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

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.
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 1B Study of the Safety,
      Short-Term Engraftment and Action of 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
      (NB01) to restore the skin to a healthy state via this replacement therapy.

      The investigators aim to test this in a Phase 1B multiple application study evaluating the
      safety, tolerability, and clinical impact that a multiple, daily, applications 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 and tolerability of a multiple application of topical P. acnes
      microbiome transplant ("NB01").

      Exploratory Objectives:

        1. To define engraftment duration of NB01.

        2. To evaluate preliminary clinical efficacy using Acne Lesion Counts (total, inflammatory,
           and non-inflammatory), Investigator Global Assessment (IGA), and subjective improvement
           of acne based on subject reported outcomes (Acne QoL Questionnaire).

        3. To evaluate treatment effects, based on sebum production in a subpopulation from sites
           02 and 03.

      Approximately 36 total male and female adult subjects combined with moderate, non-cyclical
      acne will be enrolled into the trial. Approximately twenty four (24) subjects will be
      randomly assigned treatment and twelve (12) subjects will be randomly assigned to vehicle
      control.

      This is a multiple topical application study of live bacteria for the study of acne in adult
      subjects. Following a 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill
      resident facial bacterial, 11 weeks of daily topical application of NB01 will be evaluated.

      Subject participation in the trial will approximately 12 weeks.
    

Intervention name(s): NB01; Vehicle Control
Intervention type(s): Biological; Other
Intervention description(s): 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
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)
Primary purpose: Treatment
Keywords: acne; pimple; black head; white head; zit; probiotic