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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
Sponsor:
Information provided by (Responsible Party):
Fresh Tracks Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 18, 2017
Last Update Posted Date July 20, 2018
Study Start Date  ICMJE December 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
Gravimetric sweat production [ Time Frame: 6 Weeks ]
Measured weight of the amount of sweat produced
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperhidrosis
Intervention  ICMJE
  • Drug: BBI-4000 Concentration 1
    Lowest test dose
    Other Name: BBI-4000 Low Concentration
  • Drug: BBI-4000 Concentration 2
    Test dose between high and low concentrations
    Other Name: BBI-4000 Medium Concentration
  • Drug: BBI-4000 Concentration 3
    Highest test dose
    Other Name: BBI-4000 High Concentration
  • Drug: Vehicle (Placebo)
    Vehicle without drug
    Other Name: Control
Study Arms  ICMJE
  • Experimental: BBI-4000 Concentration 1
    Low Concentration
    Intervention: Drug: BBI-4000 Concentration 1
  • Experimental: BBI-4000 Concentration 2
    Medium Concentration
    Intervention: Drug: BBI-4000 Concentration 2
  • Experimental: BBI-4000 Concentration 3
    High Concentration
    Intervention: Drug: BBI-4000 Concentration 3
  • Placebo Comparator: Vehicle
    Vehicle (Placebo)
    Intervention: Drug: Vehicle (Placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2018)
227
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2017)
220
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03024255
Other Study ID Numbers  ICMJE BBI-4000-CL-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Fresh Tracks Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fresh Tracks Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lawrence A Romel, MS Fresh Tracks Therapeutics, Inc.
PRS Account Fresh Tracks Therapeutics, Inc.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP