Trial Outcomes & Findings for A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis (NCT NCT03627468)

Last Updated: 2023-05-19

Results Overview

The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

300 participants

Primary outcome timeframe

All safety subjects, reaching week 48 or not

Results posted on

2023-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Gel, 5% Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
Overall Study STARTED	103	197
Overall Study COMPLETED	72	118
Overall Study NOT COMPLETED	31	79

Reasons for withdrawal

Reasons for withdrawal
Measure	Gel, 5% Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
Overall Study Adverse Event	5	33
Overall Study Withdrawal by Subject	13	23
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	0	2
Overall Study Lost to Follow-up	10	16
Overall Study Death	1	0
Overall Study Pregnancy	1	1
Overall Study Lack of Efficacy	0	2
Overall Study Poor Compliance or Noncompliance	0	2

Baseline Characteristics

A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gel, 5% n=103 Participants Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=197 Participants Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%	Total n=300 Participants Total of all reporting groups
Age, Customized 9-12 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 13-16 years	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Age, Customized ≥17 years	99 Participants n=5 Participants	183 Participants n=7 Participants	282 Participants n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	121 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	76 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	39 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	157 Participants n=7 Participants	233 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	47 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	143 Participants n=7 Participants	217 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
HDSM-Ax-11 Scale Score Summary - Baseline Visit	3.57 units on a scale STANDARD_DEVIATION 0.308 • n=5 Participants	3.56 units on a scale STANDARD_DEVIATION 0.316 • n=7 Participants	3.565 units on a scale STANDARD_DEVIATION 0.312 • n=5 Participants

PRIMARY outcome

Timeframe: All safety subjects, reaching week 48 or not

Population: Overall number of participants analyzed included the Safety Population. Subunits: Subjects reporting any TEAE made up the overall number of units analyzed.

The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe

Outcome measures

Outcome measures
Measure	Gel, 5% n=102 Participants Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=197 Participants Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity Mild Severity	27 Participants	55 Participants
The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity Moderate Severity	29 Participants	58 Participants
The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity Severe Severity	2 Participants	17 Participants
The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity Missing	0 Participants	0 Participants
The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity No TEAE Reported	44 Participants	67 Participants

PRIMARY outcome

Timeframe: All Safety Subject, Baseline-Through study completion (48 weeks) or Not

Population: Safety population, units analyzed: subject incidence of report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rating either as Absent or Minimal, Mild, Moderate or Severe. Subjects where local tolerability assessment was not completed were also included.

Number of participants reporting: local tolerability symptoms and severity (worst) symptom ratings; Incidence by subject report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rated either as Absent or Minimal, Mild, Moderate or Severe.

Outcome measures

Outcome measures
Measure	Gel, 5% n=102 Participants Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=197 Participants Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) Moderate	12 participants	38 participants
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) Severe	4 participants	19 participants
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) Absent	31 participants	59 participants
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) Minimal	34 participants	41 participants
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) Mild	20 participants	37 participants
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety) Subject Tolerability Assessment not Performed	1 participants	3 participants

SECONDARY outcome

Timeframe: From baseline to each visit through study completion (48 weeks)

Population: ITT population and subjects with Baseline-End of Treatment HDSM-Ax-11© scores

HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease in subjects with axillary hyperhidrosis. Two questions measured 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 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11total scores) reflected improvement in HDSM-Ax-11© score and condition.

Outcome measures

Outcome measures
Measure	Gel, 5% n=72 Participants Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=113 Participants Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score Observed ≥1- point HDSM-AX-11 decrease: YES	61 Participants	95 Participants
The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score Observed ≥1- point HDSM-AX-11 decrease: NO	11 Participants	18 Participants

SECONDARY outcome

Timeframe: From baseline to each visit through study completion (48 weeks)

Population: ITT population and subjects with Baseline-End of Treatment HDSM-Ax-11© scores

HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease 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 individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11scores) reflected improvement in HDSM-Ax-11© score and condition.

Outcome measures

Outcome measures
Measure	Gel, 5% n=72 Participants Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=113 Participants Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
The Number (%) of Subjects Achieving (-) ≥ 1.5 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score Observed ≥1.5 - point HDSM-AX-11 decrease: YES	55 Participants	80 Participants
The Number (%) of Subjects Achieving (-) ≥ 1.5 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score Observed ≥1.5 - point HDSM-AX-11 decrease: NO	17 Participants	33 Participants

SECONDARY outcome

Timeframe: From baseline to each visit through study completion (48 weeks)

Population: ITT population and subjects with Baseline-End of Treatment HDSM-Ax-11© scores

Outcome measures

Outcome measures
Measure	Gel, 5% n=72 Participants Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=113 Participants Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score Observed ≥2- point HDSM-AX-11 decrease: YES	51 Participants	70 Participants
The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score Observed ≥2- point HDSM-AX-11 decrease: NO	21 Participants	43 Participants

Adverse Events

Gel, 5%

Serious events: 1 serious events

Other events: 58 other events

Deaths: 1 deaths

Gel, 15%

Serious events: 4 serious events

Other events: 131 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gel, 5% n=102 participants at risk Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=197 participants at risk Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
Psychiatric disorders Depression	0.00% 0/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.51% 1/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Psychiatric disorders Suicide Attempt	0.00% 0/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.51% 1/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Pneumonia	0.98% 1/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.00% 0/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Septic Shock	0.98% 1/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.00% 0/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac Myxoma	0.00% 0/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.51% 1/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.51% 1/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.

Other adverse events

Additional Information

Anthony Robinson, MS, MBA, 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

Measure	Gel, 5% n=102 participants at risk Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5%	Gel, 15% n=197 participants at risk Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%
General disorders Application site pruritus	5.9% 6/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	14.7% 29/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
General disorders Application site pain	3.9% 4/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	14.7% 29/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
General disorders Application site dermatitis	5.9% 6/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	10.7% 21/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
General disorders Application site erythema	5.9% 6/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	7.6% 15/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
General disorders Application site irritation	4.9% 5/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	5.6% 11/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
General disorders Application site rash	0.98% 1/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	4.1% 8/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
General disorders Application site exfoliation	2.0% 2/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	3.0% 6/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
General disorders Application site dryness	0.00% 0/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	2.0% 4/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Upper respiratory tract infection	8.8% 9/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	4.1% 8/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Nasopharyngitis	4.9% 5/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	1.5% 3/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Viral upper respiratory tract infection	3.9% 4/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	2.0% 4/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Influenza	2.0% 2/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	2.0% 4/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Application site folliculitis	0.00% 0/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	2.5% 5/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Infections and infestations Pneumonia	2.9% 3/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.00% 0/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Gastrointestinal disorders Dry Mouth	8.8% 9/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	16.8% 33/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Eye disorders Vision Blurred	4.9% 5/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	18.8% 37/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Eye disorders Mydriasis	0.98% 1/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	5.1% 10/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Eye disorders Dry eye	0.98% 1/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	3.6% 7/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Renal and urinary disorders Urinary retention	2.9% 3/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	3.6% 7/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Musculoskeletal and connective tissue disorders Back pain	4.9% 5/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	0.00% 0/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Nervous system disorders Headache	0.98% 1/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	2.0% 4/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Vascular disorders Hypertension	0.98% 1/102 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.	2.5% 5/197 • Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.