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A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea

NCT03590366 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-09-16

Study results available
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Summary

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.

Conditions

  • Rosacea

Interventions

BIOLOGICAL

B244

B244 Suspension

BIOLOGICAL

Vehicle

Vehicle suspension

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • AOBiome LLC

    lead INDUSTRY

Principal Investigators

  • Judith Ng-Cashin, MD · Chief Medical Officer

  • Spiros Jamas, ScD · AOBiome Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2019-02-11
Completion
2019-03-05
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 NCT03590366 on ClinicalTrials.gov