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Photosensitizer

Methylene Blue Photodynamic Therapy for Abscess

Phase 1
Waitlist Available
Led By Ashwani K Sharma, MD
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 up to 14 days post-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 ~within 1 hour of the study procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 hour of the study 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
Laser illumination, 30 minutes
2014
Completed Phase 1
~30
Methylene Blue
2021
Completed Phase 4
~1390
Insertion of optical fiber
2014
Completed Phase 1
~30
Laser illumination, 20 minutes
2014
Completed Phase 1
~30
Optical spectroscopy measurement
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, 25 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
833 Previous Clinical Trials
518,123 Total Patients Enrolled
1 Trials studying Abscess
60 Patients Enrolled for Abscess
Laurie Christensen, BSStudy DirectorUniversity of Rochester
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Abscess
60 Patients Enrolled for Abscess
Ashwani K Sharma, MDPrincipal InvestigatorUniversity of Rochester
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Abscess
60 Patients Enrolled for Abscess

Media Library

Methylene Blue (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT02240498 — Phase 1
Abscess Research Study Groups: MB-PDT, 15 min illumination, MB-PDT, 20 min illumination, MB-PDT, 25 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the results of previous experiments involving MB-PDT with a thirty minute light exposure?

"Currently, 22 MB-PDT, 30 min illumination trials are ongoing with 3 of them being in the final stage. Moreover, 36 different clinical sites across the United States have opened their doors to participating patients for this specific trial. Among these locations is New Haven Connecticut."

Answered by AI

What is the scope of patient recruitment for this research?

"Verbally affirmed, this clinical trial is open for recruitment as per the information on clinicaltrials.gov. It was first introduced on September 1st 2014 and most recently amended on March 23rd 2022. The research initiative requires 21 participants from one centre of study."

Answered by AI

How is MB-PDT, 30 min illumination typically implemented for treatment?

"MB-PDT with a 30 minute illumination time is commonly used to address urethritis, however it has also found success in combatting issues such as nephritis, parenteral nutrition, total and inflammation."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned thirty minutes of MB-PDT for therapeutic use?

"Although there is some evidence suggesting efficacy, the limited amount of data surrounding MB-PDT safety gives it a rating of 1 on our scale."

Answered by AI

Is there still an opportunity to join this research endeavor?

"According to records hosted on clinicaltrials.gov, enrollment for this medical research is ongoing. The trial was initiated on September 1st 2014 and last modified on March 23rd 2022."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of Rochester Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~2 spots leftby Mar 2025