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

NCT02058264 | Completed Phase 1

• 1 other identifier: BBI-4000-CL-101
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• Percent change in the gravimetrically measured sweat production from baseline

  Week 2

Secondary Outcomes (3)

• 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

Study Arms (2)

Low Strength BBI-4000 and Vehicle

EXPERIMENTAL

Drug: BBI-4000

High Strength BBI-4000 and Vehicle

EXPERIMENTAL

Drug: BBI-4000

Interventions

BBI-4000 DRUG

High Strength BBI-4000 and Vehicle; Low Strength BBI-4000 and Vehicle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 16, 2022

Record last verified: 2022-12