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A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar 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. Identifier: NCT02682238
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : July 20, 2018
Information provided by (Responsible Party):
Brickell Biotech, Inc.

Brief Summary:
To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: BBI-4000, 15% Other: Vehicle gel Phase 2

Detailed Description:

This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar Hyperhidrosis.

Participating subjects will apply either BBI-4000 15% or vehicle gel topically to the palms of both hands once daily for 4 consecutive weeks. The 4 week treatment period will be followed by a 2 week follow-up period.

Safety and tolerability will be assessed through collection of vital signs, adverse events, assessment of local skin responses, ECG, UPT and blood sampling.

Efficacy will be assessed through gravimetric sweat assessments as well as through the Hyperhidrosis Disease Severity Scale (HDSS).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 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 Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects With Palmar Hyperhidrosis
Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: BBI-4000, 15%
15% BBI-4000 (sofpironium bromide) topical gel
Drug: BBI-4000, 15%
Placebo Comparator: Vehicle
Vehicle (placebo) gel
Other: Vehicle gel
Other Name: Placebo gel

Primary Outcome Measures :
  1. Safety assessed through AEs, blood laboratory evaluations, UPTs, ECGs, vital signs and local tolerability assessments. [ Time Frame: Day 1 - Week 4 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving a 1-grade & 2-grade improvement in HDSS from baseline. [ Time Frame: Week 4 ]
  2. Absolute and percent change in the gravimetrically measured sweat production from baseline. [ Time Frame: Week 4 ]
  3. Proportion of subjects achieving a minimum of 50% reduction in sweat from baseline [ Time Frame: Week 4 ]

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

Inclusion Criteria:

  • Diagnosis of primary palmar hyperhidrosis
  • HDSS of 3 or 4 at baseline
  • Gravimetric test at baseline indicating at least 100 mg of sweat production at rest in each palm and a sum of at least 250 mg in both palms, in 5 minutes (room temperature)
  • Symptoms of at least 6 months' duration
  • 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 of the palms, other than hyperhidrosis
  • Prior use of any prohibited medication(s) or procedure(s) within specified timeframe for the treatment of palmar hyperhidrosis, including:

    1. Botulinum toxin to the palmar area within 9 months of baseline visit
    2. Iontophoresis within 30 days of baseline visit
    3. Palmar thermolysis, sympathectomy or surgical procedures of the palmar area any time in the past
    4. Serotonergic agonist within 30 days of baseline visit
    5. Any topical prescription treatment for hyperhidrosis within 30 days of baseline visit
    6. Any over-the-counter topical antiperspirant/deodorant within 7 days of baseline visit
  • Use of anticholinergic agents within 30 days of baseline visit
  • Any oral or topical homeopathic or herbal treatment within 30 days of baseline visit
  • Use of any cholinergic drug within 30 days of baseline visit
  • Use of any anti-anxiety and/or anti-depressant, amphetamine products or drugs with known anticholinergic side effects
  • Hyperhidrosis secondary to any known cause
  • Subjects with history of unstable type 1 or type 2 diabetes mellitus or thyroid disease, history of renal impairment, hepatic impairment, 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.
  • Any major illness within 30 days before the screening examination.

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 identifier (NCT number): NCT02682238

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United States, California
TCR Medical Corporation
San Diego, California, United States, 92123
United States, Florida
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
United States, Missouri
Saint Louis University Dermatology
Saint Louis, Missouri, United States, 63122
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Brickell Biotech, Inc.
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Responsible Party: Brickell Biotech, Inc. Identifier: NCT02682238    
Other Study ID Numbers: BBI-4000-CL-202
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases