Trial Outcomes & Findings for Blue Light Therapy of C. Acnes (NCT NCT04300010)
NCT ID: NCT04300010
Last Updated: 2022-05-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
up to 2 days
Results posted on
2022-05-10
Participant Flow
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.
Unit of analysis: shoulders
Participant milestones
| Measure |
Blue Light Therapy
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. 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.
|
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.
|
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.
|
Control Shoulder
All participants will have their contralateral shoulder serve as the control (2% chlorhexidine gluconate with 70% isopropyl alcohol only)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20 20
|
20 20
|
20 20
|
60 60
|
|
Overall Study
COMPLETED
|
20 20
|
20 20
|
20 20
|
60 60
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blue Light Therapy of C. Acnes
Baseline characteristics by cohort
| Measure |
Blue Light Therapy
n=20 Participants
Blue Light Therapy: Blue light therapy treatment for acne
|
5% Topical Benzoyl Peroxide Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
|
Light and Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
Blue Light Therapy: Blue light therapy treatment for acne
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.70 years
STANDARD_DEVIATION 2.99 • n=99 Participants
|
26.80 years
STANDARD_DEVIATION 3.62 • n=107 Participants
|
25.90 years
STANDARD_DEVIATION 2.97 • n=206 Participants
|
26.47 years
STANDARD_DEVIATION 2.97 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
20 participants
n=206 Participants
|
60 participants
n=7 Participants
|
|
Body Mass Index (BMI)
|
24.60 kg/m^2
STANDARD_DEVIATION 3.49 • n=99 Participants
|
24.56 kg/m^2
STANDARD_DEVIATION 2.30 • n=107 Participants
|
24.63 kg/m^2
STANDARD_DEVIATION 3.92 • n=206 Participants
|
24.60 kg/m^2
STANDARD_DEVIATION 3.67 • n=7 Participants
|
|
Occupation
Student
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Occupation
Resident
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Occupation
Other Healthcare Professional
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Asthma
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Autoimmune Condition
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Infection Requiring Intravenous Antibiotics
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Consume Alcohol
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Number of Alcohol Drinks per Week
|
2.05 drinks per week
STANDARD_DEVIATION 1.78 • n=99 Participants
|
2.15 drinks per week
STANDARD_DEVIATION 1.91 • n=107 Participants
|
2.58 drinks per week
STANDARD_DEVIATION 2.01 • n=206 Participants
|
2.26 drinks per week
STANDARD_DEVIATION 1.89 • n=7 Participants
|
PRIMARY outcome
Timeframe: up to 2 daysSwab 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.
Outcome measures
| Measure |
Blue Light Therapy
n=20 Participants
Blue Light Therapy: Blue light therapy treatment for acne
|
5% Topical Benzoyl Peroxide Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
|
Light and Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
Blue Light Therapy: Blue light therapy treatment for acne
|
|---|---|---|---|
|
Number of Participants With C. Acnes Bacterium Culture After Treatment
|
20 Participants
|
20 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: up to 2 daysQuantitative culture analysis between treatment groups after treatment to the shoulder but before chlorhexidine preparation (null condition).
Outcome measures
| Measure |
Blue Light Therapy
n=20 Participants
Blue Light Therapy: Blue light therapy treatment for acne
|
5% Topical Benzoyl Peroxide Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
|
Light and Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
Blue Light Therapy: Blue light therapy treatment for acne
|
|---|---|---|---|
|
Median Colony Forming Units (CFU) After Treatment
|
304000 CFU/mL
Interval 77800.0 to 915000.0
|
28500 CFU/mL
Interval 10300.0 to 89000.0
|
12100 CFU/mL
Interval 300.0 to 143000.0
|
PRIMARY outcome
Timeframe: up to 2 daysComparison 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.
Outcome measures
| Measure |
Blue Light Therapy
n=20 Participants
Blue Light Therapy: Blue light therapy treatment for acne
|
5% Topical Benzoyl Peroxide Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
|
Light and Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
Blue Light Therapy: Blue light therapy treatment for acne
|
|---|---|---|---|
|
Percentage of Participants in Each Group With Positive C. Acnes Cultures
Treatment plus CHX Arm
|
90.0 percent
Interval 67.6 to 97.5
|
15.0 percent
Interval 4.9 to 37.6
|
40.0 percent
Interval 21.4 to 62.0
|
|
Percentage of Participants in Each Group With Positive C. Acnes Cultures
Control Arm after CHX
|
80.0 percent
Interval 57.2 to 92.3
|
85.0 percent
Interval 62.4 to 95.1
|
70.0 percent
Interval 47.3 to 85.9
|
PRIMARY outcome
Timeframe: up to 2 daysSamples taken from treatment arm and control arm after chlorhexidine (CHX) preparation on both sides.
Outcome measures
| Measure |
Blue Light Therapy
n=20 Participants
Blue Light Therapy: Blue light therapy treatment for acne
|
5% Topical Benzoyl Peroxide Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
|
Light and Gel
n=20 Participants
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
Blue Light Therapy: Blue light therapy treatment for acne
|
|---|---|---|---|
|
Median Colony Forming Units Per mL Treatment vs Control
Treatment plus CHX Arm
|
50000 CFU/mL
Interval 17000.0 to 247000.0
|
2000 CFU/mL
Interval 2000.0 to 2000.0
|
2000 CFU/mL
Interval 2000.0 to 11300.0
|
|
Median Colony Forming Units Per mL Treatment vs Control
Control Arm after CHX
|
108000 CFU/mL
Interval 4000.0 to 254000.0
|
41500 CFU/mL
Interval 2000.0 to 96000.0
|
20000 CFU/mL
Interval 2000.0 to 258000.0
|
Adverse Events
Blue Light Therapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
5% Topical Benzoyl Peroxide Gel
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Light and Gel
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control Shoulder
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blue Light Therapy
n=20 participants at risk
Blue Light Therapy: Blue light therapy treatment for acne
|
5% Topical Benzoyl Peroxide Gel
n=20 participants at risk
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
|
Light and Gel
n=20 participants at risk
5% Topical Benzoyl Peroxide Gel: Gel treatment used to treat acne
Blue Light Therapy: Blue light therapy treatment for acne
|
Control Shoulder
n=60 participants at risk
All participants will have their contralateral shoulder serve as the control (2% chlorhexidine gluconate with 70% isopropyl alcohol only)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Itching or Burning
|
0.00%
0/20 • 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
|
15.0%
3/20 • 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
|
0.00%
0/20 • 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
|
0.00%
0/60 • 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
|
|
Injury, poisoning and procedural complications
Skin Dryness, Peeling, or Flaking
|
0.00%
0/20 • 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
|
10.0%
2/20 • 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
|
10.0%
2/20 • 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
|
1.7%
1/60 • 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
|
|
Product Issues
bleaching of clothing
|
0.00%
0/20 • 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
|
10.0%
2/20 • 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
|
0.00%
0/20 • 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
|
0.00%
0/60 • 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
|
|
Injury, poisoning and procedural complications
Erythema
|
15.0%
3/20 • 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
|
10.0%
2/20 • 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
|
20.0%
4/20 • 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
|
1.7%
1/60 • 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
|
|
Injury, poisoning and procedural complications
Hyperpigmentation
|
10.0%
2/20 • 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
|
0.00%
0/20 • 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
|
0.00%
0/20 • 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
|
0.00%
0/60 • 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
|
|
Injury, poisoning and procedural complications
Warmth at Treatment Site
|
5.0%
1/20 • 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
|
0.00%
0/20 • 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
|
5.0%
1/20 • 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
|
0.00%
0/60 • 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
|
Additional Information
Eric Cotter, MD
UW School of Medicine and Public Health
Phone: 920.362.9221
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place