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Trial record 43 of 166 for:    "Sweat Gland Disease"

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

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ClinicalTrials.gov Identifier: NCT02336503
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Brickell Biotech, Inc.

Brief Summary:
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: BBI-4000 Low Concentration Drug: BBI-4000 Middle Concentration Drug: BBI-4000 High Concentration Drug: 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.

Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period.

Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs.

Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production.

PK blood samples will be taken from study subjects from selected centers.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: BBI-4000 Dose 1
Low concentration of BBI-4000
Drug: BBI-4000 Low Concentration
BBI-4000 Low Dose

Experimental: BBI-4000 Dose 2
Middle concentration of BBI-4000
Drug: BBI-4000 Middle Concentration
BBI-4000 Middle Dose

Experimental: BBI-4000 Dose 3
High concentration of BBI-4000
Drug: BBI-4000 High Concentration
BBI-4000 High Dose

Placebo Comparator: Vehicle
Vehicle (placebo)
Drug: Placebo
Vehicle




Primary Outcome Measures :
  1. Proportion of subjects achieving at least 2-point improvement in HDSS from baseline to Week 4 [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving at least 1-point improvement in HDSS from Baseline to Week 4 [ Time Frame: Week 4 ]
  2. Absolute change in gravimetrically measured sweat production from Baseline to Week 4 [ Time Frame: Week 4 ]
  3. Percent Change in gravimetrically measured sweat production from Baseline to Week 4 [ Time Frame: Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary axillary hyperhidrosis of at least 6 months's duration
  • Hyperhidrosis disease severity score of 3 or 4 at baseline
  • Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature)
  • Willing to refrain from using any other antiperspirant agent for the duration of the study.
  • Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study.

Exclusion Criteria:

  • Any skin or subcutaneous tissue conditions in the axilla or near the axillary area, other than hyperhidrosis.
  • Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including:

    1. Botulinum toxin to the axillary area within 1 year of the baseline visit.
    2. Axillary iontophoresis within 12 weeks of baseline visit.
    3. Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past.
  • Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit.
  • Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause.
  • Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics.
  • Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
  • Pregnant or lactating women.
  • Use of an investigational drug within 30 days prior to the baseline visit.
  • Prior treatment with the study drug in a previous trial.
  • Any major illness within 30 days before the screening examination.
  • Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.

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): NCT02336503


Locations
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United States, California
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Florida
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
International Clinical Research
Sanford, Florida, United States, 32771
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Missouri
Saint Louis University Dermatology
Saint Louis, Missouri, United States, 63122
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, Texas
The Center for Skin Research
Houston, Texas, United States, 77056
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Brickell Biotech, Inc.
Investigators
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Study Director: Elizabeth Hussey, Pharm.D. Brickell Biotech, Inc.

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Responsible Party: Brickell Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02336503     History of Changes
Other Study ID Numbers: BBI-4000-CL-201
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases