Trial Outcomes & Findings for A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne (NCT NCT03450369)
NCT ID: NCT03450369
Last Updated: 2020-08-03
Results Overview
Engraftment is defined as the percentage of bacteria recovered from hair follicles that are health-associated (NB01) as measured with proprietary quantitative polymerase chain assays. Successful follicular engraftment, defined as both deoR/PanBac \>40% and Cas5/PanBac \>40% in the Day 2 (24H) ) Biore Strip samples. Cas5/PanBac and deoR/PanBac are the percentages of bacteria in a sample containing the CRISPR associated protein Cas5 and a repressor of porphyrin production deoR, respectively. Pan-Bacterial (PanBac) is a loci found in nearly all bacteria found on the face and thus serves as the denominator to calculate the percentage of bacteria with any loci.
COMPLETED
PHASE1
10 participants
2 Months
2020-08-03
Participant Flow
Participant milestones
| Measure |
Low Dose
10\^4 CFU/cm\^2 NB01 colony forming unit (CFU)
|
High Dose
10\^5 CFU/cm\^2 NB01 colony forming unit (CFU)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne
Baseline characteristics by cohort
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.6 years
STANDARD_DEVIATION 4.77 • n=5 Participants
|
26.6 years
STANDARD_DEVIATION 3.78 • n=7 Participants
|
24.6 years
STANDARD_DEVIATION 4.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Reproductive Status
Able to bear children
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Reproductive Status
Total abstinence (male)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Method of Contraception (Female)
Total abstinence
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Method of Contraception (Female)
Barrier method with spermicide
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Method of Contraception (Female)
Oral, injected or implanted combined hormonal meth
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Method of Contraception (Female)
male subject: not recorded
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA) Score - Face
|
3 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
3 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
3 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 MonthsEngraftment is defined as the percentage of bacteria recovered from hair follicles that are health-associated (NB01) as measured with proprietary quantitative polymerase chain assays. Successful follicular engraftment, defined as both deoR/PanBac \>40% and Cas5/PanBac \>40% in the Day 2 (24H) ) Biore Strip samples. Cas5/PanBac and deoR/PanBac are the percentages of bacteria in a sample containing the CRISPR associated protein Cas5 and a repressor of porphyrin production deoR, respectively. Pan-Bacterial (PanBac) is a loci found in nearly all bacteria found on the face and thus serves as the denominator to calculate the percentage of bacteria with any loci.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Successful Engraftment of Probiotic Following a Single Application.
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 48 hours after applicationTo determine longevity of the live biotherapeutic after a single application, swab samples were collected at Baseline, 6, 24 and 48 hours after application, and genotyped as above. For each participant the absolute change, from Baseline, in the percentage of the two loci present in the live biotherapeutic (deoR and Cas5) were calculated. A significant positive change is indicative of the continued presence of the live biotherapeutic.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Dose Schedule Determination Based on Time to Peak deoR and Cas5
Genotype 1 (deoR), 6 hours
|
-0.4 % of total bacteria w/ genotype
Standard Deviation 36.3
|
51.2 % of total bacteria w/ genotype
Standard Deviation 28.6
|
|
Dose Schedule Determination Based on Time to Peak deoR and Cas5
Genotype 1 (deoR), 24 hours
|
-4.2 % of total bacteria w/ genotype
Standard Deviation 25.7
|
5.2 % of total bacteria w/ genotype
Standard Deviation 7.6
|
|
Dose Schedule Determination Based on Time to Peak deoR and Cas5
Genotype 1 (deoR), 48 hours
|
13.8 % of total bacteria w/ genotype
Standard Deviation 33.5
|
2.8 % of total bacteria w/ genotype
Standard Deviation 10.9
|
|
Dose Schedule Determination Based on Time to Peak deoR and Cas5
Genotype 2 (Cas 5), 6 hours
|
12.8 % of total bacteria w/ genotype
Standard Deviation 27.9
|
48.4 % of total bacteria w/ genotype
Standard Deviation 21.7
|
|
Dose Schedule Determination Based on Time to Peak deoR and Cas5
Genotype 2 (Cas 5), 24 hours
|
3.4 % of total bacteria w/ genotype
Standard Deviation 15.6
|
4.4 % of total bacteria w/ genotype
Standard Deviation 8.8
|
|
Dose Schedule Determination Based on Time to Peak deoR and Cas5
Genotype 2 (Cas 5), 48 hours
|
3.2 % of total bacteria w/ genotype
Standard Deviation 12.2
|
1.8 % of total bacteria w/ genotype
Standard Deviation 12.1
|
PRIMARY outcome
Timeframe: 28 DaysNumber of participants with a changed Investigator Global Assessment (IGA) score after single application of NB01; positive number if grade is reduced (e.g. from 3 to 2) or negative number is IGA grade increased. The Investigator Global Assessment 5-Point Score is a standard FDA acne assessment tool with scoring as follows: Grade 0-Clear (Clear skin with no inflammatory or non-inflammatory lesions. The category of clear should represent true absence of disease) Grade1-Almost Clear (A few scattered comedones and no more than one small papule) Grade 2-Mild (Some comedones, some papules and pustules; no nodules) Grade 3-Moderate (Many comedones, papules and pustules; one nodule may be present) Grade 4-Severe (Covered with comedones, numerous papules and pustules and no more than a few nodular lesions)
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Global Assessment (IGA) Score
Participants with changed IGA @ 6 hours
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Global Assessment (IGA) Score
Participants with changed IGA @ 1 day
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Global Assessment (IGA) Score
Participants with changed IGA @ 2 days
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Global Assessment (IGA) Score
Participants with changed IGA @ 6 days
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Global Assessment (IGA) Score
Participants with changed IGA @ 28 days
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Absolute Lesion Count: All Lesions for the Whole Face; with higher numbers of lesion representing worsening or more severe acne
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Screening
|
49.4 count of lesions
Standard Deviation 21.08
|
38.8 count of lesions
Standard Deviation 16.60
|
|
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Day 1 (0 hours)
|
22.6 count of lesions
Standard Deviation 13.26
|
42.6 count of lesions
Standard Deviation 3.8
|
|
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Day 1 (6 hours)
|
21.0 count of lesions
Standard Deviation 9.22
|
39.8 count of lesions
Standard Deviation 25.41
|
|
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Day 2
