ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Safety, Engraftment, and Action of 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: NCT03450369
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
Dermatology Research Institute
QST Consultations
Science 37
Information provided by (Responsible Party):
Naked Biome, Inc.

Brief Summary:

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 has on adult subjects with moderate acne.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Biological: NB01 Phase 1

Detailed Description:

A Phase IB 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 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:

  1. To determine the safety profile and tolerability of a singly applied NB01
  2. To define engraftment of a singly applied topical NB01.
  3. 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IB Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly-Applied NB01 in Adults With Moderate Acne
Actual Study Start Date : January 24, 2018
Actual Primary Completion Date : June 18, 2018
Actual Study Completion Date : June 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: NB01
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.
Biological: NB01
Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01




Primary Outcome Measures :
  1. Subject engraftment with a singly applied NB01 using proprietary qPCR assays that detect the relative percentages of health-associated (NB01) and disease-associated bacteria to total bacteria recovered. [ Time Frame: 3 Month ]
    Engraftment is defined as the percentage of bacteria recovered that are health-associated (NB01) compared to total bacteria recovered. Successful engraftment is defined as detecting >40% of bacteria recovered as health-associated post application.

  2. Dose schedule determination based on the duration of engraftment of a singly applied NB01 [ Time Frame: 3 Month ]
    Dose schedule is determined based on duration of engraftment of a single application of NB01. Example, if NB01 is detected for less than 12 hours, then a reasonable dose schedule would be BID dosing. In contrast, if it is detected for 24 hours, then a reasonable dose would be daily.

  3. Safety profile and tolerability of a singly applied NB01 using the Investigator Global Assessment (IGA) 5-Point Score, with higher scores representing worsening or more severe acne [ Time Frame: 3 months ]

    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)


  4. Safety profile and tolerability of a singly applied NB01 using acne lesion counts, with higher numbers of lesion representing worsening or more severe acne [ Time Frame: 3 months ]

    Acne lesion counts are a standard FDA acne assessment tool with scoring as follows:

    Mild acne

    • <20 comedones
    • <15 inflammatory lesions
    • Or, total lesion count <30

    Moderate acne

    • 20-100 comedones
    • 15-50 inflammatory lesions
    • Or, total lesion count 30-125

    Severe acne

    • >5 pseudocysts
    • Total comedone count >100
    • Total inflammatory count >50
    • Or, total lesion count >125

  5. 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 [ Time Frame: 3 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.

  6. 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 [ Time Frame: 3 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.

  7. 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 [ Time Frame: 3 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.

  8. 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 [ Time Frame: 3 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.

  9. 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 [ Time Frame: 3 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.

  10. 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 [ Time Frame: 3 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.

  11. 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. [ Time Frame: 3 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.

  12. 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. [ Time Frame: 3 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.


Secondary Outcome Measures :
  1. Clinical efficacy of a singly applied NB01 using the Investigator Global Assessment (IGA) 5-Point Score, with lower scores representing improvement or less severe acne [ Time Frame: 3 months ]

    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.).

    Grade 1-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)


  2. Clinical efficacy of a singly applied NB01 using acne lesion counts, with lower numbers demonstrating an improvement or less severe acne [ Time Frame: 3 months ]

    Acne lesion counts are a standard FDA acne assessment tool with scoring as follows:

    Mild acne

    • <20 comedones
    • <15 inflammatory lesions
    • Or, total lesion count <30

    Moderate acne

    • 20-100 comedones
    • 15-50 inflammatory lesions
    • Or, total lesion count 30-125

    Severe acne

    • >5 pseudocysts
    • Total comedone count >100
    • Total inflammatory count >50
    • Or, total lesion count >125



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to provide written informed e-consent.
  2. Males and Females ages 18-40.
  3. 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).
  4. 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).
  5. 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).
  6. Females with non-cyclical acne.
  7. 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.
  8. 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.

Exclusion Criteria:

  1. Active bacterial, viral, or fungal skin infections.
  2. 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.
  3. Comorbid skin conditions in the area of application.
  4. Active periodontal disease or ongoing procedures (e.g., gum grafting).
  5. History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts.
  6. History of sarcoidosis.
  7. History septic joints/endocarditis.
  8. Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
  9. Sensitivity to or difficulty tolerating glycerin, polyethylene glycol.
  10. History of isotretinoin use, with the exception of sub-therapeutic treatment within 8 weeks of enrollment.
  11. Less than 80% compliance with BPO, or less than 5 days' worth of BPO pre-treatment (whichever is greater) during the Screening period.
  12. Current major systemic comorbid conditions.
  13. Currently participating in (or within 8 weeks of enrollment) another acne trial or other investigational drug.
  14. Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
  15. 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.
  16. Known chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.
  17. History of malignancy (with the exception of non-melanoma skin cancer).
  18. Immunosuppression (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome [AIDS], neutropenia).
  19. 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.
  20. 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.
  21. Participants with close contacts (e.g., spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised.
  22. Inability or unwillingness of participant to comply with study protocol procedures.
  23. Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation.
  24. Imprisonment or under legal guardianship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450369


Locations
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Sponsors and Collaborators
Naked Biome, Inc.
Dermatology Research Institute
QST Consultations
Science 37
Investigators
Study Director: Emma Taylor, MD CEO

Additional Information:
Publications:

Responsible Party: Naked Biome, Inc.
ClinicalTrials.gov Identifier: NCT03450369     History of Changes
Other Study ID Numbers: NB01-P1BSA
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Initially there is no plan to share IPD. This may change later as the clinical plan develops.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases