Acne VulgarisPhase 1NCT03450369

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

A Phase 1 study testing NB01 in people with Acne Vulgaris, run by Naked Biome, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Acne Vulgaris
What is being tested?: NB01
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2018to 18 Jun 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Ability to provide written informed e-consent.
Males and Females ages 18-40.
Acne severity: Moderate (Grade 3 on 5-point IGA scale and Moderate on an acne lesion count scale (Appendix B [Section 12.2], IGA and Lesion Count Acne Grading).
Acne treatment-free period (including topical or oral antibiotics, retinoids, laser therapy, topical dapsone, topical azelaic acid, facial peels, dermabrasion, sulfacetamide sulfur, and salicylic acid), of at least 3 weeks prior to e-consent (with the exception of BPO pre-treatment under this protocol).
Lesion count: A minimum of at least a total of 15 inflammatory lesions (papules plus pustules), with a minimum of 10 inflammatory lesions within the designated application area (cheek/nose).
Females with non-cyclical acne.
Females of childbearing potential willing to use adequate contraception (e.g., total abstinence, intrauterine device (IUD), barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera®, Norplant®, or NuvaRing® for the duration of the Screening Period and during study participation. All oral contraceptive and hormonal implants will need to have been initiated and on a stable dose for at least 3 months prior to the screening period. Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal; postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Male participants willing to use an acceptable method of contraception (e.g., total abstinence, barrier methods with spermicide, surgical sterilization or surgically sterilized partner) during study participation.

Who cannot join

Active bacterial, viral, or fungal skin infections.
Any noticeable breaks or cracks in the skin on the face, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
Comorbid skin conditions in the area of application.
Active periodontal disease or ongoing procedures (e.g., gum grafting).
History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts.
History of sarcoidosis.

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History septic joints/endocarditis.
Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
Sensitivity to or difficulty tolerating glycerin, polyethylene glycol.
History of isotretinoin use, with the exception of sub-therapeutic treatment within 8 weeks of enrollment.
Less than 80% compliance with BPO, or less than 5 days' worth of BPO pre-treatment (whichever is greater) during the Screening period.
Current major systemic comorbid conditions.
Currently participating in (or within 8 weeks of enrollment) another acne trial or other investigational drug.
Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
Participants with close contact (e.g., spouses, children, or members in the same household) with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
Known chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.
History of malignancy (with the exception of non-melanoma skin cancer).
Immunosuppression (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome [AIDS], neutropenia).
Major surgical procedure, open biopsy, or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed), or anticipation of the need for major surgery during the study.
The presence of a medical or psychiatric condition, history of drug or alcohol abuse that, in the opinion of the PI, makes the subject inappropriate for study inclusion.
Participants with close contacts (e.g., spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised.
Inability or unwillingness of participant to comply with study protocol procedures.
Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation.
Imprisonment or under legal guardianship.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dermatology Research Associates
Los Angeles, California, 90045

Other trials in United States

About this study

Official title: A Phase 1B Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly-Applied NB01 in Adults With Moderate Acne

Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to healthy and acne disease states.

From this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy.

The investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01, a live strain of P. acnes, has on adult subjects with moderate acne.

Read the detailed description

A Phase 1B Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly Applied NB01 in Adults with Moderate Acne

The investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01 has on adult subjects with moderate acne. Investigators will be profiling the change in microbiome over the course of therapy to determine if exogenously delivered bacteria can populate the skin (engraftment) and cause a shift in the microbiome safely and subsequently impact acne biomarkers that may correlate with clinical disease.

The investigators intend for this therapy to eventually be used in acne subjects with ages ranging from 13-40, and all disease severities as either monotherapy for mild to mild/moderate acne and as an adjuvant therapy for moderate to severe acne at all body sites, with special attention to facial involvement.

This approach is standard to acne therapy whereby mild disease will be treated with a monotherapy (i.e., topical Benzoyl peroxide [BPO]) and moderate/severe disease will be treated with various combinatory regimens (topical antibiotics, BPO, topical retinoids, oral antibiotics).

