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Photosensitizer

Methylene Blue Photodynamic Therapy for Abscess

Phase 1
Waitlist Available
Led By Timothy M Baran, PhD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one hour of the trial procedure
Awards & highlights

Study Summary

This trial is testing a new way to treat deep tissue abscesses using light therapy along with a medicine called methylene blue. The goal is to see if this is a safe and effective treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disruption of the abscess wall and damage to surrounding tissue
Evidence of fat embolism
Methylene blue escape during procedure with evidence of adverse reaction
+4 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: MB-PDT, 5 min illuminationExperimental Treatment4 Interventions
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, and laser illumination, 5 minutes.
Group II: MB-PDT, 30 min illuminationExperimental Treatment5 Interventions
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 30 minutes.
Group III: MB-PDT, 25 min illuminationExperimental Treatment5 Interventions
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 25 minutes.
Group IV: MB-PDT, 20 min illuminationExperimental Treatment5 Interventions
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 20 minutes.
Group V: MB-PDT, 15 min illuminationExperimental Treatment5 Interventions
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 15 minutes.
Group VI: MB-PDT, 10 min illuminationExperimental Treatment5 Interventions
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 10 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optical spectroscopy measurement
2014
Completed Phase 1
~30
Insertion of optical fiber
2014
Completed Phase 1
~30
Methylene Blue
2021
Completed Phase 4
~1390
Laser illumination, 20 minutes
2014
Completed Phase 1
~30
Laser illumination, 30 minutes
2014
Completed Phase 1
~30
Laser illumination, 25 minutes
2014
Completed Phase 1
~30
Laser illumination, 5 minutes
2014
Completed Phase 1
~30
20% I.V. Fat Emulsion
2014
Completed Phase 1
~30
Laser illumination, 15 minutes
2014
Completed Phase 1
~30
Laser illumination, 10 minutes
2014
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
845 Previous Clinical Trials
534,996 Total Patients Enrolled
1 Trials studying Abscess
90 Patients Enrolled for Abscess
Laurie Christensen, BSStudy DirectorUniversity of Rochester
1 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Abscess
90 Patients Enrolled for Abscess
Timothy M Baran, PhDPrincipal InvestigatorUniversity of Rochester
1 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Abscess
90 Patients Enrolled for Abscess

Media Library

Methylene Blue (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT02240498 — Phase 1
Abscess Research Study Groups: MB-PDT, 25 min illumination, MB-PDT, 15 min illumination, MB-PDT, 20 min illumination, MB-PDT, 30 min illumination, MB-PDT, 5 min illumination, MB-PDT, 10 min illumination
Abscess Clinical Trial 2023: Methylene Blue Highlights & Side Effects. Trial Name: NCT02240498 — Phase 1
Methylene Blue (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02240498 — Phase 1
~2 spots leftby May 2025
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