A Phase 4 interventional study of 5% Topical Benzoyl Peroxide Gel and Blue Light Therapy in Acne, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
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.
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 60 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Gel treatment used to treat acne
Blue light therapy treatment for acne
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
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
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
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
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.
| Milestone | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Control Shoulder |
|---|---|---|---|---|
| Started | 20 | 20 | 20 | 60 |
| Completed | 20 | 20 | 20 | 60 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Participants | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel |
|---|---|---|---|
| Number of Participants With C. Acnes Bacterium Culture After Treatment | 20 | 20 | 16 |
Quantitative culture analysis between treatment groups after treatment to the shoulder but before chlorhexidine preparation (null condition).
| CFU/mL | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel |
|---|---|---|---|
| Median Colony Forming Units (CFU) After Treatment | 304000 (77800 to 915000) | 28500 (10300 to 89000) | 12100 (300 to 143000) |
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.
| percent | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel |
|---|---|---|---|
| Treatment plus CHX Arm | 90.0 (67.6 to 97.5) | 15.0 (4.9 to 37.6) | 40.0 (21.4 to 62.0) |
| Control Arm after CHX | 80.0 (57.2 to 92.3) | 85.0 (62.4 to 95.1) | 70.0 (47.3 to 85.9) |
Samples taken from treatment arm and control arm after chlorhexidine (CHX) preparation on both sides.
| CFU/mL | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel |
|---|---|---|---|
| Treatment plus CHX Arm | 50000 (17000 to 247000) | 2000 (2000 to 2000) | 2000 (2000 to 11300) |
| Control Arm after CHX | 108000 (4000 to 254000) | 41500 (2000 to 96000) | 20000 (2000 to 258000) |
Collected over Participants were contacted at least 1 week following the final research visit to ask for any delayed side effects of treatments, up to 2 weeks on study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blue Light Therapy | 0/20 (0%) | 0/20 (0%) | 6/20 (30%) |
| 5% Topical Benzoyl Peroxide Gel | 0/20 (0%) | 0/20 (0%) | 6/20 (30%) |
| Light and Gel | 0/20 (0%) | 0/20 (0%) | 6/20 (30%) |
| Control Shoulder | 0/60 (0%) | 0/60 (0%) | 2/60 (3.3%) |
| Event | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Control Shoulder |
|---|---|---|---|---|
| ErythemaInjury, poisoning and procedural complications | 3/20 | 2/20 | 4/20 | 1/60 |
| Itching or BurningInjury, poisoning and procedural complications | 0/20 | 3/20 | 0/20 | 0/60 |
| Skin Dryness, Peeling, or FlakingInjury, poisoning and procedural complications | 0/20 | 2/20 | 2/20 | 1/60 |
| bleaching of clothingProduct Issues | 0/20 | 2/20 | 0/20 | 0/60 |
| HyperpigmentationInjury, poisoning and procedural complications | 2/20 | 0/20 | 0/20 | 0/60 |
| Warmth at Treatment SiteInjury, poisoning and procedural complications | 1/20 | 0/20 | 1/20 | 0/60 |
| Age, Continuous(years) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| Mean | 26.70 ± 2.99 | 26.80 ± 3.62 | 25.90 ± 2.97 | 26.47 ± 2.97 |
| Sex: Female, Male(Participants) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 20 | 20 | 20 | 60 |
| Ethnicity (NIH/OMB)(Participants) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 | 4 |
| Not Hispanic or Latino | 19 | 19 | 18 | 56 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 4 | 3 | 3 | 10 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 1 | 1 | 0 | 2 |
| White | 13 | 14 | 15 | 42 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 | 4 |
| Region of Enrollment(participants) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| United States | 20 | 20 | 20 | 60 |
| Body Mass Index (BMI)(kg/m^2) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| Mean | 24.60 ± 3.49 | 24.56 ± 2.30 | 24.63 ± 3.92 | 24.60 ± 3.67 |
| Occupation(Participants) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| Student | 15 | 13 | 16 | 44 |
| Resident | 5 | 7 | 3 | 15 |
| Other Healthcare Professional | 0 | 0 | 1 | 1 |
| Asthma(Participants) | Blue Light Therapy | 5% Topical Benzoyl Peroxide Gel | Light and Gel | Total |
|---|---|---|---|---|
| Count of participants | 2 | 3 | 0 | 5 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of Wisconsin, Madison