Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar Hyperhidrosis.
Participating subjects will apply either BBI-4000 15% or vehicle gel topically to the palms of both hands once daily for 4 consecutive weeks. The 4 week treatment period will be followed by a 2 week follow-up period.
Safety and tolerability will be assessed through collection of vital signs, adverse events, assessment of local skin responses, ECG, UPT and blood sampling.
Efficacy will be assessed through gravimetric sweat assessments as well as through the Hyperhidrosis Disease Severity Scale (HDSS).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBI-4000, 15% | Experimental | 15% BBI-4000 (sofpironium bromide) topical gel |
|
| Vehicle | Placebo Comparator | Vehicle (placebo) gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBI-4000, 15% | Drug |
| ||
| Vehicle gel |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events by Severity | Each subject counted only once. Severity was rated Mild, Moderate or Severe. | Baseline visit-Day 42 End of Participation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any skin or subcutaneous tissue conditions of the palms, other than hyperhidrosis
Prior use of any prohibited medication(s) or procedure(s) within specified timeframe for the treatment of palmar hyperhidrosis, including:
Use of anticholinergic agents within 30 days of baseline visit
Any oral or topical homeopathic or herbal treatment within 30 days of baseline visit
Use of any cholinergic drug within 30 days of baseline visit
Use of any anti-anxiety and/or anti-depressant, amphetamine products or drugs with known anticholinergic side effects
Hyperhidrosis secondary to any known cause
Subjects with history of unstable type 1 or type 2 diabetes mellitus or thyroid disease, history of renal impairment, hepatic impairment, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics.
Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
Pregnant or lactating women.
Use of an investigational drug within 30 days prior to the baseline visit.
Any major illness within 30 days before the screening examination.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TCR Medical Corporation | San Diego | California | 92123 | United States | ||
| International Dermatology Research, Inc. |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BBI-4000 (Sofpironium Bromide) Gel, 15% | BBI-4000 (sofpironium bromide) gel, 15%, one-pump applied to each palm nightly |
| FG001 | Vehicle Gel | Vehicle (placebo) gel, one-pump applied to each palm nightly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BBI-4000, 15% | 15% BBI-4000 (sofpironium bromide) topical gel BBI-4000, 15% |
| BG001 | Vehicle | Vehicle (placebo) gel Vehicle gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events by Severity | Each subject counted only once. Severity was rated Mild, Moderate or Severe. | Participants receiving applying at least one dose of investigational treatment | Posted | Number | Number of Events by Severity | Baseline visit-Day 42 End of Participation |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BBI-4000, 15% | 15% BBI-4000 (sofpironium bromide) topical gel, one pump applied to each palm nightly |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Dermatitis | General disorders | MedDRA (19.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Robinson, MS, CRNP | Botanix Pharmaceuticals | +1 (445) 300-3403 | trials@botanixpharma.com |
Not provided
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Baseline to Day 29 (End of Treatment) Visit |
| Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm. | 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. | Baseline-Day 29 Participation |
| Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms | 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. | Baseline through day 29 (End of Treatment) |
| The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms. | 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)] | Baseline-Day 29 End of Treatment |
| Miami |
| Florida |
| 33144 |
| United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| Saint Louis University Dermatology | St Louis | Missouri | 63122 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Adverse Event |
|
| Non-compliance with Study Drug |
|
| Non-compliance with Protocol |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to 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 | Randomized participants who provided HDSS scores: baseline and day 29 | Posted | Count of Participants | Participants | Baseline to Day 29 (End of Treatment) Visit |
|
|
|
| Secondary | Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm. | 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. | Randomized participants (to one of two treatment arms) who provided Gravimetrically Measured Sweat Production (GMSP) results (Right and Left Palms) Baseline and day 29 | Posted | Mean | Standard Deviation | mg | Baseline-Day 29 Participation | Palm | Palm |
|
|
|
| Secondary | Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms | 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. | 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. | Posted | Number | participants | Baseline through day 29 (End of Treatment) | Palm | Palm |
|
|
|
| Secondary | The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms. | 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)] | 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. | Posted | Mean | Standard Deviation | percentage of change | Baseline-Day 29 End of Treatment | Palm | Palm |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 8 |
| 24 |
| EG001 | Vehicle | Vehicle (placebo) gel, one pump applied to each palm nightly | 0 | 25 | 0 | 25 | 4 | 25 |
| Application Site Hyperaesthesia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Mydriasis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Application Site Eczema | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Micturition Urgency | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
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 .
| Proportion of Subjects with at least 2-Point Decrease : No |
|
| Proportion of Subjects with at least 2-Point Decrease : Yes |
|