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Trial record 4 of 174 for:    "Sweat Gland Disease"

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

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ClinicalTrials.gov Identifier: NCT03024255
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Brickell Biotech, 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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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


Locations
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United States, South Carolina
IHHS Call Center
Charleston, South Carolina, United States, 29492
Sponsors and Collaborators
Brickell Biotech, Inc.
Investigators
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Study Director: Lawrence A Romel, MS Brickell Biotech, Inc.

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Responsible Party: Brickell Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03024255     History of Changes
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 Brickell Biotech, Inc.:
sweat gland disease
sweating
underarm
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases