Trial Outcomes & Findings for A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne (NCT NCT03709654)
NCT ID: NCT03709654
Last Updated: 2020-08-03
Results Overview
Local Skin Reactions (LSRs) including Erythema, edema, erosion/ulceration, scaling/dryness, and scabbing/crusting scored at Baseline (day of first application) and Week 12 (end of treatment) and reported for each visit as: Absent, Mild, Moderate, or Severe. The number of participants (and %) with no change or improvement from Baseline to week 12 visit are reported. The number of participants (and %) whose score worsened from Baseline to week 12 visit are reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Day 0 through day 80
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
Treatment Arm
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
13
|
|
Overall Study
COMPLETED
|
20
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Treatment Arm
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=23 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 6.19 • n=93 Participants
|
24.6 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
24.4 years
STANDARD_DEVIATION 5.63 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=93 Participants
|
13 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Investigator's Global Assessment (IGA) Score - Face
IGA at Screening
|
3 Score on scale
STANDARD_DEVIATION 0 • n=93 Participants
|
3 Score on scale
STANDARD_DEVIATION 0 • n=4 Participants
|
3 Score on scale
STANDARD_DEVIATION 0 • n=27 Participants
|
|
Investigator's Global Assessment (IGA) Score - Face
IGA at Baseline
|
3 Score on scale
STANDARD_DEVIATION 0 • n=93 Participants
|
3 Score on scale
STANDARD_DEVIATION 0 • n=4 Participants
|
3 Score on scale
STANDARD_DEVIATION 0 • n=27 Participants
|
|
Skin bacterial genotype
deoR/Panbac
|
21.8 percentage of genotype
STANDARD_DEVIATION 24.2 • n=93 Participants
|
26.0 percentage of genotype
STANDARD_DEVIATION 27.4 • n=4 Participants
|
23.3 percentage of genotype
STANDARD_DEVIATION 25.4 • n=27 Participants
|
|
Skin bacterial genotype
Cas5/Panbac
|
7.3 percentage of genotype
STANDARD_DEVIATION 12.8 • n=93 Participants
|
7.8 percentage of genotype
STANDARD_DEVIATION 13.0 • n=4 Participants
|
7.5 percentage of genotype
STANDARD_DEVIATION 12.9 • n=27 Participants
|
|
Lesion Count
Inflammatory lesions
|
29.1 number of lesions
STANDARD_DEVIATION 7.3 • n=93 Participants
|
30.5 number of lesions
STANDARD_DEVIATION 5.6 • n=4 Participants
|
29.6 number of lesions
STANDARD_DEVIATION 6.7 • n=27 Participants
|
|
Lesion Count
Non-Inflammatory lesions
|
35.9 number of lesions
STANDARD_DEVIATION 13.5 • n=93 Participants
|
37.4 number of lesions
STANDARD_DEVIATION 12.8 • n=4 Participants
|
36.4 number of lesions
STANDARD_DEVIATION 13.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: The Safety population included all randomized subjects who received and applied study drug.
Local Skin Reactions (LSRs) including Erythema, edema, erosion/ulceration, scaling/dryness, and scabbing/crusting scored at Baseline (day of first application) and Week 12 (end of treatment) and reported for each visit as: Absent, Mild, Moderate, or Severe. The number of participants (and %) with no change or improvement from Baseline to week 12 visit are reported. The number of participants (and %) whose score worsened from Baseline to week 12 visit are reported.
Outcome measures
| Measure |
Treatment Arm
n=21 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=12 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Number of Participants With Changes in Local Skin Reactions
Erythema: No Change / Improved
|
19 Participants
|
11 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Erythema: Worsened
|
2 Participants
|
1 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Edema: No Change / Improved
|
19 Participants
|
9 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Edema: Worsened
|
2 Participants
|
3 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Erosion/Ulceration: No Change / Improved
|
20 Participants
|
12 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Erosion/Ulceration: Worsened
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Scaling/Dryness: No Change / Improved
|
16 Participants
|
11 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Scaling/Dryness: Worsened
|
5 Participants
|
1 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Scabbing/Crusting: No Change / Improved
|
19 Participants
|
12 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Scabbing/Crusting: Worsened
|
2 Participants
|
0 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Itching: No Change / Improved
|
15 Participants
|
11 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Itching: Worsened
|
6 Participants
|
1 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Pain: No Change / Improved
|
20 Participants
|
12 Participants
|
|
Number of Participants With Changes in Local Skin Reactions
Pain: Worsened
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The modified intent-to-treat (mITT) population included all randomized subjects who were dispensed the study drug and had at least 1 post-baseline assessment. Subjects were included in the treatment group to which they were randomized, regardless of the treatment received. All randomized subjects (N=36) were included in the mITT population.
Follicular engraftment sampling used Biore® Strips at Screening and day 80 (several days after end of treatment). The number of subjects with "success" at EOT where "success" is defined as a Follicular Biore® sample with "yes" outcome based on recovery of live NB01at day 80.
