randomized participants (to one of two treatment arms) who provided Gravimetrically Measured Sweat Production (GMSP) results (Right and Left Palms) Baseline and day 29

Individual Right and left palm gravimetric measured sweat production results (mg) were combined per participant at Baseline and Day 29 time points. Mean averages of individual absolute GMSP changes (Day 29 Combined GMSP-Baseline Combined GMSP) were compared between the two treatment arms.

Outcome measures

Measure	BBI-4000 Gel, 15% n=88 Palm BBI-4000 Sofpironium bromide gel,15% applied once to each palm daily for 28 days	Vehicle Gel (Placebo) n=92 Palm Vehicle gel (placebo), applied once to each palm daily for 28 days
Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm.	-91.38 mg Standard Deviation 385.12	-156.62 mg Standard Deviation 367.69

SECONDARY outcome

Timeframe: Baseline through day 29 (End of Treatment)

Population: Randomized participants completing baseline through day 29 (End of Treatment) activities. Note: For this analysis, number analyzed includes 22 (gel, 15%) and 23 (Placebo) participants, and 22 (gel, 15%) and 23 (Placebo) participants' % reduction in sweat production for analysis.

Visit combined sweat production (mg) was calculated by combining individual right and left palm gravimetric sweat production results (mg) at Baseline and Day 29 time points. Resulting difference was calculated by: Day 29 Combined GMSP - Baseline Combined GMSP. Percent reduction in sweat production was calculated by: ((Resulting difference GMSP score (mg)) / Baseline GMSP score (mg) x 100). The number of subjects who achieved ≥ 50% reduction in sweat production (YES) were reported, along with the proportion=number of subjects who achieved ≥ 50% reduction in sweat production / total number of subjects providing baseline and day 29 results x 100. The number of subjects who achieved < 50% reduction in sweat production (NO) were reported, along with the proportion=number of subjects who achieved < 50% reduction in sweat production / total number of subjects providing baseline and day 29 results x 100.

Outcome measures

Measure	BBI-4000 Gel, 15% n=88 Palm BBI-4000 Sofpironium bromide gel,15% applied once to each palm daily for 28 days	Vehicle Gel (Placebo) n=92 Palm Vehicle gel (placebo), applied once to each palm daily for 28 days
Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms The number of subjects who achieved < 50% reduction in sweat production (NO)	18 participants	18 participants
Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms The number of subjects who achieved ≥ 50% reduction in sweat production (YES)	4 participants	5 participants

SECONDARY outcome

Timeframe: Baseline-Day 29 End of Treatment

Population: Participants applying at least one dose of investigational treatment to each palm and providing both right \& left palm GMSP results at baseline and day 29. Combined GMSP results were determined by adding GMSP Left Palm + GMSP Right Palm results.

Individual Right and left palm gravimetric sweat production (GMSP) results (mg) were combined per participant at Baseline and Day 29 time points. Mean averages of individual percent change were compared between the two treatment arms. Individual % Change vs. Baseline was determined by: [(D29 Right palm GMSP + D29 Left palm GMSP)-(Baseline Right palm GMSP + Baseline Left palm GMSP)]/(Baseline Right palm GMSP + Baseline Left palm GMSP)]

Outcome measures

Measure	BBI-4000 Gel, 15% n=88 Palm BBI-4000 Sofpironium bromide gel,15% applied once to each palm daily for 28 days	Vehicle Gel (Placebo) n=92 Palm Vehicle gel (placebo), applied once to each palm daily for 28 days
The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms.	-10.56 percentage of change Standard Deviation 52.61	-15.76 percentage of change Standard Deviation 45.05

Adverse Events

BBI-4000, 15%

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BBI-4000, 15% n=24 participants at risk 15% BBI-4000 (sofpironium bromide) topical gel, one pump applied to each palm nightly	Vehicle n=25 participants at risk Vehicle (placebo) gel, one pump applied to each palm nightly
General disorders Application Site Dermatitis	8.3% 2/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
General disorders Application Site Hyperaesthesia	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Eye disorders Blepharitis	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Eye disorders Dry Eye	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Eye disorders Mydriasis	8.3% 2/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Eye disorders Vision Blurred	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Gastrointestinal disorders Constipation	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Gastrointestinal disorders Dry Mouth	8.3% 2/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	4.0% 1/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	4.0% 1/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Cardiac disorders Atrial Fibrillation	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
General disorders Application Site Eczema	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	4.0% 1/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Nervous system disorders Headache	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Renal and urinary disorders Micturition Urgency	4.2% 1/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	0.00% 0/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.
Vascular disorders Hypotension	0.00% 0/24 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.	4.0% 1/25 • Adverse event data was collected from time of consent signature (screening period was ≤ 30 days), baseline, day 29 (end of treatment), through to day 42 (± 3 days) (safety follow-up); overall duration of adverse collection for each participant could be up to 75 days Subjects with Treatment Emergent Adverse Events (TEAEs). The Safety population (N=49) included all subjects enrolled in the study who were dispensed and applied study drug at least once. One subject was excluded from the Safety population because the subject did not apply any study drug.

Additional Information

Anthony Robinson, MS, CRNP

Botanix Pharmaceuticals

Phone: +1 (445) 300-3403

Email: trials@botanixpharma.com

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