A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
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ClinicalTrials.gov Identifier: NCT03709654 |
Recruitment Status :
Completed
First Posted : October 17, 2018
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Acne Vulgaris |
Interventions |
Biological: NB01 Other: Vehicle Control |
Enrollment | 36 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Treatment Arm | Vehicle Control |
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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 |
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 |
Period Title: Overall Study | ||
Started | 23 | 13 |
Completed | 20 | 11 |
Not Completed | 3 | 2 |
Reason Not Completed | ||
Lost to Follow-up | 1 | 1 |
Withdrawal by Subject | 1 | 1 |
Adverse Event | 1 | 0 |
Arm/Group Title | Treatment Arm | Vehicle Control | Total | |
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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 |
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 of all reporting groups | |
Overall Number of Baseline Participants | 23 | 13 | 36 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 23 participants | 13 participants | 36 participants | |
24.3 (6.19) | 24.6 (4.7) | 24.4 (5.63) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 13 participants | 36 participants | |
Female |
16 69.6%
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8 61.5%
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24 66.7%
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Male |
7 30.4%
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5 38.5%
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12 33.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 13 participants | 36 participants | |
Hispanic or Latino |
10 43.5%
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7 53.8%
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17 47.2%
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Not Hispanic or Latino |
13 56.5%
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6 46.2%
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19 52.8%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 13 participants | 36 participants | |
American Indian or Alaska Native |
2 8.7%
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0 0.0%
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2 5.6%
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Asian |
0 0.0%
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1 7.7%
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1 2.8%
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Native Hawaiian or Other Pacific Islander |
1 4.3%
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0 0.0%
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1 2.8%
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Black or African American |
3 13.0%
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0 0.0%
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3 8.3%
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White |
17 73.9%
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12 92.3%
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29 80.6%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 23 participants | 13 participants | 36 participants |
23 | 13 | 36 | ||
Investigator's Global Assessment (IGA) Score - Face
[1] Mean (Standard Deviation) Unit of measure: Score on scale |
Number Analyzed | 23 participants | 13 participants | 36 participants |
IGA at Screening | 3 (0) | 3 (0) | 3 (0) | |
IGA at Baseline | 3 (0) | 3 (0) | 3 (0) | |
[1]
Measure Description:
The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale at screening visit and baseline visits. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): |
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Skin bacterial genotype
[1] Mean (Standard Deviation) Unit of measure: Percentage of genotype |
Number Analyzed | 23 participants | 13 participants | 36 participants |
deoR/Panbac | 21.8 (24.2) | 26.0 (27.4) | 23.3 (25.4) | |
Cas5/Panbac | 7.3 (12.8) | 7.8 (13.0) | 7.5 (12.9) | |
[1]
Measure Description: Skin genotype is the percentage of bacterial population containing health-associated genotypes as measured with TaqMan from a skin swabbed sample.
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Lesion Count
Mean (Standard Deviation) Unit of measure: Number of lesions |
Number Analyzed | 23 participants | 13 participants | 36 participants |
Inflammatory lesions | 29.1 (7.3) | 30.5 (5.6) | 29.6 (6.7) | |
Non-Inflammatory lesions | 35.9 (13.5) | 37.4 (12.8) | 36.4 (13.2) |
Name/Title: | Emma Taylor, MD CEO |
Organization: | Naked Biome |
Phone: | 626-260-1230 |
EMail: | emma.t@nakedbiome.com |
Responsible Party: | Naked Biome, Inc. |
ClinicalTrials.gov Identifier: | NCT03709654 |
Other Study ID Numbers: |
NB01-P1BMA |
First Submitted: | October 9, 2018 |
First Posted: | October 17, 2018 |
Results First Submitted: | June 4, 2020 |
Results First Posted: | August 3, 2020 |
Last Update Posted: | August 3, 2020 |