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

A Randomized, Double Blinded, Vehicle-Controlled Study to Evaluate the Safety and the Effect on Sweat Production of Topically Applied BBI-4000 in Subjects With Hyperhidrosis.

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: BBI-4000

Detailed Description

This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days.

Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology).

Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS).

Pharmacokinetic information will also be collected.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female subjects from 18 to 45 years of age in good general health.
• Primary axillary hyperhidrosis of at least 6 months duration.
• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
• Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
• Use of a medically appropriate contraceptive method.

Exclusion Criteria:

• Prior axillary use of botulinum toxin within 2 years of study entry.
• Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
• Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
• Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
• History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
• Known condition that may cause hyperhidrosis.
• Use of an investigational drug within 30 days prior to entry into this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Strength BBI-4000 and Vehicle	Drug: BBI-4000
Experimental: High Strength BBI-4000 and Vehicle	Drug: BBI-4000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in the gravimetrically measured sweat production from baseline	Week 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute change in the gravimetrically measured sweat production from baseline	Week 2
Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline.	Week 2
Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline	Week 2

Collaborators and Investigators

• Sponsor: Botanix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: BBI-4000-CL-101