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A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne

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ClinicalTrials.gov Identifier: NCT03709654
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Therapeutics, Inc.
Information provided by (Responsible Party):
Naked Biome, Inc.

Brief 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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Treatment Arm
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
Biological: 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 NB01

Placebo Comparator: Vehicle Control
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Other: Vehicle Control
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




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Day 0 through day 80 ]
    AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported.

  2. Local Skin Reactions [ Time Frame: Day 0 through day 80 ]
    Local Skin Reactions (LSRs) including Erythema, edema, erosion/ulceration, scaling/dryness, and scabbing/crusting scored by frequency and severity at every visit.

  3. Follicular Engraftment "Success" [ Time Frame: Day 0 through day 80 ]

    Follicular engraftment sampling will be completed via use of Biore® Strips at baseline and day 80 (end of treatment).

    Engraftment "Success" Endpoint: The proportion of subjects with "success" at EOT where "success" is defined as a Follicular Biore® sample with "yes" outcome based on recovery of live NB01at day 80


  4. Skin surface engraftment "Success" [ Time Frame: Day 0 through day 80 ]

    Skin surface engraftment sampling will be completed via cheek swab at each visit.

    Skin surface engraftment "success" endpoint is defined by a percent change in TaqMan markers compared to Baseline


  5. Absolute change from baseline in Acne Lesion Counts (total, inflammatory, and non-inflammatory) [ Time Frame: Day 0 through day 80 ]
    Efficacy endpoint: Absolute change from Baseline lesion counts at Day 80 (end of treatment)

  6. Percent change from baseline in Acne Lesion Counts (total, inflammatory, and non-inflammatory). [ Time Frame: Day 0 through day 80 ]
    Efficacy endpoint: Percent change from Baseline lesion counts at Day 80 (end of treatment)

  7. Investigator Global Assessment (IGA) [ Time Frame: Day 0 through day 80 ]
    Proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.

  8. Acne QoL Questionnaire [ Time Frame: Day 0 through day 80 ]

    At each visit, subjects will be asked to complete the Acne QoL Questionnaire to assess subjective improvement of acne with 7 response choices ranging from extremely to not at all.

    Efficacy Endpoint: Absolute change from Baseline in Acne QoL to Day 80 end of treatment visit.



Other Outcome Measures:
  1. Absolute change in sebum production. [ Time Frame: Day 0 through day 80 ]
    Exploratory Endpoint: Absolute and percent change from Baseline in sebum production



Information from the National Library of Medicine

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


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): NCT03709654


Contacts
Contact: Emma Taylor, MD emma.t@nakedbiome.com
Contact: TI Clinical Research 858-571-1800 ext 105 clinicalresearch@therapeuticsinc.com

Locations
United States, Texas
01 Not yet recruiting
Arlington, Texas, United States, 76011
Contact    817-795-7546    acderm@acderm.com   
Principal Investigator: Moore, MD         
02 Not yet recruiting
Austin, Texas, United States, 78759
Contact    512-349-9889    rebecca@driresearchsite.com   
Principal Investigator: DuBois, MD         
Sponsors and Collaborators
Naked Biome, Inc.
Therapeutics, Inc.
Investigators
Study Director: Emma Taylor, MD Naked Biome

Additional Information:
Publications of Results:
Responsible Party: Naked Biome, Inc.
ClinicalTrials.gov Identifier: NCT03709654     History of Changes
Other Study ID Numbers: NB01-P1BMA
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: November 14, 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

Keywords provided by Naked Biome, Inc.:
acne
pimple
black head
white head
zit
probiotic

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents