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

NCT02336503 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BBI-4000-CL-201
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 12

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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4

  Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities

  Baseline through Week 4 (Day 29)

Secondary Outcomes (3)

• Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4

  Baseline through Week 4 (Day 29)

• Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)

  Baseline through Week 4 (Day 29)

• Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4

  Baseline through Week 4 (Day 29)

Study Arms (4)

BBI-4000 Gel, 5%

EXPERIMENTAL

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

Drug: BBI-4000 Gel, 5%

BBI-4000 Gel, 10%

EXPERIMENTAL

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

Drug: BBI-4000 Gel, 10%

BBI-4000 Gel, 15%

EXPERIMENTAL

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

Drug: BBI-4000 Gel, 15%

Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

BBI-4000 Gel, 5% DRUG

BBI-4000 Gel, 5%

Also known as: BBI-4000 Low Dose

BBI-4000 Gel, 5%

BBI-4000 Gel, 10% DRUG

BBI-4000 Gel, 10%

Also known as: BBI-4000 Middle Dose

BBI-4000 Gel, 10%

BBI-4000 Gel, 15% DRUG

BBI-4000 Gel, 15%

Also known as: BBI-4000 High Dose

BBI-4000 Gel, 15%

Vehicle DRUG

Placebo, BBI-4000 Gel, 0%

Also known as: Placebo

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Botulinum toxin to the axillary area within 1 year of the baseline visit.
• Axillary iontophoresis within 12 weeks of baseline visit.
• 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.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (12)

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

International Clinical Research

Sanford, Florida, 32771, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Saint Louis University Dermatology

St Louis, Missouri, 63122, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vice President, Head of Development
• Organization: Botanix Pharmaceuticals

trials@botanixpharma.com

+1 (445) 300-3403

Study Officials

• Patricia Walker, MD PhD

  Botanix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: March 10, 2015
• Primary Completion: November 5, 2015
• Study Completion: November 5, 2015
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2022-12

Locations

US (12)