Blue Light Therapy of C. Acnes

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    60
  • sponsor
    University of Wisconsin, Madison
Updated on 1 March 2021
benzoyl peroxide

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.

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.

Details
Condition Acne Vulgaris, Acne, acnes
Treatment Blue light therapy, 5% Topical Benzoyl Peroxide Gel
Clinical Study IdentifierNCT04300010
SponsorUniversity of Wisconsin, Madison
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy male
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 cortiosteroid treatment to either shoulder or or systemic corticosteroid treatment within 2 weeks of research visit
Prior incision over the deltopectoral interval of either shoulder
Topical benzoyl peroxide treatment to either shoulder within 2 weeks of research visit
Contraindication to blue light treatment
Blue light therapy treatment to either shoulder within 2 weeks of research visit
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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