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

NCT02336503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2023-03-15

Study results available
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Summary

To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.

Conditions

  • Hyperhidrosis

Interventions

DRUG

BBI-4000 Gel, 5%

BBI-4000 Gel, 5%

DRUG

BBI-4000 Gel, 10%

BBI-4000 Gel, 10%

DRUG

BBI-4000 Gel, 15%

BBI-4000 Gel, 15%

DRUG

Vehicle

Placebo, BBI-4000 Gel, 0%

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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-10
Primary Completion
2015-11-05
Completion
2015-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02336503 on ClinicalTrials.gov