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Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (Cardigan II)

Primary Purpose

Axillary Hyperhidrosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sofpironium Bromide, 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

  • Cahaba Dermatology Skin & Health Center
  • Advanced Research Associates
  • Arkansas Research Trials
  • First OC Dermatology
  • CoDerm Research
  • Colorado Medical Research Center
  • CCD Research, PLLC
  • The GW Medical Faculty Associates
  • Driven Research, LLC
  • Florida Academic Dermatology Centers Research & Education, LLC
  • GSI Clinical Research
  • Cordova Research Institute
  • MOORE Clinical Research, Inc.
  • Advanced Medical Research PC
  • DeNova Research
  • Qualmedica Research, LLC
  • Heartland Research Asssociates - AMR Company
  • Delricht Research
  • DelRicht Research
  • Lupo Center for Aesthetic and General Dermatology
  • Etre, Cosmetic Dermatology and Laser Center
  • DermAssociates
  • Bay State Clinical Trials, Inc.
  • Michigan Center for Skin Care Research
  • Hamzavi Dermatology, Inc.
  • Saint Louis University, Department of Dermatology
  • Meridian Clinical Research, LLC
  • JDR Dermatology Research
  • Psoriasis Treatment Center of Central New Jersey
  • SkinSearch of Rochester
  • Dermatology, Laser and Vein Specialists of the Carolinas
  • Aventiv Research Inc.
  • Yardley Dermatology Associates, PC
  • Westlake Dermatology & Cosmetic Surgery
  • Bellaire Dermatology Associates
  • J&S Studies, Inc.
  • Modern Research Associates
  • University of Texas Health Science Center at Houston
  • Suzanne Bruce and Associates, P.A.
  • Dermatology Clinical Research Center of San Antonio
  • Center for Clinical Studies, LTD.LLP
  • Valley Dermatology and Skin Cancer Center

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 of axillary sweat production from baseline to end of study.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2019
Last Updated
December 23, 2022
Sponsor
Botanix Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03948646
Brief Title
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
Acronym
Cardigan II
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
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
August 13, 2021 (Actual)
Study Completion Date
August 13, 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
351 (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, 15%
Intervention Description
Active
Intervention Type
Drug
Intervention Name(s)
Vehicle
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 of axillary 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 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.
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
Cahaba Dermatology Skin & Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Advanced Research Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Arkansas Research Trials
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
CoDerm Research
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
CCD Research, PLLC
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
The GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Driven Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Florida Academic Dermatology Centers Research & Education, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
GSI Clinical Research
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Cordova Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
MOORE Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Qualmedica Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Heartland Research Asssociates - AMR Company
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Delricht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70116
Country
United States
Facility Name
Lupo Center for Aesthetic and General Dermatology
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Etre, Cosmetic Dermatology and Laser Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70130
Country
United States
Facility Name
DermAssociates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Hamzavi Dermatology, Inc.
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Saint Louis University, Department of Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
JDR Dermatology Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
SkinSearch of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatology, Laser and Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Aventiv Research Inc.
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Yardley Dermatology Associates, PC
City
Morrisville
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Westlake Dermatology & Cosmetic Surgery
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Suzanne Bruce and Associates, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Clinical Studies, LTD.LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Valley Dermatology and Skin Cancer Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
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-302)

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