A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: NB01
Intervention description: Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label.
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

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, a live strain of
      P. acnes, has on adult subjects with moderate acne.
    

Eligibility 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.