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

NCT ID: NCT02336503

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-10
• Study Completion Date: 2015-11-05

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.

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.

Conditions

Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BBI-4000 Gel, 5%

Low concentration of BBI-4000; BBI-4000 Gel, 5%

Group Type: EXPERIMENTAL

BBI-4000 Gel, 5%

Intervention Type: DRUG

BBI-4000 Gel, 5%

BBI-4000 Gel, 10%

Middle concentration of BBI-4000; BBI-4000 Gel, 10%

Group Type: EXPERIMENTAL

BBI-4000 Gel, 10%

Intervention Type: DRUG

BBI-4000 Gel, 10%

BBI-4000 Gel, 15%

High concentration of BBI-4000; BBI-4000 Gel, 15%

Group Type: EXPERIMENTAL

BBI-4000 Gel, 15%

Intervention Type: DRUG

BBI-4000 Gel, 15%

Vehicle

Vehicle (placebo); BBI-4000 Gel, 0%

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Placebo, BBI-4000 Gel, 0%

Interventions

BBI-4000 Gel, 5%

BBI-4000 Gel, 5%

Intervention Type: DRUG

BBI-4000 Gel, 10%

BBI-4000 Gel, 10%

Intervention Type: DRUG

BBI-4000 Gel, 15%

BBI-4000 Gel, 15%

Intervention Type: DRUG

Vehicle

Placebo, BBI-4000 Gel, 0%

Intervention Type: DRUG

Other Intervention Names

BBI-4000 Low Dose; BBI-4000 Middle Dose; BBI-4000 High Dose; Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Botanix Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Walker, MD PhD

Role: STUDY_DIRECTOR

Botanix Pharmaceuticals

Locations

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

International Clinical Research

Sanford, Florida, United States

Shideler Clinical Research Center

Carmel, Indiana, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Saint Louis University Dermatology

St Louis, Missouri, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

The Center for Skin Research

Houston, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

BBI-4000-CL-201

Identifier Type: -

Identifier Source: org_study_id