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

NCT ID: NCT02058264

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperhidrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low Strength BBI-4000 and Vehicle

Group Type EXPERIMENTAL

BBI-4000

Intervention Type DRUG

High Strength BBI-4000 and Vehicle

Group Type EXPERIMENTAL

BBI-4000

Intervention Type DRUG

Interventions

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BBI-4000

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Botanix Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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Dominican Republic

Other Identifiers

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BBI-4000-CL-101

Identifier Type: -

Identifier Source: org_study_id