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A Safety, Tolerability and Preliminary 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: NCT02058264
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Brickell Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE February 10, 2014
Last Update Posted Date September 11, 2014
Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Percent change in the gravimetrically measured sweat production from baseline [ Time Frame: Week 2 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • Absolute change in the gravimetrically measured sweat production from baseline [ Time Frame: Week 2 ]
  • Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline. [ Time Frame: Week 2 ]
  • Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline [ Time Frame: Week 2 ]
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 Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Official Title  ICMJE A Randomized, Double Blinded, Vehicle-Controlled Study to Evaluate the Safety and the Effect on Sweat Production of Topically Applied BBI-4000 in Subjects With Hyperhidrosis.
Brief Summary The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.
Detailed Description

This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days.

Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology).

Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS).

Pharmacokinetic information will also be collected.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperhidrosis
Intervention  ICMJE Drug: BBI-4000
Study Arms  ICMJE
  • Experimental: Low Strength BBI-4000 and Vehicle
    Intervention: Drug: BBI-4000
  • Experimental: High Strength BBI-4000 and Vehicle
    Intervention: Drug: BBI-4000
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
Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)
24
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
18
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female subjects from 18 to 45 years of age in good general health.
  • Primary axillary hyperhidrosis of at least 6 months duration.
  • Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
  • Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
  • Use of a medically appropriate contraceptive method.

Exclusion Criteria:

  • Prior axillary use of botulinum toxin within 2 years of study entry.
  • Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
  • Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
  • Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
  • History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
  • Known condition that may cause hyperhidrosis.
  • Use of an investigational drug within 30 days prior to entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Dominican Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02058264
Other Study ID Numbers  ICMJE BBI-4000-CL-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brickell Biotech, Inc.
Study Sponsor  ICMJE Brickell Biotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Angulo, M.D. Brickell Biotech, Inc.
Principal Investigator: Daisy Blanco, M.D. Instituto Dermatologico
PRS Account Brickell Biotech, Inc.
Verification Date September 2014

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