← Back to Search

Photosensitizer

Group 1: Phototherapy Group for Phototherapy

Phase 3
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All male patients (>18) undergoing shoulder arthroscopy)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of Cutibacterium acnes (C. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections. -Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. Adding ALA to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. When these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. This therapy does not cause any damage to the mammalian cells, which makes PDT safe for human skin treatment.

Eligible Conditions
  • Phototherapy
  • Arthroscopic Rotator Cuff Repair
  • Infections
  • Acne
  • Shoulder Surgery

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the number of patients who have microbiological results positive for the bacteria C. acnes after treatment with 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) versus those who were not.
Secondary outcome measures
Decrease Rate of Postoperative Infection

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: Phototherapy GroupExperimental Treatment2 Interventions
patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered
Group II: Group 2: Control GroupActive Control1 Intervention
patient will undergo standard of care surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skin Biopsy
2015
Completed Phase 4
~630

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,458 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~21 spots leftby Apr 2025