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

Completed · Phase 1

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID: NCT03709654
Run by: Naked Biome, Inc.
People needed: 36
Starts: 2018-11-01
Expected to finish: 2019-09-30
Last updated by the study team: 2020-08-03

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has provided written informed consent.
Subject is male or non-pregnant female, 18-40 years of age, inclusive at Screening.
Subject has moderate facial acne vulgaris
Female subject with non-cyclical acne.
Women of childbearing potential (WOCBP) willing to use adequate contraception during study participation
Male subjects willing to use an acceptable method of contraception during study participation.
Subject has the ability to personally apply benzoyl peroxide (BPO) and study drug, as per protocol.

You may not qualify if…

Subject has active bacterial, viral, or fungal skin infections.
Subject has active nodulocystic acne or acne conglobate, acne fulminans, or other forms of acne (e.g., acne mechanica).
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.
Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
Subject has a history of chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.
Subject has a history of malignancy (with the exception of non-melanoma skin cancer).
Subject is immunosuppressed (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome [AIDS], neutropenia).
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.
Subjects with close contacts (e.g., spouses, children, or members in the same household) that have severe skin barrier defects or are immunocompromised.
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

Where it is running

03 — San Diego, California, United States
01 — Arlington, Texas, United States
02 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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