CompletedPhase 3

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

United States300 participantsStarted 2018-09-05

Plain-language summary

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 long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.

Who can participate

Age range9 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female subject ≥9 years of age in good general health. * Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 3 - 4 inclusive at both the Screening Visit (Visit 1) and Baseline Visit (Visit 2). (b) Symptoms of axillary hyperhidrosis for greater than or equal to 6 months' duration prior to Baseline Visit (Visit 2). Exclusion Criteria: * In the Investigator's opinion, any skin or subcutaneous tissue conditions of the axilla(e), (i.e., the axillary area should be deemed otherwise "normal", besides the hyperhidrosis diagnosis, and free of blisters, large boils or sinus tracts, significant scarring or open wounds). * Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis: (a) Botulinum toxin to the axillary area within 6 months of the Baseline Visit (Visit 2). (b) Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past. (c) Serotonergic agonist (or drugs that increase serotonin activity including SSRIs), beta-blocker, alpha-adrenergic agonist (clonidine), dopamine partial agonist or tricyclic antidepressant treatment within 28 days of the Baseline Visit (Visit 2). However, if a subject has been on a stable dose (in the opinion of the PI) of any of these medications and has not had a recent change in hyperhidrosis frequency or severity for 3 months prior to the Baseline Visit; they…

What they're measuring

The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity

Timeframe: All safety subjects, reaching week 48 or not

Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety)

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

Trial details

NCT IDNCT03627468

SponsorBotanix Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-27

Results submitted2023-02-10

View on ClinicalTrials.gov More Primary Axillary Hyperhidrosis trials