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Completed

NCT Number: NCT04300010

Blue Light Therapy of C. Acnes

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5% Topical Benzoyl Peroxide Gel

Drug

Gel treatment used to treat acne

Blue Light Therapy

Device

Blue light therapy treatment for acne

Primary outcomes

  1. Number of Participants With C. Acnes Bacterium Culture After Treatment

    Time frame: up to 2 days

    Swab will be taken from skin and cultured for approximately 7 days to determine bacteria growth. This result is for the null condition following treatment with either blue light, blue light plus benzoyl peroxide or just benzoyl peroxide but before additional preparation with chlorhexidine.

  2. Median Colony Forming Units (CFU) After Treatment

    Time frame: up to 2 days

    Quantitative culture analysis between treatment groups after treatment to the shoulder but before chlorhexidine preparation (null condition).

  3. Percentage of Participants in Each Group With Positive C. Acnes Cultures

    Time frame: up to 2 days

    Comparison of positive Cutibacterium acnes cultures as a binary (yes/no) outcome between treatment arm and control arm following chlorhexidine (CHX) prep. Reported is the percentage of people in each group that had Cutibacterium acnes growth.

  4. Median Colony Forming Units Per mL Treatment vs Control

    Time frame: up to 2 days

    Samples taken from treatment arm and control arm after chlorhexidine (CHX) preparation on both sides.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Efficacy of Blue Light Therapy in Reducing Cutibacterium Acnes Bioburden at the Deltopectoral Interval

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2020
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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