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

NCT03024255 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2023-05-16

Study results available
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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

Interventions

DRUG

BBI-4000 gel, 5%

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

DRUG

BBI-4000 gel, 10%

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

DRUG

BBI-4000 gel, 15%

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

DRUG

Vehicle (Placebo)

Placebo, applied once to each axilla daily

Sponsors & Collaborators

  • Botanix Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Patricia Walker, MD PhD · Botanix Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2017-09-19
Completion
2017-09-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03024255 on ClinicalTrials.gov