ClinicalTrials.gov

History of Changes for Study: NCT03024255
A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Latest version (submitted July 18, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 January 13, 2017 None (earliest Version on record)
2 July 13, 2017 Recruitment Status, Study Status and Contacts/Locations
3 January 17, 2018 Recruitment Status, Study Status and Study Design
4 July 18, 2018 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03024255
Submitted Date:  January 13, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: BBI-4000-CL-203
Brief Title: A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2017
Overall Status: Recruiting
Study Start: December 2016
Primary Completion: June 2017 [Anticipated]
Study Completion: September 2017 [Anticipated]
First Submitted: January 6, 2017
First Submitted that
Met QC Criteria:
January 13, 2017
First Posted: January 18, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 13, 2017
Last Update Posted: January 18, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Fresh Tracks Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Hyperhidrosis
Keywords: sweat gland disease
sweating
underarm
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 220 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BBI-4000 Concentration 1
Low Concentration
Drug: BBI-4000 Concentration 1
Lowest test dose
Other Names:
  • BBI-4000 Low Concentration
Experimental: BBI-4000 Concentration 2
Medium Concentration
Drug: BBI-4000 Concentration 2
Test dose between high and low concentrations
Other Names:
  • BBI-4000 Medium Concentration
Experimental: BBI-4000 Concentration 3
High Concentration
Drug: BBI-4000 Concentration 3
Highest test dose
Other Names:
  • BBI-4000 High Concentration
Placebo Comparator: Vehicle
Vehicle (Placebo)
Drug: Vehicle (Placebo)
Vehicle without drug
Other Names:
  • Control
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: IHHS Agent
Telephone: 866-727-9328
Study Officials: Lawrence A Romel, MS
Study Director
Fresh Tracks Therapeutics, Inc.
Locations: United States, South Carolina
IHHS Call Center
[Recruiting]
Charleston, South Carolina, United States, 29492
Contact:Contact: 866-727-9328
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services