We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects 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.
ClinicalTrials.gov Identifier: NCT03024255
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : July 20, 2018
Information provided by (Responsible Party):
Fresh Tracks Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: BBI-4000 Concentration 1 Drug: BBI-4000 Concentration 2 Drug: BBI-4000 Concentration 3 Drug: Vehicle (Placebo) Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 Concentrations of Topically Applied BBI-4000 (Sofpironium Bromide) Gel in Subjects With Axillary Hyperhidrosis
Study Start Date : December 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: BBI-4000 Concentration 1
Low Concentration
Drug: BBI-4000 Concentration 1
Lowest test dose
Other Name: BBI-4000 Low Concentration

Experimental: BBI-4000 Concentration 2
Medium Concentration
Drug: BBI-4000 Concentration 2
Test dose between high and low concentrations
Other Name: BBI-4000 Medium Concentration

Experimental: BBI-4000 Concentration 3
High Concentration
Drug: BBI-4000 Concentration 3
Highest test dose
Other Name: BBI-4000 High Concentration

Placebo Comparator: Vehicle
Vehicle (Placebo)
Drug: Vehicle (Placebo)
Vehicle without drug
Other Name: Control

Primary Outcome Measures :
  1. Hyperhydrosis severity questionnaire [ Time Frame: 6 Weeks ]
    An 11 question evaluation tool to assess the effect of BBI-4000 5%, 10% and 15 % gel on hyperhidrosis disease severity measure when applied topically in subjects with axillary hyperhidrosis.

  2. Adverse events, local tolerability assessments, vital signs and laboratory tests [ Time Frame: 6 Weeks ]
    Evaluation of the safety and local tolerability of 3 concentrations of BBI-4000 gel when applied topically in subjects with axillary hyperhidrosis.

Secondary Outcome Measures :
  1. Gravimetric sweat production [ Time Frame: 6 Weeks ]
    Measured weight of the amount of sweat produced

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03024255

Layout table for location information
United States, South Carolina
IHHS Call Center
Charleston, South Carolina, United States, 29492
Sponsors and Collaborators
Fresh Tracks Therapeutics, Inc.
Layout table for investigator information
Study Director: Lawrence A Romel, MS Fresh Tracks Therapeutics, Inc.
Layout table for additonal information
Responsible Party: Fresh Tracks Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03024255    
Other Study ID Numbers: BBI-4000-CL-203
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fresh Tracks Therapeutics, Inc.:
sweat gland disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Sweat Gland Diseases
Skin Diseases