Outcome measures
| Measure |
Treatment Arm
n=23 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Number of Participants With Successful Follicular Engraftment of NB01
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: modified intent-to-treat (mITT)
Skin surface engraftment "success" endpoint is defined by a change in genotype (TaqMan) markers compared to Screening; value is percentage of bacterial population containing health-associated genotype. Result is absolute change from screening value.
Outcome measures
| Measure |
Treatment Arm
n=23 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
Genotype 1 (deoR), 2 weeks
|
6.9 percentage of bacterial population
Standard Deviation 20.32
|
2.5 percentage of bacterial population
Standard Deviation 14.17
|
|
Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
Genotype 1 (deoR), 7 weeks
|
5.5 percentage of bacterial population
Standard Deviation 17.63
|
2.9 percentage of bacterial population
Standard Deviation 16.96
|
|
Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
Genotype 1 (deoR), 12 weeks
|
3.9 percentage of bacterial population
Standard Deviation 25.27
|
14.9 percentage of bacterial population
Standard Deviation 36.76
|
|
Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
Genotype 2 (Cas 5), 2 weeks
|
3.7 percentage of bacterial population
Standard Deviation 8.16
|
4.8 percentage of bacterial population
Standard Deviation 12.56
|
|
Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
Genotype 2 (Cas 5), 7 weeks
|
6.6 percentage of bacterial population
Standard Deviation 17.84
|
3.9 percentage of bacterial population
Standard Deviation 10.42
|
|
Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
Genotype 2 (Cas 5), 12 weeks
|
4.0 percentage of bacterial population
Standard Deviation 10.32
|
19.6 percentage of bacterial population
Standard Deviation 38.69
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: modified intent-to-treat (mITT) population
Reporting absolute change in counts.
Outcome measures
| Measure |
Treatment Arm
n=23 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Absolute Change From Screening in Acne Lesion Counts
Inflammatory Lesion Count: week 2
|
-4.3 lesion count
Standard Deviation 4.77
|
-4.7 lesion count
Standard Deviation 6.8
|
|
Absolute Change From Screening in Acne Lesion Counts
Inflammatory Lesion Count: week 7
|
-8.4 lesion count
Standard Deviation 6.64
|
-6.7 lesion count
Standard Deviation 7.32
|
|
Absolute Change From Screening in Acne Lesion Counts
Inflammatory Lesion Count: week 12
|
-15.5 lesion count
Standard Deviation 7.84
|
-14.5 lesion count
Standard Deviation 9.56
|
|
Absolute Change From Screening in Acne Lesion Counts
Non-Inflammatory Lesion Count: week 2
|
-1.9 lesion count
Standard Deviation 8.89
|
-3.0 lesion count
Standard Deviation 6.30
|
|
Absolute Change From Screening in Acne Lesion Counts
Non-Inflammatory Lesion Count: week 7
|
-8.6 lesion count
Standard Deviation 8.58
|
-9.2 lesion count
Standard Deviation 8.52
|
|
Absolute Change From Screening in Acne Lesion Counts
Non-Inflammatory Lesion Count: week 12
|
-15 lesion count
Standard Deviation 16.93
|
-17.6 lesion count
Standard Deviation 10.66
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: modified intent-to-treat (mITT) population
Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Outcome measures
| Measure |
Treatment Arm
n=23 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Percent Change From Screening in Acne Lesion Counts
Inflammatory Lesion Count: week 2
|
-15.8 percent change from Baseline
Standard Deviation 18.72
|
-14.8 percent change from Baseline
Standard Deviation 20.1
|
|
Percent Change From Screening in Acne Lesion Counts
Inflammatory Lesion Count: week 7
|
-28.9 percent change from Baseline
Standard Deviation 20.72
|
-20.0 percent change from Baseline
Standard Deviation 22.41
|
|
Percent Change From Screening in Acne Lesion Counts
Inflammatory Lesion Count: week 12
|
-54.8 percent change from Baseline
Standard Deviation 26.29
|
-49.2 percent change from Baseline
Standard Deviation 27.19
|
|
Percent Change From Screening in Acne Lesion Counts
Non-Inflammatory Lesion Count: week 2
|
-5.8 percent change from Baseline
Standard Deviation 23.99
|
-6.2 percent change from Baseline
Standard Deviation 16.09
|
|
Percent Change From Screening in Acne Lesion Counts
Non-Inflammatory Lesion Count: week 7
|
-25.0 percent change from Baseline
Standard Deviation 23.55
|
-21.5 percent change from Baseline
Standard Deviation 17.93
|
|
Percent Change From Screening in Acne Lesion Counts
Non-Inflammatory Lesion Count: week 12
|
-43.5 percent change from Baseline
Standard Deviation 44.96
|
-49 percent change from Baseline
Standard Deviation 23.84
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: modified intent-to-treat (mITT) population
The investigator assessed the participant's inflammatory lesions on the face using the Investigator Global Assessment (IGA) 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules. The outcome is the number of subjects in each treatment group achieving "success" at Week 12; "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Outcome measures
| Measure |
Treatment Arm
n=23 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Number of Participants Achieving "Success" on Investigator Global Assessment (IGA)
Success at 7 weeks
|
1 Participants
|
0 Participants
|
|
Number of Participants Achieving "Success" on Investigator Global Assessment (IGA)
Success at 12 weeks
|
6 Participants
|
1 Participants
|
|
Number of Participants Achieving "Success" on Investigator Global Assessment (IGA)
Success at 2 weeks
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: modified intent-to-treat (mITT) population
At each visit, subjects were asked to complete the Acne Quality of Life \[QoL\] Questionnaire to assess subjective improvement of acne with 7 response choices ranging from extremely to not at all. The total score ranges from 19 to 114; higher scores reflect improved QoL. Outcome measure is absolute change in Acne QoL (Total Score) from Baseline to Day 80.
