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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: BBI-4000 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Strength BBI-4000 and Vehicle Drug: BBI-4000
Experimental: High Strength BBI-4000 and Vehicle Drug: BBI-4000


Outcome Measures
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Primary Outcome Measures :
  1. Percent change in the gravimetrically measured sweat production from baseline [ Time Frame: Week 2 ]

Secondary Outcome Measures :
  1. Absolute change in the gravimetrically measured sweat production from baseline [ Time Frame: Week 2 ]
  2. Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline. [ Time Frame: Week 2 ]
  3. Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline [ Time Frame: Week 2 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02058264


Locations
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Dominican Republic
Instituto Dermatologico
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Brickell Biotech, Inc.
Investigators
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Study Director: David Angulo, M.D. Brickell Biotech, Inc.
Principal Investigator: Daisy Blanco, M.D. Instituto Dermatologico
More Information
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Responsible Party: Brickell Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02058264    
Other Study ID Numbers: BBI-4000-CL-101
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases