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

• 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: Naked Biome, Inc.
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment Arm	Vehicle Control
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

Baseline Characteristics

Arm/Group Title		Treatment Arm	Vehicle Control	Total
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
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)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Changes in Local Skin Reactions
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

Outcome Measure Data

Analysis Population Description

The Safety population included all randomized subjects who received and applied study drug.

Arm/Group Title	Treatment Arm	Vehicle Control
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
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

Outcome Measure Data

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
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"
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

Outcome Measure Data

Analysis Population Description

modified intent-to-treat (mITT)

Arm/Group Title	Treatment Arm	Vehicle Control
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
Description	Reporting absolute change in counts.
Time Frame	Day 0 through day 80

Outcome Measure Data

Analysis Population Description

modified intent-to-treat (mITT) population

Arm/Group Title		Treatment Arm	Vehicle Control
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
Description	Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Time Frame	Day 0 through day 80

Outcome Measure Data

Analysis Population Description

modified intent-to-treat (mITT) population

Arm/Group Title		Treatment Arm	Vehicle Control
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)
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

Outcome Measure Data

Analysis Population Description

modified intent-to-treat (mITT) population

Arm/Group Title	Treatment Arm	Vehicle Control
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
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

Outcome Measure Data

Analysis Population Description

modified intent-to-treat (mITT) population

Arm/Group Title	Treatment Arm	Vehicle Control
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
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

Outcome Measure Data

Analysis Population Description

Ad Hoc Subject 02-005 (outlier) Censored mITT Population

Arm/Group Title		Treatment Arm	Vehicle Control
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
Description	Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Time Frame	Day 0 through day 80

Outcome Measure Data

Analysis Population Description

Ad Hoc Subject 02-005 Censored mITT Population

Arm/Group Title		Treatment Arm	Vehicle Control
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
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

Outcome Measure Data

Analysis Population Description

modified intent-to-treat (mITT) population

Arm/Group Title	Treatment Arm	Vehicle Control
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.
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

Outcome Measure Data

Analysis Population Description

modified intent-to-treat subpopulation visiting a subset of sites with a Sebumeter.

Arm/Group Title	Treatment Arm	Vehicle Control
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)

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment Arm		Vehicle Control
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%)
Serious Adverse Events
	Treatment Arm		Vehicle Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0.00%)		0/13 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Emma Taylor, MD CEO
• Organization: Naked Biome
• Phone: 626-260-1230
• EMail: emma.t@nakedbiome.com

Publications of Results:

Fitz-Gibbon S, Tomida S, Chiu BH, Nguyen L, Du C, Liu M, Elashoff D, Erfe MC, Loncaric A, Kim J, Modlin RL, Miller JF, Sodergren E, Craft N, Weinstock GM, Li H. Propionibacterium acnes strain populations in the human skin microbiome associated with acne. J Invest Dermatol. 2013 Sep;133(9):2152-60. doi: 10.1038/jid.2013.21. Epub 2013 Jan 21.

Johnson T, Kang D, Barnard E, Li H. Strain-Level Differences in Porphyrin Production and Regulation in Propionibacterium acnes Elucidate Disease Associations. mSphere. 2016 Feb 10;1(1):e00023-15. doi: 10.1128/mSphere.00023-15. eCollection 2016 Jan-Feb.

McDowell A, Barnard E, Nagy I, Gao A, Tomida S, Li H, Eady A, Cove J, Nord CE, Patrick S. An expanded multilocus sequence typing scheme for propionibacterium acnes: investigation of 'pathogenic', 'commensal' and antibiotic resistant strains. PLoS One. 2012;7(7):e41480. doi: 10.1371/journal.pone.0041480. Epub 2012 Jul 30.

Tomida S, Nguyen L, Chiu BH, Liu J, Sodergren E, Weinstock GM, Li H. Pan-genome and comparative genome analyses of propionibacterium acnes reveal its genomic diversity in the healthy and diseased human skin microbiome. mBio. 2013 Apr 30;4(3):e00003-13. doi: 10.1128/mBio.00003-13.

• 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