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A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709654
Recruitment Status : Completed
First Posted : October 17, 2018
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Therapeutics, Inc.
Information provided by (Responsible Party):
Naked Biome, Inc.

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 23 participants 13 participants 36 participants
Female
16
  69.6%
8
  61.5%
24
  66.7%
Male
7
  30.4%
5
  38.5%
12
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 13 participants 36 participants
Hispanic or Latino
10
  43.5%
7
  53.8%
17
  47.2%
Not Hispanic or Latino
13
  56.5%
6
  46.2%
19
  52.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 13 participants 36 participants
American Indian or Alaska Native
2
   8.7%
0
   0.0%
2
   5.6%
Asian
0
   0.0%
1
   7.7%
1
   2.8%
Native Hawaiian or Other Pacific Islander
1
   4.3%
0
   0.0%
1
   2.8%
Black or African American
3
  13.0%
0
   0.0%
3
   8.3%
White
17
  73.9%
12
  92.3%
29
  80.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
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):

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.
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)
1.Primary Outcome
Title Number of Participants With Changes in Local Skin Reactions
Hide Description

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.

Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all randomized subjects who received and applied study drug.
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 21 12
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema: No Change / Improved
19
  90.5%
11
  91.7%
Erythema: Worsened
2
   9.5%
1
   8.3%
Edema: No Change / Improved
19
  90.5%
9
  75.0%
Edema: Worsened
2
   9.5%
3
  25.0%
Erosion/Ulceration: No Change / Improved
20
  95.2%
12
 100.0%
Erosion/Ulceration: Worsened
1
   4.8%
0
   0.0%
Scaling/Dryness: No Change / Improved
16
  76.2%
11
  91.7%
Scaling/Dryness: Worsened
5
  23.8%
1
   8.3%
Scabbing/Crusting: No Change / Improved
19
  90.5%
12
 100.0%
Scabbing/Crusting: Worsened
2
   9.5%
0
   0.0%
Itching: No Change / Improved
15
  71.4%
11
  91.7%
Itching: Worsened
6
  28.6%
1
   8.3%
Pain: No Change / Improved
20
  95.2%
12
 100.0%
Pain: Worsened
1
   4.8%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Successful Follicular Engraftment of NB01
Hide Description

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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 23 13
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.3%
0
   0.0%
3.Primary Outcome
Title Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
Hide Description 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.
Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat (mITT)
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 23 13
Mean (Standard Deviation)
Unit of Measure: percentage of bacterial population
Genotype 1 (deoR), 2 weeks 6.9  (20.32) 2.5  (14.17)
Genotype 1 (deoR), 7 weeks 5.5  (17.63) 2.9  (16.96)
Genotype 1 (deoR), 12 weeks 3.9  (25.27) 14.9  (36.76)
Genotype 2 (Cas 5), 2 weeks 3.7  (8.16) 4.8  (12.56)
Genotype 2 (Cas 5), 7 weeks 6.6  (17.84) 3.9  (10.42)
Genotype 2 (Cas 5), 12 weeks 4.0  (10.32) 19.6  (38.69)
4.Primary Outcome
Title Absolute Change From Screening in Acne Lesion Counts
Hide Description Reporting absolute change in counts.
Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat (mITT) population
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 23 13
Mean (Standard Deviation)
Unit of Measure: lesion count
Inflammatory Lesion Count: week 2 Number Analyzed 23 participants 13 participants
-4.3  (4.77) -4.7  (6.8)
Inflammatory Lesion Count: week 7 Number Analyzed 21 participants 12 participants
-8.4  (6.64) -6.7  (7.32)
Inflammatory Lesion Count: week 12 Number Analyzed 20 participants 11 participants
-15.5  (7.84) -14.5  (9.56)
Non-Inflammatory Lesion Count: week 2 Number Analyzed 23 participants 13 participants
-1.9  (8.89) -3.0  (6.30)
Non-Inflammatory Lesion Count: week 7 Number Analyzed 21 participants 12 participants
-8.6  (8.58) -9.2  (8.52)
Non-Inflammatory Lesion Count: week 12 Number Analyzed 20 participants 11 participants
-15  (16.93) -17.6  (10.66)
5.Primary Outcome
Title Percent Change From Screening in Acne Lesion Counts
Hide Description Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat (mITT) population
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 23 13
Mean (Standard Deviation)
Unit of Measure: percent change from Baseline
Inflammatory Lesion Count: week 2 Number Analyzed 23 participants 13 participants
-15.8  (18.72) -14.8  (20.1)
Inflammatory Lesion Count: week 7 Number Analyzed 21 participants 12 participants
-28.9  (20.72) -20.0  (22.41)
Inflammatory Lesion Count: week 12 Number Analyzed 20 participants 11 participants
-54.8  (26.29) -49.2  (27.19)
Non-Inflammatory Lesion Count: week 2 Number Analyzed 23 participants 13 participants
-5.8  (23.99) -6.2  (16.09)
Non-Inflammatory Lesion Count: week 7 Number Analyzed 21 participants 12 participants
-25.0  (23.55) -21.5  (17.93)
Non-Inflammatory Lesion Count: week 12 Number Analyzed 20 participants 11 participants
-43.5  (44.96) -49  (23.84)
6.Primary Outcome
Title Number of Participants Achieving "Success" on Investigator Global Assessment (IGA)
Hide Description

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.

Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat (mITT) population
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 23 13
Measure Type: Count of Participants
Unit of Measure: Participants
Success at 2 weeks
0
   0.0%
0
   0.0%
Success at 7 weeks
1
   4.3%
0
   0.0%
Success at 12 weeks
6
  26.1%
1
   7.7%
7.Primary Outcome
Title Change in Acne QoL Questionnaire Score
Hide Description

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.

Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat (mITT) population
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 23 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.7  (16.2) 33.2  (23.65)
8.Primary Outcome
Title Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
Hide Description

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.

Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
Ad Hoc Subject 02-005 (outlier) Censored mITT Population
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 22 13
Mean (Standard Deviation)
Unit of Measure: lesion count
Inflammatory Lesion Count: week 2 Number Analyzed 22 participants 13 participants
-4.2  (4.82) -4.7  (6.8)
Inflammatory Lesion Count: week 7 Number Analyzed 20 participants 12 participants
-8.5  (6.81) -6.7  (7.32)
Inflammatory Lesion Count: week 12 Number Analyzed 19 participants 11 participants
-15.1  (7.79) -14.5  (9.56)
Non-Inflammatory Lesion Count: week 2 Number Analyzed 22 participants 13 participants
-3.6  (2.77) -3.0  (6.30)
Non-Inflammatory Lesion Count: week 7 Number Analyzed 20 participants 12 participants
-9.7  (7.35) -9.2  (8.52)
Non-Inflammatory Lesion Count: week 12 Number Analyzed 19 participants 11 participants
-18  (10.31) -17.6  (10.66)
9.Primary Outcome
Title Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Hide Description Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
Ad Hoc Subject 02-005 Censored mITT Population
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 22 13
Mean (Standard Deviation)
Unit of Measure: percent change from Baseline
Inflammatory Lesion Count: week 2 Number Analyzed 22 participants 13 participants
-15.2  (18.91) -14.8  (20.10)
Inflammatory Lesion Count: week 7 Number Analyzed 20 participants 12 participants
-29.0  (21.25) -20.0  (22.41)
Inflammatory Lesion Count: week 12 Number Analyzed 19 participants 11 participants
-53.0  (25.72) -49.2  (27.19)
Non-Inflammatory Lesion Count: week 2 Number Analyzed 22 participants 13 participants
-10.5  (8.55) -6.2  (16.09)
Non-Inflammatory Lesion Count: week 7 Number Analyzed 20 participants 12 participants
-27.8  (20.18) -21.5  (17.93)
Non-Inflammatory Lesion Count: week 12 Number Analyzed 19 participants 11 participants
-51.8  (26.42) -49.0  (23.84)
10.Primary Outcome
Title Follicular Engraftment
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat (mITT) population
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 20 11
Mean (Standard Deviation)
Unit of Measure: Percent increase Cas5
6518.9  (6711.94) 492  (939.20)
11.Secondary Outcome
Title Absolute Change in Sebum Production.
Hide Description Exploratory Endpoint: Absolute change from Baseline to week 12 in sebum production measured at the mid-glabellar region of the forehead using a Sebumeter.
Time Frame Day 0 through day 80
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat subpopulation visiting a subset of sites with a Sebumeter.
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 19 9
Mean (Standard Deviation)
Unit of Measure: μg/cm^2
26.2  (52.48) -22.9  (34.47)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm Vehicle Control
Hide Arm/Group Description

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

All-Cause Mortality
Treatment Arm Vehicle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
Treatment Arm Vehicle Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Arm Vehicle Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/23 (17.39%)      1/13 (7.69%)    
General disorders     
Application site dryness * 1  2/23 (8.70%)  2 0/13 (0.00%)  0
Application site irritation * 1  1/23 (4.35%)  1 0/13 (0.00%)  0
Influenza like illness * 1  1/23 (4.35%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea * 1  0/23 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Acne * 1  1/23 (4.35%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA version 21.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emma Taylor, MD CEO
Organization: Naked Biome
Phone: 626-260-1230
EMail: emma.t@nakedbiome.com
Layout table for additonal information
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