A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses

What Was Tested

The trial (phase 2) is built around Methylene blue (non-peptide stack partner).

The study includes two arms: (1) standard of care breast abscess drainage and (2) MB-PDT plus standard of care breast abscess drainage.

The primary endpoint is time to resolution of clinical symptoms.

It had two arms (groups): MB-PDT + standard of care (experimental) and Standard of care (other).

Each subject in this arm will receive standard of care breast abscess drainage, methylene blue, lipid emulsion, and laser illumination.

Each subject in this arm will receive standard of care abscess drainage.

The registry classes the interventions as device, drug and procedure.

More on the Plan

Breast abscesses consist of a localized, walled-off collection of infected fluid within the breast, with symptoms including breast pain and inflammation, as well as nipple discharge, fever, chills, and nausea.

If left untreated, breast abscesses can result in serious complications, including fistula formation and sepsis.

The standard of care therefore involves draining the purulent fluid, generally under ultrasound guidance, and systemic antibiotic administration.

Although this drainage procedure is typically technically successful, reported recurrence rates vary widely.

Who Took Part

50 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults 18 years or older. Clinical signs of breast abscess, including pain, redness, and/or heat of the breast. Approval by the primary care team to pursue PDT and discuss enrollment with the patient.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: allergy to contrast media, narcotics, sedatives, atropine or eggs; necrotic tissue that requires surgical debridement; severely compromised cardiopulmonary function or hemodynamic instability.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2027-07 with completion listed for 2032-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to resolution of clinical symptoms (time frame: Day 1 post-intervention until resolution of symptoms).

It also tracked 1 secondary outcome, for example Abscess volume on ultrasound tomography.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 50 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.