Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis

NCT04636242 | Unknown Phase 3 FDA Drug

• 1 other identifier: SNAM19G.133
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

C. Acnes; Phototherapy; Postoperative Infection; Arthroscopic Rotator Cuff Repair; Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  13 days

Secondary Outcomes (1)

• Decrease Rate of Postoperative Infection

  3 months

Study Arms (2)

Group 1: Phototherapy Group

EXPERIMENTAL

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

Procedure: Skin Biopsy; Drug: 5 Aminolevulinic Acid + Phototherapy

Group 2: Control Group

ACTIVE COMPARATOR

patient will undergo standard of care surgery

Procedure: Skin Biopsy

Interventions

Skin Biopsy PROCEDURE

A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis

Group 1: Phototherapy Group; Group 2: Control Group

5 Aminolevulinic Acid + Phototherapy DRUG

5 aminolevulinic acid solution will be placed on the skin of the shoulder and the participant will receive Photodynamic therapy on the morning of surgery

Group 1: Phototherapy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women are being excluded because studies have shown that men have a higher bacterial burden of C. acnes than females. The male predisposition has been linked with the habitat of C. acnes being in the hair follicles and therefore the upper body of males would harbor more of the bacterium than females after shoulder surgery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All male patients (\>18) undergoing shoulder arthroscopy)

You may not qualify if:

• Female patients
• Patients with active acnes
• Patients who have taken antibiotics within a month of their surgery
• Subjects with psoriatic/eczematous lesions on the shoulder girdle
• Patients on anticoagulant therapy
• Patients who have a known allergy to any of the agents used in the study protocol

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Aminolevulinic Acid; Phototherapy

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 19, 2020
• Study Start: August 22, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

US (1)