Primary Objectives:

To determine the safety profile and tolerability of a singly applied NB01
To define engraftment of a singly applied topical NB01.
Dose schedule determination based on engraftment

Secondary Objective: To evaluate clinical efficacy using FDA standards of acne clinical assessments, namely the Investigator Global Assessment (IGA) and acne lesion counts of a singly applied NB01.

Approximately 10 total male and female adult subjects combined with moderate, non-cyclical acne will be enrolled into the trial. Approximately five (5) subjects will be assigned to each dose schedule

This is a single topical application study of live bacteria for the study of acne in adult subjects.

Subject participation in the trial will range from 5 weeks to 2 months.

Conditions: Acne Vulgaris
Being tested: NB01
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NB01Biological
Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01

Study groups in NCT03450369
Study group	Role	What they receive
NB01	Experimental	NB01 is a live probiotic containing a single strain of P. acnes, frozen, on a pad, in a single use pouch, for topical application. Open label and dose escalation of a single application of NB01 to subjects with moderate acne, with approximately 5 subjects assigned to lower bound dose before escalation to upper bound dose. Receives: Biological: NB01

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Successful Engraftment of Probiotic Following a Single Application.
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.
Measured: 2 Months
Dose Schedule Determination Based on Time to Peak deoR and Cas5
To 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.
Measured: From Baseline to 48 hours after application
Number of Participants With Change in Investigator Global Assessment (IGA) Score
Number 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)
Measured: 28 Days
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Absolute Lesion Count: All Lesions for the Whole Face; with higher numbers of lesion representing worsening or more severe acne
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
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.
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
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.
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
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.
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
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.
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
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.
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
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.
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
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.
Measured: From Screening to 28 days after application, typically 2 months
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
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.
Measured: From Screening to 28 days after application, typically 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 201818 Jun 2018

First posted1 Mar 2018
Study start24 Jan 2018
Primary completion18 Jun 2018
Study completion18 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open label.
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03450369
Sponsor's protocol ID: NB01-P1BSA
Status last verified: Jul 2020
First submitted: 13 Feb 2018
Last updated: 3 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Initially there is no plan to share individual participant data (IPD). This may change later as the clinical plan develops.

Publications

Achermann Y, Goldstein EJ, Coenye T, Shirtliff ME. Propionibacterium acnes: from commensal to opportunistic biofilm-associated implant pathogen. Clin Microbiol Rev. 2014 Jul;27(3):419-40. doi: 10.1128/CMR.00092-13.
PubMed 24982315
Akaza N, Akamatsu H, Numata S, Yamada S, Yagami A, Nakata S, Matsunaga K. Microorganisms inhabiting follicular contents of facial acne are not only Propionibacterium but also Malassezia spp. J Dermatol. 2016 Aug;43(8):906-11. doi: 10.1111/1346-8138.13245. Epub 2015 Dec 24.
PubMed 26705192
Baquerizo Nole KL, Yim E, Keri JE. Probiotics and prebiotics in dermatology. J Am Acad Dermatol. 2014 Oct;71(4):814-21. doi: 10.1016/j.jaad.2014.04.050. Epub 2014 Jun 4.
PubMed 24906613
Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.
PubMed 19892944
Dailey HA, Gerdes S, Dailey TA, Burch JS, Phillips JD. Noncanonical coproporphyrin-dependent bacterial heme biosynthesis pathway that does not use protoporphyrin. Proc Natl Acad Sci U S A. 2015 Feb 17;112(7):2210-5. doi: 10.1073/pnas.1416285112. Epub 2015 Feb 2.
PubMed 25646457
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.
PubMed 23337890
Gribbon EM, Cunliffe WJ, Holland KT. Interaction of Propionibacterium acnes with skin lipids in vitro. J Gen Microbiol. 1993 Aug;139(8):1745-51. doi: 10.1099/00221287-139-8-1745.
PubMed 8409917
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.
PubMed 27303708
Kang D, Shi B, Erfe MC, Craft N, Li H. Vitamin B12 modulates the transcriptome of the skin microbiota in acne pathogenesis. Sci Transl Med. 2015 Jun 24;7(293):293ra103. doi: 10.1126/scitranslmed.aab2009.
PubMed 26109103
Kasimatis G, Fitz-Gibbon S, Tomida S, Wong M, Li H. Analysis of complete genomes of Propionibacterium acnes reveals a novel plasmid and increased pseudogenes in an acne associated strain. Biomed Res Int. 2013;2013:918320. doi: 10.1155/2013/918320. Epub 2013 May 13.
PubMed 23762865
Kishishita M, Ushijima T, Ozaki Y, Ito Y. New medium for isolating propionibacteria and its application to assay of normal flora of human facial skin. Appl Environ Microbiol. 1980 Dec;40(6):1100-5. doi: 10.1128/aem.40.6.1100-1105.1980.
PubMed 7470244
Kjeldstad B, Johnsson A, Sandberg S. Influence of pH on porphyrin production in Propionibacterium acnes. Arch Dermatol Res. 1984;276(6):396-400. doi: 10.1007/BF00413361.
PubMed 6517611
Kwon HH, Suh DH. Recent progress in the research about Propionibacterium acnes strain diversity and acne: pathogen or bystander? Int J Dermatol. 2016 Nov;55(11):1196-1204. doi: 10.1111/ijd.13282.
PubMed 27421121
Lomholt HB, Kilian M. Population genetic analysis of Propionibacterium acnes identifies a subpopulation and epidemic clones associated with acne. PLoS One. 2010 Aug 19;5(8):e12277. doi: 10.1371/journal.pone.0012277.
PubMed 20808860
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.
PubMed 22859988

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1B Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly-Applied NB01 in Adults With Moderate Acne
ClinicalTrials.gov ID: NCT03450369
Acronym / sponsor ID: NB01-P1BSA
Conditions: Acne Vulgaris
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Naked Biome, Inc.Industry (pharma, biotech, devices)
Collaborators: Dermatology Research Institute, QST Consultations, Ltd., Science 37
Study start: 24 Jan 2018 (actual)
Primary completion: 18 Jun 2018 (actual)
Study completion: 18 Jun 2018 (actual)
First posted: 1 Mar 2018 (actual)
Results: Posted 3 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A Phase 1B Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly Applied NB01 in Adults with Moderate Acne

Primary Objectives:

To determine the safety profile and tolerability of a singly applied NB01
To define engraftment of a singly applied topical NB01.
Dose schedule determination based on engraftment

Secondary Objective: To evaluate clinical efficacy using FDA standards of acne clinical assessments, namely the Investigator Global Assessment (IGA) and acne lesion counts of a singly applied NB01.

Approximately 10 total male and female adult subjects combined with moderate, non-cyclical acne will be enrolled into the trial. Approximately five (5) subjects will be assigned to each dose schedule

This is a single topical application study of live bacteria for the study of acne in adult subjects.

Subject participation in the trial will range from 5 weeks to 2 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label.

Arm	Type	Receives
NB01	Experimental	Biological: NB01NB01 is a live probiotic containing a single strain of P. acnes, frozen, on a pad, in a single use pouch, for topical application. Open label and dose escalation of a single application of NB01 to subjects with moderate acne, with approximately 5 subjects assigned to lower bound dose before escalation to upper bound dose.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Ability to provide written informed e-consent.
Males and Females ages 18-40.
Acne severity: Moderate (Grade 3 on 5-point IGA scale and Moderate on an acne lesion count scale (Appendix B [Section 12.2], IGA and Lesion Count Acne Grading).
Acne treatment-free period (including topical or oral antibiotics, retinoids, laser therapy, topical dapsone, topical azelaic acid, facial peels, dermabrasion, sulfacetamide sulfur, and salicylic acid), of at least 3 weeks prior to e-consent (with the exception of BPO pre-treatment under this protocol).
Lesion count: A minimum of at least a total of 15 inflammatory lesions (papules plus pustules), with a minimum of 10 inflammatory lesions within the designated application area (cheek/nose).

Key exclusion criteria (24 listed)

Active bacterial, viral, or fungal skin infections.
Any noticeable breaks or cracks in the skin on the face, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
Comorbid skin conditions in the area of application.
Active periodontal disease or ongoing procedures (e.g., gum grafting).
History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NB01Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01	Biological	NB01

Primary outcome

Number of Participants With Successful Engraftment of Probiotic Following a Single Application.
Time frame: 2 Months
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.
Dose Schedule Determination Based on Time to Peak deoR and Cas5
Time frame: From Baseline to 48 hours after application
To 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.
Number of Participants With Change in Investigator Global Assessment (IGA) Score
Time frame: 28 Days
Number 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)
Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.
Time frame: From Screening to 28 days after application, typically 2 months
Absolute Lesion Count: All Lesions for the Whole Face; with higher numbers of lesion representing worsening or more severe acne
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling
Time frame: From Screening to 28 days after application, typically 2 months
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.
Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis
Time frame: From Screening to 28 days after application, typically 2 months
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.
Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation
Time frame: From Screening to 28 days after application, typically 2 months
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.
Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation
Time frame: From Screening to 28 days after application, typically 2 months
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.
Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection
Time frame: From Screening to 28 days after application, typically 2 months
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.
Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity
Time frame: From Screening to 28 days after application, typically 2 months
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.
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.
Time frame: From Screening to 28 days after application, typically 2 months
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.
Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.
Time frame: From Screening to 28 days after application, typically 2 months
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.

Results and safety

Results posted to the registry on 3 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose	5	5
High Dose	5	5

Primary outcome: Number of Participants With Successful Engraftment of Probiotic Following a Single Application.

Time frame: 2 Months. Count of participants. Unit: Participants

Measure	Low Dose n = 5	High Dose n = 5
Value	2	1

Primary outcome: Dose Schedule Determination Based on Time to Peak deoR and Cas5

Time frame: From Baseline to 48 hours after application. Mean (Standard Deviation). Unit: % of total bacteria w/ genotype

Measure	Low Dose n = 5	High Dose n = 5
Genotype 1 (deoR), 6 hours	-0.4 (36.3)	51.2 (28.6)
Genotype 1 (deoR), 24 hours	-4.2 (25.7)	5.2 (7.6)
Genotype 1 (deoR), 48 hours	13.8 (33.5)	2.8 (10.9)
Genotype 2 (Cas 5), 6 hours	12.8 (27.9)	48.4 (21.7)
Genotype 2 (Cas 5), 24 hours	3.4 (15.6)	4.4 (8.8)
Genotype 2 (Cas 5), 48 hours	3.2 (12.2)	1.8 (12.1)

Primary outcome: Number of Participants With Change in Investigator Global Assessment (IGA) Score

Time frame: 28 Days. Count of participants. Unit: Participants

Measure	Low Dose n = 5	High Dose n = 5
Participants with changed IGA @ 6 hours	0	0
Participants with changed IGA @ 1 day	0	0
Participants with changed IGA @ 2 days	0	0
Participants with changed IGA @ 6 days	0	0
Participants with changed IGA @ 28 days	2	0

Primary outcome: Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.

Time frame: From Screening to 28 days after application, typically 2 months. Mean (Standard Deviation). Unit: count of lesions

Measure	Low Dose n = 5	High Dose n = 5
Screening	49.4 (21.08)	38.8 (16.60)
Day 1 (0 hours)	22.6 (13.26)	42.6 (3.8)
Day 1 (6 hours)	21.0 (9.22)	39.8 (25.41)
Day 2	31.6 (3.51)	38.2 (25.29)
Day 3	32.2 (6.18)	35.4 (24.17)
Day 7	25.6 (4.72)	34.2 (19.11)
Day 28	25.8 (14.31)	32.6 (59.22)

Population analysed: All participants who received at least one dose of treatment.

