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

NCT ID: NCT03024255

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-22
• Study Completion Date: 2017-09-19

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.

Conditions

Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BBI-4000 gel, 5%

BBI-4000 gel, 5% applied once to each axilla daily

Group Type: EXPERIMENTAL

BBI-4000 gel, 5%

Intervention Type: DRUG

BBI-4000 gel, 5% applied once to each axilla daily

BBI-4000 gel, 10%

BBI-4000 gel, 10% applied once to each axilla daily

Group Type: EXPERIMENTAL

BBI-4000 gel, 10%

Intervention Type: DRUG

BBI-4000 gel, 10% applied once to each axilla daily

BBI-4000 gel, 15%

BBI-4000 gel, 15% applied once to each axilla daily

Group Type: EXPERIMENTAL

BBI-4000 gel, 15%

Intervention Type: DRUG

BBI-4000 gel, 15% applied once to each axilla daily

Vehicle

Placebo, applied once to each axilla daily

Group Type: PLACEBO_COMPARATOR

Vehicle (Placebo)

Intervention Type: DRUG

Placebo, applied once to each axilla daily

Interventions

BBI-4000 gel, 5%

BBI-4000 gel, 5% applied once to each axilla daily

Intervention Type: DRUG

BBI-4000 gel, 10%

BBI-4000 gel, 10% applied once to each axilla daily

Intervention Type: DRUG

BBI-4000 gel, 15%

BBI-4000 gel, 15% applied once to each axilla daily

Intervention Type: DRUG

Vehicle (Placebo)

Placebo, applied once to each axilla daily

Intervention Type: DRUG

Other Intervention Names

BBI-4000 Low Concentration; BBI-4000 Medium Concentration; BBI-4000 High Concentration; Control

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Botanix Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Walker, MD PhD

Role: STUDY_DIRECTOR

Botanix Pharmaceuticals

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BBI-4000-CL-203

Identifier Type: -

Identifier Source: org_study_id