A Phase 3 interventional study of Sofpironium Bromide, 15% and Vehicle in Axillary Hyperhidrosis, sponsored by Botanix Pharmaceuticals. Completed at 42 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Botanix Pharmaceuticals · Phase 3, Interventional, and Treatment
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands.
Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.
This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel in subjects with axillary hyperhidrosis.
Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.
A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle.
Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points.
The study will be comprised of a total of 13 scheduled visits to take place over approximately 11 to 15 weeks.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 351 is above the median of 50 across 99 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sofpironium bromide, 15% gel, once per day
Drug: Sofpironium Bromide, 15%
Vehicle gel, once per day
Drug: Vehicle
Active
Also known as: BBI-4000, 15%
Vehicle gel
Also known as: BBI-4000, 0%
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 \[better\] - 4 \[worse\]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment \[6 weeks\] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
Time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment
Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right +left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed. Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4. End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12. The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment \[6 weeks\] minus ranked GSP at baseline) was used as the outcome value.
Time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
| Milestone | Active | Vehicle |
|---|---|---|
| Started | 180 | 171 |
| Completed | 160 | 155 |
| Not completed | 20 | 16 |
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 \[better\] - 4 \[worse\]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment \[6 weeks\] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
| Participants | Active | Vehicle |
|---|---|---|
| Number of Participants YES Observed ≥2-point improvement | 108 | 75 |
| Number of Participants NO Observed ≥2-point improvement | 54 | 84 |
Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right +left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed. Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4. End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12. The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment \[6 weeks\] minus ranked GSP at baseline) was used as the outcome value.
| milligrams | Active | Vehicle |
|---|---|---|
| Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment | -29.85 ± 93.190 | -7.22 ± 93.255 |
Collected over 11-15 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/180 (0%) | 1/180 (0.6%) | 80/180 (44.4%) |
| Vehicle | 0/171 (0%) | 0/171 (0%) | 9/171 (5.3%) |
| Event | Active | Vehicle |
|---|---|---|
| AppendicitisInfections and infestations | 1/180 | 0/171 |
| Event | Active | Vehicle |
|---|---|---|
| Dry MouthGastrointestinal disorders | 31/180 | 2/171 |
| Vision BlurredEye disorders | 21/180 | 1/171 |
| Application Site PainGeneral disorders | 18/180 | 2/171 |
| Application Site ErythemaGeneral disorders | 14/180 | 0/171 |
| Application Site DermatitisGeneral disorders | 10/180 | 0/171 |
| MydriasisEye disorders | 9/180 | 0/171 |
| Application Site IrritationGeneral disorders | 6/180 | 1/171 |
| Dry EyeEye disorders | 6/180 | 0/171 |
| Urinary RetentionRenal and urinary disorders | 6/180 | 0/171 |
| Application Site PruritisGeneral disorders | 4/180 | 1/171 |
Intent-to-treat
| Age, Continuous(years) | Active | Vehicle | Total |
|---|---|---|---|
| Mean | 32.1 ± 12.22 | 31.7 ± 11.13 | 31.9 ± 11.67 |
| Age, Customized(Participants) | Active | Vehicle | Total |
|---|---|---|---|
| 9-12 Years | 4 | 2 | 6 |
| 13-16 Years | 9 | 5 | 14 |
| 17-30 Years | 77 | 83 | 160 |
| ≥31 Years | 90 | 81 | 171 |
| Sex: Female, Male(Participants) | Active | Vehicle | Total |
|---|---|---|---|
| Female | 92 | 103 | 195 |
| Male | 88 | 68 | 156 |
| Ethnicity (NIH/OMB)(Participants) | Active | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 48 | 45 | 93 |
| Not Hispanic or Latino | 132 | 124 | 256 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Active | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 32 | 34 | 66 |
| White | 141 | 133 | 274 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Time since start of Axillary Hyperhidrosis symptoms(Months) | Active | Vehicle | Total |
|---|---|---|---|
| Mean | 202.58 ± 131.948 | 194.36 ± 117.303 | 198.47 ± 124.672 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Aug 2021, 8 months.
Results were first posted in May 2024, 2 years 9 months after primary completion. A results delay was requested in Jan 2022.
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Studies of the drug tested here: Sofpironium
Botanix Pharmaceuticals