Adverse events

Time frame: From Screening to 28 days after application, typically 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose	0 of 5 (0%)	1 of 5 (20%)	0 of 5
High Dose	0 of 5 (0%)	1 of 5 (20%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24982315Achermann Y, Goldstein EJ, Coenye T, Shirtliff ME. Propionibacterium acnes: from commensal to opportunistic biofilm-associated implant pathogen. Clin Microbiol Rev. 2014 Jul;27(3):419-40. doi: 10.1128/CMR.00092-13.
Background: PubMed 26705192Akaza N, Akamatsu H, Numata S, Yamada S, Yagami A, Nakata S, Matsunaga K. Microorganisms inhabiting follicular contents of facial acne are not only Propionibacterium but also Malassezia spp. J Dermatol. 2016 Aug;43(8):906-11. doi: 10.1111/1346-8138.13245. Epub 2015 Dec 24.
Background: PubMed 24906613Baquerizo Nole KL, Yim E, Keri JE. Probiotics and prebiotics in dermatology. J Am Acad Dermatol. 2014 Oct;71(4):814-21. doi: 10.1016/j.jaad.2014.04.050. Epub 2014 Jun 4.
Background: PubMed 19892944Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.
Background: PubMed 25646457Dailey HA, Gerdes S, Dailey TA, Burch JS, Phillips JD. Noncanonical coproporphyrin-dependent bacterial heme biosynthesis pathway that does not use protoporphyrin. Proc Natl Acad Sci U S A. 2015 Feb 17;112(7):2210-5. doi: 10.1073/pnas.1416285112. Epub 2015 Feb 2.
Background: PubMed 23337890Fitz-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.
Background: PubMed 8409917Gribbon EM, Cunliffe WJ, Holland KT. Interaction of Propionibacterium acnes with skin lipids in vitro. J Gen Microbiol. 1993 Aug;139(8):1745-51. doi: 10.1099/00221287-139-8-1745.
Background: PubMed 27303708Johnson 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.
Background: PubMed 26109103Kang D, Shi B, Erfe MC, Craft N, Li H. Vitamin B12 modulates the transcriptome of the skin microbiota in acne pathogenesis. Sci Transl Med. 2015 Jun 24;7(293):293ra103. doi: 10.1126/scitranslmed.aab2009.
Background: PubMed 23762865Kasimatis G, Fitz-Gibbon S, Tomida S, Wong M, Li H. Analysis of complete genomes of Propionibacterium acnes reveals a novel plasmid and increased pseudogenes in an acne associated strain. Biomed Res Int. 2013;2013:918320. doi: 10.1155/2013/918320. Epub 2013 May 13.
Background: PubMed 7470244Kishishita M, Ushijima T, Ozaki Y, Ito Y. New medium for isolating propionibacteria and its application to assay of normal flora of human facial skin. Appl Environ Microbiol. 1980 Dec;40(6):1100-5. doi: 10.1128/aem.40.6.1100-1105.1980.
Background: PubMed 6517611Kjeldstad B, Johnsson A, Sandberg S. Influence of pH on porphyrin production in Propionibacterium acnes. Arch Dermatol Res. 1984;276(6):396-400. doi: 10.1007/BF00413361.
\[ClinicalTrials.gov\] Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne. Received: August 2009; Updated: October 2016.Link provided by the sponsor.
DermNet New Zealand. Acne vulgaris: Acne GradingLink provided by the sponsor.
\[FDA\] Guidance for Industry: Acne Vulgaris: Developing Drugs for Treatment. Draft: September 2005Link provided by the sponsor.
Investigator Assessment Tolerability Scoring. A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne, 2009; updated 2016Link provided by the sponsor.
Propionibacterium acnes e a resistência bacteriana \[Propionibacterium acnes and bacterial resistance\]Link provided by the sponsor.
Propionibacteriales ord. Nov. In: Whitman W, et al. eds. Bergey's Manual of Systematic BacteriologyLink provided by the sponsor.
Individual participant dataSharing planned: No. Initially there is no plan to share individual participant data (IPD). This may change later as the clinical plan develops.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emma Taylor, MD study director

CEO

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NB01 in people with Acne Vulgaris, run by Naked Biome, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Successful Engraftment of Probiotic Following a Single Application. (time frame: 2 Months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03450369, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.