Phase 4
N=120
Blue Light Therapy of C. Acnes
Acne
Bottom Line
View on ClinicalTrials.gov: NCT04300010 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With C. Acnes Bacterium Culture After Treatment — 20; 20; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 5% Topical Benzoyl Peroxide Gel (Drug); Blue Light Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With C. Acnes Bacterium Culture After Treatment |
20; 20; 16 | — |
| PRIMARY Median Colony Forming Units (CFU) After Treatment |
304000; 28500; 12100 | — |
| PRIMARY Percentage of Participants in Each Group With Positive C. Acnes Cultures |
90.0; 15.0; 40.0; 80.0; 85.0; 70.0 | — |
| PRIMARY Median Colony Forming Units Per mL Treatment vs Control |
50000; 2000; 2000; 108000; 41500; 20000 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04300010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.