Clinical trial NCT04300010: Blue Light Therapy of C. Acnes
Official title: Efficacy of Blue Light Therapy in Reducing Cutibacterium Acnes Bioburden at the Deltopectoral Interval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposal aims to investigate a novel light-based treatment to reduce morbidity in shoulder surgical patients. This has potential to improve outcomes and reduce health care utilization associated with infectious complications of shoulder arthroplasty. Participants will be healthy male volunteers at least 18 years of age. They will be on study for approximately 2 days.

Detailed description: Participants will have two study visits (consent plus treatment and swabs for culture). These visits will be conducted at the main UW Hospital, UW Health at the American Center, or UW Health at 1 S. Park. All visits will be conducted in reserved conference rooms at each location.

Once a subject is determined to be eligible and has consented to the study, they will be randomized into one of three treatment groups. Study team has blank envelopes that contain one of the three treatment groups enclosed. After a subject consents to the study, the study team will randomly draw an envelope to assign a treatment arm.

Arm 1. One group will receive 5% topical benzoyl peroxide gel plus 2% chlorhexidine gluconate with 70% isopropyl alcohol

Arm 2. One group will receive blue light therapy plus 2% chlorhexidine gluconate with 70% isopropyl alcohol

Arm 3. One group will receive both of the above treatments

All participants will have their contralateral shoulder serve as the control (2% chlorhexidine gluconate with 70% isopropyl alcohol only). All treatment will be provided by the study team. Participants will also be asked to complete a research intake form.

If C. acnes does grow for a tissue culture, Investigators plan to bank a colony of the bacterium for potential use in a future study. There will be no added risk to research subjects as no additional cultures will be taken and samples will be completely anonymized. The banked samples will simply be a colony of growth from the culture media for storage for possible future use. Samples will be banked for 5 years from the date of study completion after which time the samples will be destroyed.

Eligibility criteria: Inclusion Criteria:

* Healthy male
* 18 years or older

Exclusion Criteria:

* Allergy to benzoyl peroxide or chlorhexidine
* \<18 years of age
* Previous history of shoulder infections
* Antibiotics taken within one month of research visit
* Immunocompromised state
* Active cancer
* Diabetic
* Skin lesions or abrasions over the deltopectoral interval
* Topical corticosteroid treatment to either shoulder or or systemic corticosteroid treatment within 2 weeks of research visit
* Topical benzoyl peroxide treatment to either shoulder within 2 weeks of research visit
* Blue light therapy treatment to either shoulder within 2 weeks of research visit
* Prior incision over the deltopectoral interval of either shoulder
* Contraindication to blue light treatment

Primary outcomes:
measure: Number of Participants With C. Acnes Bacterium Culture After Treatment
timeFrame: up to 2 days
measure: Median Colony Forming Units (CFU) After Treatment
timeFrame: up to 2 days
measure: Percentage of Participants in Each Group With Positive C. Acnes Cultures
timeFrame: up to 2 days
measure: Median Colony Forming Units Per mL Treatment vs Control
timeFrame: up to 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Brian F Grogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cotter EJ, Cotter LM, Franczek EB, Godfrey JJ, Hetzel SJ, Safdar N, Dai T, Arkin L, Grogan BF. Efficacy of combinational therapy using blue light and benzoyl peroxide in reducing Cutibacterium acnes bioburden at the deltopectoral interval: a randomized controlled trial. J Shoulder Elbow Surg. 2021 Dec;30(12):2671-2681. doi: 10.1016/j.jse.2021.08.008. Epub 2021 Aug 31.