Acne
Conditions
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.
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.
Interventions
DRUG5% Topical Benzoyl Peroxide Gel
Gel treatment used to treat acne
DEVICEBlue Light Therapy
Blue light therapy treatment for acne
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With C. Acnes Bacterium Culture After Treatment | 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. |
| Median Colony Forming Units (CFU) After Treatment | up to 2 days | Quantitative culture analysis between treatment groups after treatment to the shoulder but before chlorhexidine preparation (null condition). |
| Percentage of Participants in Each Group With Positive C. Acnes Cultures | 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. |
| Median Colony Forming Units Per mL Treatment vs Control | up to 2 days | Samples taken from treatment arm and control arm after chlorhexidine (CHX) preparation on both sides. |
Countries
United States
Participant flow
Recruitment details
Volunteers were recruited through fliers around the study institution's facilities, through Clinicaltrials.gov, and informational emails to clinical staff listservs at the study University of Wisconsin - Madison. Participants were enrolled from 10/5/20 through 1/22/21.
Participants by arm
| Arm | Count |
|---|---|
| Blue Light Therapy Blue Light Therapy: Blue light therapy treatment for acne | 20 |
| 5% Topical Benzoyl Peroxide Gel 5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne | 20 |
| Light and Gel 5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
Blue Light Therapy: Blue light therapy treatment for acne | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| Age, Continuous | 26.70 years STANDARD_DEVIATION 2.99 | 26.80 years STANDARD_DEVIATION 3.62 | 25.90 years STANDARD_DEVIATION 2.97 | 26.47 years STANDARD_DEVIATION 2.97 |
| Asthma | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Autoimmune Condition | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Body Mass Index (BMI) | 24.60 kg/m^2 STANDARD_DEVIATION 3.49 | 24.56 kg/m^2 STANDARD_DEVIATION 2.3 | 24.63 kg/m^2 STANDARD_DEVIATION 3.92 | 24.60 kg/m^2 STANDARD_DEVIATION 3.67 |
| Consume Alcohol | 18 Participants | 16 Participants | 19 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 19 Participants | 18 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Infection Requiring Intravenous Antibiotics | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Number of Alcohol Drinks per Week | 2.05 drinks per week STANDARD_DEVIATION 1.78 | 2.15 drinks per week STANDARD_DEVIATION 1.91 | 2.58 drinks per week STANDARD_DEVIATION 2.01 | 2.26 drinks per week STANDARD_DEVIATION 1.89 |
| Occupation Other Healthcare Professional | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Occupation Resident | 5 Participants | 7 Participants | 3 Participants | 15 Participants |
| Occupation Student | 15 Participants | 13 Participants | 16 Participants | 44 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 13 Participants | 14 Participants | 15 Participants | 42 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 60 |
| other Total, other adverse events | 6 / 20 | 6 / 20 | 6 / 20 | 2 / 60 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 60 |
Outcome results
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).
Time frame: up to 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blue Light Therapy | Median Colony Forming Units (CFU) After Treatment | 304000 CFU/mL |
| 5% Topical Benzoyl Peroxide Gel | Median Colony Forming Units (CFU) After Treatment | 28500 CFU/mL |
| Light and Gel | Median Colony Forming Units (CFU) After Treatment | 12100 CFU/mL |
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.
Time frame: up to 2 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Blue Light Therapy | Median Colony Forming Units Per mL Treatment vs Control | Treatment plus CHX Arm | 50000 CFU/mL |
| Blue Light Therapy | Median Colony Forming Units Per mL Treatment vs Control | Control Arm after CHX | 108000 CFU/mL |
| 5% Topical Benzoyl Peroxide Gel | Median Colony Forming Units Per mL Treatment vs Control | Treatment plus CHX Arm | 2000 CFU/mL |
| 5% Topical Benzoyl Peroxide Gel | Median Colony Forming Units Per mL Treatment vs Control | Control Arm after CHX | 41500 CFU/mL |
| Light and Gel | Median Colony Forming Units Per mL Treatment vs Control | Treatment plus CHX Arm | 2000 CFU/mL |
| Light and Gel | Median Colony Forming Units Per mL Treatment vs Control | Control Arm after CHX | 20000 CFU/mL |
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.
Time frame: up to 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blue Light Therapy | Number of Participants With C. Acnes Bacterium Culture After Treatment | 20 Participants |
| 5% Topical Benzoyl Peroxide Gel | Number of Participants With C. Acnes Bacterium Culture After Treatment | 20 Participants |
| Light and Gel | Number of Participants With C. Acnes Bacterium Culture After Treatment | 16 Participants |
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.
Time frame: up to 2 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Blue Light Therapy | Percentage of Participants in Each Group With Positive C. Acnes Cultures | Treatment plus CHX Arm | 90.0 percent |
| Blue Light Therapy | Percentage of Participants in Each Group With Positive C. Acnes Cultures | Control Arm after CHX | 80.0 percent |
| 5% Topical Benzoyl Peroxide Gel | Percentage of Participants in Each Group With Positive C. Acnes Cultures | Treatment plus CHX Arm | 15.0 percent |
| 5% Topical Benzoyl Peroxide Gel | Percentage of Participants in Each Group With Positive C. Acnes Cultures | Control Arm after CHX | 85.0 percent |
| Light and Gel | Percentage of Participants in Each Group With Positive C. Acnes Cultures | Treatment plus CHX Arm | 40.0 percent |
| Light and Gel | Percentage of Participants in Each Group With Positive C. Acnes Cultures | Control Arm after CHX | 70.0 percent |