A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

Phase 2

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: BBI-4000 gel, 5%; Drug: BBI-4000 gel, 10%; Drug: Vehicle (Placebo); Drug: BBI-4000 gel, 15%

• Registration Number: NCT03024255
• Lead Sponsor: Botanix Pharmaceuticals

Brief Summary

This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.

Detailed Description

This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 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.

Study Timeline

• Study Start: 2016-12-22
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Primary Completion: 2017-09-19
• Study Completion: 2017-09-19
• Disposition First Submitted: 2018-07-17
• Disposition First Submitted QC: 2018-07-18
• Disposition First Posted: 2018-07-20
• Results First Submitted: 2022-12-20
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Results First Posted: 2023-05-16
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• Male or female subject ≥ 18 years of age.
• Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c) HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg.
• The ability to understand and follow all study-related procedures including study drug administration.
• Sexually active female of childbearing potential (FOCBP)* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product.

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Exclusion Criteria

• In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s).
• Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis.
• Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration.
• Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6.
• Use of any cholinergic drug (e.g. bethanechol) within 30 days.
• Known cause 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 unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions, Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion.
• Subjects with 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.
• History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BBI-4000 gel, 5%	BBI-4000 gel, 5%	BBI-4000 gel, 5% applied once to each axilla daily
BBI-4000 gel, 10%	BBI-4000 gel, 10%	BBI-4000 gel, 10% applied once to each axilla daily
Vehicle	Vehicle (Placebo)	Placebo, applied once to each axilla daily
BBI-4000 gel, 15%	BBI-4000 gel, 15%	BBI-4000 gel, 15% applied once to each axilla daily

Primary Outcome Measures

Name	Time	Method
Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity	Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)	Subjects reporting more than one adverse event are counted only once using the highest severity.
Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy	overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.	11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).; The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax

Secondary Outcome Measures

Name	Time	Method
Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population	Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57	Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed.; Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.