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

NCT03024255 | Completed Phase 2 Results

• 1 other identifier: BBI-4000-CL-203
• Study Type: interventional
• Target: 227
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.

Conditions

Hyperhidrosis

Keywords

sweat gland disease; sweating; underarm

Outcome Measures

Primary Outcomes (2)

• Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy

  11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4). The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax

  overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.

• Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity

  Subjects reporting more than one adverse event are counted only once using the highest severity.

  Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)

Secondary Outcomes (1)

• Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population

  Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57

Study Arms (4)

BBI-4000 gel, 5%

EXPERIMENTAL

BBI-4000 gel, 5% applied once to each axilla daily

Drug: BBI-4000 gel, 5%

BBI-4000 gel, 10%

EXPERIMENTAL

BBI-4000 gel, 10% applied once to each axilla daily

Drug: BBI-4000 gel, 10%

BBI-4000 gel, 15%

EXPERIMENTAL

BBI-4000 gel, 15% applied once to each axilla daily

Drug: BBI-4000 gel, 15%

Vehicle

PLACEBO COMPARATOR

Placebo, applied once to each axilla daily

Drug: Vehicle (Placebo)

Interventions

BBI-4000 gel, 5% DRUG

BBI-4000 gel, 5% applied once to each axilla daily

Also known as: BBI-4000 Low Concentration

BBI-4000 gel, 5%

BBI-4000 gel, 10% DRUG

BBI-4000 gel, 10% applied once to each axilla daily

Also known as: BBI-4000 Medium Concentration

BBI-4000 gel, 10%

BBI-4000 gel, 15% DRUG

BBI-4000 gel, 15% applied once to each axilla daily

Also known as: BBI-4000 High Concentration

BBI-4000 gel, 15%

Vehicle (Placebo) DRUG

Placebo, applied once to each axilla daily

Also known as: Control

Vehicle

Eligibility Criteria

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

You may qualify if:

• Male or female subject ≥ 18 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, (c) HDSS of 3 or 4 and (d) 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.

You may not qualify if:

• 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 potent inhibitors of cytochrome P450 CYP3A and CYP2D6.
• Use of any cholinergic drug (e.g. bethanechol) within 30 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.
• History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

MeSH Terms

Conditions

Hyperhidrosis; Sweat Gland Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anthony Robinson, MS CRNP
• 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 6, 2017
• First Posted: January 18, 2017
• Study Start: December 22, 2016
• Primary Completion: September 19, 2017
• Study Completion: September 19, 2017
• Last Updated: May 16, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share