A Phase 2 interventional study of BBI-4000, 15% and Vehicle gel in Hyperhidrosis, sponsored by Botanix Pharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Botanix Pharmaceuticals · Phase 2, Interventional, and Treatment
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).
112 studies on the registry are indexed under Hyperhidrosis; 9 are open to participants now.
This study's enrollment of 50 is close to the median of 51 across 100 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Botanix Pharmaceuticals is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
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Exclusion Criteria:
Prior use of any prohibited medication(s) or procedure(s) within specified timeframe for the treatment of palmar hyperhidrosis, including:
15% BBI-4000 (sofpironium bromide) topical gel
Drug: BBI-4000, 15%
Vehicle (placebo) gel
Other: Vehicle gel
Also known as: Placebo gel
Number of Treatment Emergent Adverse Events by Severity
Each subject counted only once. Severity was rated Mild, Moderate or Severe.
Time frame: Baseline visit-Day 42 End of Participation
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
Time frame: 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.
Time frame: 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.
Time frame: 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)\]
Time frame: Baseline-Day 29 End of Treatment
| Milestone | BBI-4000 (Sofpironium Bromide) Gel, 15% | Vehicle Gel |
|---|---|---|
| Started | 25 | 25 |
| Completed | 22 | 21 |
| Not completed | 3 | 4 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Non-compliance with study drug | 1 | 0 |
| Withdrew: Non-compliance with protocol | 0 | 2 |
Each subject counted only once. Severity was rated Mild, Moderate or Severe.
| Number of Events by Severity | BBI-4000 Gel, 15% | Vehicle Gel (Placebo) |
|---|---|---|
| Mild | 14 | 4 |
| Moderate | 3 | 0 |
| Severe | 0 | 0 |
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
| Participants | BBI-4000 (Sofpironium Bromide) Gel, 15% | Vehicle Gel (Placebo) |
|---|---|---|
| Proportion of Subjects with at least 1-Point Decrease : No | 8 | 6 |
| Proportion of Subjects with at least 1-Point Decrease : Yes | 14 | 17 |
| Proportion of Subjects with at least 2-Point Decrease : No | 20 | 21 |
| Proportion of Subjects with at least 2-Point Decrease : Yes | 2 | 2 |
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.
| mg | BBI-4000 (Sofpironium Bromide) Gel, 15% | Vehicle Gel (Placebo) |
|---|---|---|
| Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm. | -91.38 ± 385.12 | -156.62 ± 367.69 |
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.
| participants | BBI-4000 Sofpironium Bromide Gel, 15% | Vehicle Gel, (Placebo) |
|---|---|---|
| The number of subjects who achieved < 50% reduction in sweat production (NO) | 18 | 18 |
| The number of subjects who achieved ≥ 50% reduction in sweat production (YES) | 4 | 5 |
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)\]
| percentage of change | BBI-4000 (Sobpironium Bromide) Gel, 15% | Vehicle Gel |
|---|---|---|
| The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms. | -10.56 ± 52.61 | -15.76 ± 45.05 |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BBI-4000, 15% | 0/24 (0%) | 0/24 (0%) | 8/24 (33.3%) |
| Vehicle | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| Event | BBI-4000, 15% | Vehicle |
|---|---|---|
| Application Site DermatitisGeneral disorders | 2/24 | 0/25 |
| MydriasisEye disorders | 2/24 | 0/25 |
| Dry MouthGastrointestinal disorders | 2/24 | 0/25 |
| Application Site HyperaesthesiaGeneral disorders | 1/24 | 0/25 |
| BlepharitisEye disorders | 1/24 | 0/25 |
| Dry EyeEye disorders | 1/24 | 0/25 |
| Vision BlurredEye disorders | 1/24 | 0/25 |
| ConstipationGastrointestinal disorders | 1/24 | 0/25 |
| Nasal DrynessRespiratory, thoracic and mediastinal disorders | 1/24 | 0/25 |
| Atrial FibrillationCardiac disorders | 1/24 | 0/25 |
Intent-to-Treat Population
| Age, Continuous(years) | BBI-4000, 15% | Vehicle | Total |
|---|---|---|---|
| Mean | 31.7 ± 30 | 30.5 ± 28 | 31.1 ± 30 |
| Sex: Female, Male(Participants) | BBI-4000, 15% | Vehicle | Total |
|---|---|---|---|
| Female | 21 | 20 | 41 |
| Male | 4 | 5 | 9 |
| Ethnicity (NIH/OMB)(Participants) | BBI-4000, 15% | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 7 | 10 |
| Not Hispanic or Latino | 22 | 18 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BBI-4000, 15% | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 17 | 21 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sofpironium
Botanix Pharmaceuticals