|
31.6 count of lesions
Standard Deviation 3.51
|
38.2 count of lesions
Standard Deviation 25.29
|
|
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Day 3
|
32.2 count of lesions
Standard Deviation 6.18
|
35.4 count of lesions
Standard Deviation 24.17
|
|
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Day 7
|
25.6 count of lesions
Standard Deviation 4.72
|
34.2 count of lesions
Standard Deviation 19.11
|
|
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Day 28
|
25.8 count of lesions
Standard Deviation 14.31
|
32.6 count of lesions
Standard Deviation 59.22
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Peeling. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Screening, scale = 1 (slight)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 28, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Screening, scale = 0 (none)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 1 (0 hours), scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 1 (0 hours), scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 1 (6 hours), scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 1 (6 hours), scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 2, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 3, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Day 7, scale = 0 (none)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Irritant/Allergic Contact Dermatitis. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Screening, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Day 1 (6 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Day 3, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Day 7, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Day 1 (0 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Day 2, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Day 28, scale = 0 (none)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Hyperpigmentation. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Day 1 (0 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Screening, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Day 1 (6 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Day 2, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Day 3, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Day 7, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Day 28, scale = 0 (none)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Ocular Irritation. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Day 7, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Day 28, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Screening, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Day 1 (0 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Day 1 (6 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Day 2, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Day 3, scale = 0 (none)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Conjunctival Injection. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Day 1 (6 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Screening, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Day 1 (0 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Day 2, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Day 3, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Day 7, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Day 28, scale = 0 (none)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Mucosal Toxicity. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Screening, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Day 1 (0 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Day 1 (6 hours), scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Day 2, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Day 3, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Day 7, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Day 28, scale = 0 (none)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Erythema. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Screening, scale = 0 (none)
|
2 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Screening, scale = 1 (slight)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 1 (0 hours), scale = 0 (none)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 1 (0 hours), scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 1 (0 hours), scale = 2 (moderate)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 1 (6 hours), scale = 0 (none)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 1 (6 hours), scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 1 (6 hours), scale = 2 (moderate)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 2, scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 2, scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 3, scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 3, scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 7, scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 7, scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Day 28, scale = 0 (none)
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Screening to 28 days after application, typically 2 monthsPopulation: All participants who received at least one dose of treatment.
Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Dryness. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.
Outcome measures
| Measure |
Low Dose
n=5 Participants
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 Participants
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Screening, scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Screening, scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 1 (0 hours), scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 3, scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 7, scale = 0 (none)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 28, scale = 0 (none)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 28, scale = 1 (slight)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 1 (0 hours), scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 1 (6 hours), scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 1 (6 hours), scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 2, scale = 0 (none)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 2, scale = 1 (slight)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Day 3, scale = 0 (none)
|
4 Participants
|
5 Participants
|
Adverse Events
Low Dose
High Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=5 participants at risk
10\^4 CFU/cm\^2 NB01
|
High Dose
n=5 participants at risk
10\^5 CFU/cm\^2 NB01
|
|---|---|---|
|
General disorders
Application site dermatitis
|
20.0%
1/5 • Number of events 1 • From Screening to 28 days after application, typically 2 months
|
0.00%
0/5 • From Screening to 28 days after application, typically 2 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • From Screening to 28 days after application, typically 2 months
|
20.0%
1/5 • Number of events 1 • From Screening to 28 days after application, typically 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place