Blue Light Therapy of C. Acnes

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300010
• Other study ID #: 2020-0018
• Secondary ID: A536110SMPH/ORTH
• Status: Completed
• Phase: Phase 4
• Start date: October 5, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: April 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• 5% Topical Benzoyl Peroxide Gel
Gel treatment used to treat acne

Device:
• Blue Light Therapy
Blue light therapy treatment for acne

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & 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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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