Blue Light Therapy of C. Acnes

NCT04300010 | Completed Phase 4 Results FDA Drug FDA Device

• 4 other identifiers: 2020-0018A536110SMPH/ORTHO&REHAB/ORTHOProtocol Version 9/14/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (4)

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

  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.

  up to 2 days

• Median Colony Forming Units (CFU) After Treatment

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

  up to 2 days

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

  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.

  up to 2 days

• Median Colony Forming Units Per mL Treatment vs Control

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

  up to 2 days

Study Arms (3)

Blue Light Therapy

ACTIVE COMPARATOR

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

5% Topical Benzoyl Peroxide Gel

ACTIVE COMPARATOR

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

Light and Gel

ACTIVE COMPARATOR

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; Device: Blue Light Therapy

Interventions

5% Topical Benzoyl Peroxide Gel DRUG

Gel treatment used to treat acne

5% Topical Benzoyl Peroxide Gel; Light and Gel

Blue Light Therapy DEVICE

Blue light therapy treatment for acne

Blue Light Therapy; Light and Gel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 34478863 RESULT

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Eric Cotter, MD
• Organization: UW School of Medicine and Public Health

ecotter@uwhealth.org

920.362.9221

Study Officials

• Brian F Grogan, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: October 5, 2020
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)