A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyper… (NCT02058264) | Clinical Trial Compass
CompletedPhase 1
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
18 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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.
What they're measuring
1
Percent change in the gravimetrically measured sweat production from baseline