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Blue Light Therapy of C. Acnes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04300010
Recruitment Status : Completed
First Posted : March 9, 2020
Results First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Acne Drug: 5% Topical Benzoyl Peroxide Gel Device: Blue Light Therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Blue Light Therapy in Reducing Cutibacterium Acnes Bioburden at the Deltopectoral Interval
Actual Study Start Date : October 5, 2020
Actual Primary Completion Date : January 22, 2021
Actual Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: Blue Light Therapy
FDA cleared blue light product, Omniluxblue (Globalmed Technologies, Glen Elen, CA), which emits a 415 nm blue light irradiance of 40mW/cm2. Following the application of blue light protective eyewear, the blue light therapy device will be centered over the deltopectoral interval according to device standardized use instructions and a 23-minute treatment will be administered to dry skin. As was done in the topical BPO group, following treatment, a skin swab culture of the treatment shoulder will be taken, then both the treatment shoulder and control shoulder will be sterilely prepped with 2% chlorhexidine gluconate solution with 70% isopropyl alcohol and allowed to dry for 3 minutes. Following chlorhexidine preparation, a single set of cultures will be obtained from each shoulder. Participants and research personnel conducting the blue light treatments will be wearing medical grade blue light protective glasses for safety.
Device: Blue Light Therapy
Blue light therapy treatment for acne

Active Comparator: 5% Topical Benzoyl Peroxide Gel
A pea-sized amount, ~0.5 grams, will be applied to a 10cm strip over the deltopectoral interval beginning the morning 48 hours prior to schedule research visit to obtain cultures. The benzoyl peroxide will be applied on dry skin after a shower. The gel will be applied once in the morning and once in the evening for two consecutive days as well as the morning of the scheduled research visit. Following treatment, a skin swab culture of the treatment shoulder will be taken, both the treatment shoulder and control shoulder will be sterilely prepped with 2% chlorhexidine gluconate solution with 70% isopropyl alcohol and allowed to dry for 3 minutes. Following chlorhexidine preparation, a single set of cultures will be obtained from each shoulder.
Drug: 5% Topical Benzoyl Peroxide Gel
Gel treatment used to treat acne

Active Comparator: Light and Gel
Prior to treatment, a skin swab culture will be taken, 5% topical benzoyl peroxide treatment will be performed on dry skin immediately after a shower as described in the above paragraph. Again, five total treatments will be performed prior to research visit. On the day of the research visit, the blue light therapy protocol described above will be performed exactly the same followed by culture obtainment.
Drug: 5% Topical Benzoyl Peroxide Gel
Gel treatment used to treat acne

Device: Blue Light Therapy
Blue light therapy treatment for acne




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males have a higher incidence of C. Acnes. Inclusion criteria includes males 18 years of age and older, as this is the gender and age group most likely to have C. Acnes.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300010


Locations
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United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Brian F Grogan, MD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04300010    
Other Study ID Numbers: 2020-0018
A536110 ( Other Identifier: UW Madison )
SMPH/ORTHO&REHAB/ORTHO ( Other Identifier: UW Madison )
Protocol Version 9/14/2020 ( Other Identifier: UW Madison )
First Posted: March 9, 2020    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: May 10, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents