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Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (Cardigan I)

Primary Purpose

Axillary Hyperhidrosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sofpironium Bromide Gel, 15%
Vehicle
Sponsored by
Botanix Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axillary Hyperhidrosis

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subject ≥ 9 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 and (c) 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 any cholinergic drug (e.g. bethanechol) within 28 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.

Sites / Locations

  • Total Skin and Beauty Dermatology Center, P.C.
  • Investigate MD, LLC
  • Northwest Arkansas Clinical Trials Center
  • California Dermatology & Clinical Research Institute
  • Dermatology Research Associates
  • Therapeutics Clinical Research
  • Clinical Science Institute
  • AboutSkin Research, LLC
  • Center for Clinical & Cosmetic Research
  • Skin Care Research, LLC
  • Skin Research Institute
  • Finlay Medical Research
  • Aby's New Generation Research
  • Baumann Cosmetic and Research Institute
  • International Dermatology Research, Inc.
  • My Community Research Center, Inc.
  • Tory Sullivan, MD PA
  • Research Institute of the Southeast
  • Dawes Fretzin Research Group
  • Maryland Laser Skin and Vein
  • Lawrence J Green, MD LLC
  • SkinCare Physicians
  • Grekin Skin Institute
  • Minnesota Clinical Study Center
  • MediSearch Clinical Trials
  • Skin Specialists, P.C.
  • Hassman Research Institute
  • DermResearch Center of New York, Inc.
  • PMG Research of Cary
  • Haber Dermatology and Cosmetic Surgery, Inc.
  • Oregon Dermatology & Research Center
  • Clinical Research Center of the Carolinas
  • Tennessee Clinical Research Center
  • DermResearch, Inc.
  • Austin Institute for Clinical Research, Inc.
  • Progressive Clinical Research
  • Texas Dermatology and Laser Specialists
  • Virginia Clinical Research, Inc.
  • Dermatology Associates of Seattle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Vehicle

Arm Description

Sofpironium bromide, 15% gel, once per day

Vehicle gel, once per day

Outcomes

Primary Outcome Measures

The number of participants with treatment emergent adverse events
Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe
Change in Hyperhidrosis Disease Severity Measure-Axillary score
Change in score from baseline to end of treatment of an 11 question patient reported outcome assessment, each question has a 5 point response (range 0 [better] - 4 [worse]).
Gravimetric sweat production
Change in the measured weight (mg) of axillary (right+left axillae) sweat production from baseline to end of study.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2019
Last Updated
April 27, 2023
Sponsor
Botanix Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03836287
Brief Title
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Acronym
Cardigan I
Official Title
A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Botanix Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
Detailed Description
This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel 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. A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle. Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points. The study will be comprised of a total of 13 scheduled visits to take place over approximately 11 to 15 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Hyperhidrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Sofpironium bromide, 15% gel, once per day
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle gel, once per day
Intervention Type
Drug
Intervention Name(s)
Sofpironium Bromide Gel, 15%
Other Intervention Name(s)
BBI-4000 Gel, 15%
Intervention Description
Active
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
BBI-4000 Gel, 0%; Placebo
Intervention Description
Vehicle gel
Primary Outcome Measure Information:
Title
The number of participants with treatment emergent adverse events
Description
Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe
Time Frame
Through study completion (6 weeks).
Title
Change in Hyperhidrosis Disease Severity Measure-Axillary score
Description
Change in score from baseline to end of treatment of an 11 question patient reported outcome assessment, each question has a 5 point response (range 0 [better] - 4 [worse]).
Time Frame
6 weeks
Title
Gravimetric sweat production
Description
Change in the measured weight (mg) of axillary (right+left axillae) sweat production from baseline to end of study.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject ≥ 9 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 and (c) a minimum GSP of 50 mg in 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(e). 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 any cholinergic drug (e.g. bethanechol) within 28 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Walker, MD PhD
Organizational Affiliation
Botanix Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigate MD, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Northwest Arkansas Clinical Trials Center
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92007
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
AboutSkin Research, LLC
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Center for Clinical & Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Skin Care Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Skin Research Institute
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Finlay Medical Research
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Aby's New Generation Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Baumann Cosmetic and Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
My Community Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Tory Sullivan, MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Research Institute of the Southeast
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Dawes Fretzin Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Maryland Laser Skin and Vein
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
Lawrence J Green, MD LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
SkinCare Physicians
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Skin Specialists, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
DermResearch Center of New York, Inc.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
PMG Research of Cary
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Haber Dermatology and Cosmetic Surgery, Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Associates of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)

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