A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: NB01; Vehicle Control
Intervention description: 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; 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double Blind Vehicle Controlled Trial, dual arm with 2:1 treatment to vehicle assignment
Masking: Double (Participant, Investigator)
Masking description: Double blind
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: acne; pimple; black head; white head; zit; probiotic

Summary:

      Acne vulgaris is a disease caused my multiple factors including overgrowth of bacteria,
      clogged pores, excessive sebum production and hormonal changes. Recent literature from the
      Human Microbiome Project has shown there are bacterial strains specific to healthy and acne
      disease states (Fitz-Gibbon et al, 2013, Johnson et al, 2016, McDowell et al, 2012, Tomida et
      al, 2013)

      From this data, the investigators hypothesize that by eliminating disease-associated
      bacterial strains and replacing them with health-associated strains, recurrences or flares 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 multiple application study evaluating the
      safety, tolerability, and clinical impact that a multiple applications of NB01 have on adult
      subjects with moderate acne.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has provided written informed consent.

          2. Subject is male or non-pregnant female, 18-40 years of age, inclusive at Screening.

          3. Subject has moderate facial acne vulgaris

          4. Female subject with non-cyclical acne.

          5. Women of childbearing potential (WOCBP) willing to use adequate contraception during
             study participation

          6. Male subjects willing to use an acceptable method of contraception during study
             participation.

          7. Subject has the ability to personally apply benzoyl peroxide (BPO) and study drug, as
             per protocol.

        Exclusion Criteria:

          1. Subject has active bacterial, viral, or fungal skin infections.

          2. Subject has active nodulocystic acne or acne conglobate, acne fulminans, or other
             forms of acne (e.g., acne mechanica).

          3. Subject is currently participating in an investigational drug, device, or biologic
             study or has used an investigational drug, biologic or device treatment within 30 days
             prior to first application of the study drug.

          4. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other
             foreign or prosthetic devices/implantable devices/hardware.

          5. Subject has a history of chronic human immunodeficiency virus (HIV), hepatitis C virus
             (HCV), or hepatitis B virus (HBV) infections.

          6. Subject has a history of malignancy (with the exception of non-melanoma skin cancer).

          7. Subject is immunosuppressed (such as resulting from transplantation, immunosuppressive
             therapy, active HIV infection/acquired immune deficiency syndrome [AIDS],
             neutropenia).

          8. Subject had a 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.

          9. Subjects with close contacts (e.g., spouses, children, or members in the same
             household) that have severe skin barrier defects or are immunocompromised.

         10. Female subject is pregnant or lactating or is planning to become pregnant and/or
             breast feed within the duration of study participation.

        Other entry criteria not listed above will be reviewed of each prospective subject by the
        study staff to confirm eligibility