A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

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.
    

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

      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.
    

Intervention name(s): NB01
Intervention type(s): Biological
Intervention description(s): Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01
Intervention model: Single Group Assignment
Intervention model description: Open label.
Masking: None (Open Label)
Primary purpose: Treatment