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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03785587
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : August 24, 2021
Information provided by (Responsible Party):
Brickell Biotech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Drug: Sofpironium Bromide Gel, 15% Phase 2

Detailed Description:

This is an open-label, phase 2 long-term study designed to evaluate the safety, local tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied topically to the axillae.

Subjects will apply the gel once daily at bedtime, to both axillae.

A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%.

Adverse events, vital signs, and local tolerability assessments will be collected at each visit. 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 pharmacokinetics, 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 8 scheduled visits to take place over a 26 week period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Pharmacokinetics of Sofpironium Bromide Gel, 15% Applied Topically to Children and Adolescents, ≥9 to <17 Years of Age, Previously Enrolled in BBI-4000-CL-105
Actual Study Start Date : December 21, 2018
Actual Primary Completion Date : September 6, 2019
Actual Study Completion Date : September 6, 2019

Arm Intervention/treatment
Experimental: Gel, 15%
Sofpironium Bromide Gel, 15%, q.d. for 24 weeks
Drug: Sofpironium Bromide Gel, 15%
Sofpironium Bromide Gel, 15%
Other Name: BBI-4000

Primary Outcome Measures :
  1. The number of participants with treatment emergent adverse events. [ Time Frame: Through study completion (24 weeks). ]
    Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.

  2. The number of participants with dermal tolerability symptoms of burning, stinging, itching, scaling or erythema to the axillae. [ Time Frame: Through study completion (24 weeks). ]
    Symptoms rated on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe).

  3. The systemic exposure (Ctrough) of sofpironium and its primary metabolite (BBI-4010) [ Time Frame: Through study completion (24 weeks). ]
    Trough levels of sofpironium based on sampling schedule.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 be altered during the course of the study. (d) Any topical treatment for hyperhidrosis, requiring a prescription, within 3 days of enrollment.
  • Anticholinergic agents [with the exception of sofpironium bromide] used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration (e.g., IV, oral, inhaled, topical) within 30 days of the enrollment.
  • Use of potent oral inhibitors of cytochrome P450 CYP3A & CYP2D6 and transporter inhibitors (OCT2/MATE1/MATE2) 14 days prior to enrollment. The use of topical antifungal medications is permitted if not applied in the treatment area.
  • Any oral or topical homeopathic or herbal treatment (i.e., alternative therapies such as sage tablets, chamomile, valerian root and St. John's Wort) within 14 days of enrollment.
  • Use of any cholinergic drug (e.g., bethanechol) within 30 days of enrollment.
  • Use of any anti-anxiety and/or anti-depressant, amphetamine product or drugs with known anticholinergic side effects is prohibited with the following exceptions: (a) If a subject has been on a stable dose of an anti-anxiety and/or anti-depressant drug and has not had a recent change in hyperhidrosis frequency or severity for 3 months; they may be included. (b) An amphetamine product may be allowed if the dose has been stable for greater than or equal to 6 months without change in hyperhidrosis frequency or severity for 3 months. (c) Drugs with known anticholinergic side effects (taken within the last 30 days), including dry mouth, blurred vision, may be allowed based on the Principal Investigator's assessment.
  • Known causes of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.).
  • Subjects with hyperhidrosis symptoms initiated or exacerbated with menopause.
  • Subjects with 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 in the Investigator's opinion.
  • Known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
  • Subject is pregnant, lactating or is planning to become pregnant during the study.
  • Unable or unwilling to undergo multiple venipunctures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03785587

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United States, Arkansas
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States, 72758
Sponsors and Collaborators
Brickell Biotech, Inc.
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Study Director: Sanjeev Ahuja Brickell Biotech, Inc.
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Responsible Party: Brickell Biotech, Inc. Identifier: NCT03785587    
Other Study ID Numbers: BBI-4000-CL-108
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases