CompletedPhase 2

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

United States21 participantsStarted 2018-12-21

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. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.

Who can participate

Age range

9 Years – 16 Years

Sex

ALL

See this in plain English?

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 to \<17 years of age in good general health. * Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 2 - 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 enrollment. 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 9 months of enrollment. (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 30 days of enrollment. 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 enrollment; they may be included. Doses of these agents should not…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).

Timeframe: Through study completion (24 weeks).

The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.

Timeframe: Through study completion (24 weeks).

The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)

Timeframe: Through study completion (24 weeks).

Trial details

NCT IDNCT03785587

SponsorBotanix Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-06

Results submitted2022-12-22

View on ClinicalTrials.gov More Primary Axillary Hyperhidrosis trials

Plain-language summary

Who can participate

Age range

9 Years – 16 Years

Sex

ALL

See this in plain English?

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

What they're measuring

The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).

Timeframe: Through study completion (24 weeks).

The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.

Timeframe: Through study completion (24 weeks).

The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)

Timeframe: Through study completion (24 weeks).