Outcome measures
| Measure |
Treatment Arm
n=23 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Change in Acne QoL Questionnaire Score
|
9.7 score on a scale
Standard Deviation 16.2
|
33.2 score on a scale
Standard Deviation 23.65
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: Ad Hoc Subject 02-005 (outlier) Censored mITT Population
After reviewing the data, one Treatment Arm subject was found to be an extreme outlier and was censored from this ad-hoc analysis. Reporting absolute change in counts.
Outcome measures
| Measure |
Treatment Arm
n=22 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
Inflammatory Lesion Count: week 2
|
-4.2 lesion count
Standard Deviation 4.82
|
-4.7 lesion count
Standard Deviation 6.8
|
|
Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
Inflammatory Lesion Count: week 7
|
-8.5 lesion count
Standard Deviation 6.81
|
-6.7 lesion count
Standard Deviation 7.32
|
|
Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
Inflammatory Lesion Count: week 12
|
-15.1 lesion count
Standard Deviation 7.79
|
-14.5 lesion count
Standard Deviation 9.56
|
|
Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
Non-Inflammatory Lesion Count: week 2
|
-3.6 lesion count
Standard Deviation 2.77
|
-3.0 lesion count
Standard Deviation 6.30
|
|
Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
Non-Inflammatory Lesion Count: week 7
|
-9.7 lesion count
Standard Deviation 7.35
|
-9.2 lesion count
Standard Deviation 8.52
|
|
Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
Non-Inflammatory Lesion Count: week 12
|
-18 lesion count
Standard Deviation 10.31
|
-17.6 lesion count
Standard Deviation 10.66
|
PRIMARY outcome
Timeframe: Day 0 through day 80Population: Ad Hoc Subject 02-005 Censored mITT Population
Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Outcome measures
| Measure |
Treatment Arm
n=22 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Inflammatory Lesion Count: week 2
|
-15.2 percent change from Baseline
Standard Deviation 18.91
|
-14.8 percent change from Baseline
Standard Deviation 20.10
|
|
Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Inflammatory Lesion Count: week 7
|
-29.0 percent change from Baseline
Standard Deviation 21.25
|
-20.0 percent change from Baseline
Standard Deviation 22.41
|
|
Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Inflammatory Lesion Count: week 12
|
-53.0 percent change from Baseline
Standard Deviation 25.72
|
-49.2 percent change from Baseline
Standard Deviation 27.19
|
|
Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Non-Inflammatory Lesion Count: week 2
|
-10.5 percent change from Baseline
Standard Deviation 8.55
|
-6.2 percent change from Baseline
Standard Deviation 16.09
|
|
Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Non-Inflammatory Lesion Count: week 7
|
-27.8 percent change from Baseline
Standard Deviation 20.18
|
-21.5 percent change from Baseline
Standard Deviation 17.93
|
|
Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Non-Inflammatory Lesion Count: week 12
|
-51.8 percent change from Baseline
Standard Deviation 26.42
|
-49.0 percent change from Baseline
Standard Deviation 23.84
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: modified intent-to-treat (mITT) population
Follicular communities were genotyped for health-associated loci at both Screening and 12-week visits. The percent increase of Cas5 in multiple communities from each subject is reported.
Outcome measures
| Measure |
Treatment Arm
n=20 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=11 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Follicular Engraftment
|
6518.9 Percent increase Cas5
Standard Deviation 6711.94
|
492 Percent increase Cas5
Standard Deviation 939.20
|
SECONDARY outcome
Timeframe: Day 0 through day 80Population: modified intent-to-treat subpopulation visiting a subset of sites with a Sebumeter.
Exploratory Endpoint: Absolute change from Baseline to week 12 in sebum production measured at the mid-glabellar region of the forehead using a Sebumeter.
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=9 Participants
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
Absolute Change in Sebum Production.
|
26.2 μg/cm^2
Standard Deviation 52.48
|
-22.9 μg/cm^2
Standard Deviation 34.47
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vehicle Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=23 participants at risk
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
NB01: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
|
Vehicle Control
n=13 participants at risk
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Vehicle Control: 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
|
|---|---|---|
|
General disorders
Application site dryness
|
8.7%
2/23 • Number of events 2 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
General disorders
Application site irritation
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
General disorders
Influenza like illness
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place