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

Completed · Phase 1

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID: NCT03450369
Run by: Naked Biome, Inc.
People needed: 10
Starts: 2018-01-24
Expected to finish: 2018-06-18
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…

Ability to provide written informed e-consent.
Males and Females ages 18-40.
Acne severity: Moderate (Grade 3 on 5-point IGA scale and Moderate on an acne lesion count scale (Appendix B [Section 12.2], IGA and Lesion Count Acne Grading).
Acne treatment-free period (including topical or oral antibiotics, retinoids, laser therapy, topical dapsone, topical azelaic acid, facial peels, dermabrasion, sulfacetamide sulfur, and salicylic acid), of at least 3 weeks prior to e-consent (with the exception of BPO pre-treatment under this protocol).
Lesion count: A minimum of at least a total of 15 inflammatory lesions (papules plus pustules), with a minimum of 10 inflammatory lesions within the designated application area (cheek/nose).
Females with non-cyclical acne.
Females of childbearing potential willing to use adequate contraception (e.g., total abstinence, intrauterine device (IUD), barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera®, Norplant®, or NuvaRing® for the duration of the Screening Period and during study participation. All oral contraceptive and hormonal implants will need to have been initiated and on a stable dose for at least 3 months prior to the screening period. Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal; postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Male participants willing to use an acceptable method of contraception (e.g., total abstinence, barrier methods with spermicide, surgical sterilization or surgically sterilized partner) during study participation.

You may not qualify if…

Active bacterial, viral, or fungal skin infections.
Any noticeable breaks or cracks in the skin on the face, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
Comorbid skin conditions in the area of application.
Active periodontal disease or ongoing procedures (e.g., gum grafting).
History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts.
History of sarcoidosis.
History septic joints/endocarditis.
Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
Sensitivity to or difficulty tolerating glycerin, polyethylene glycol.
History of isotretinoin use, with the exception of sub-therapeutic treatment within 8 weeks of enrollment.
Less than 80% compliance with BPO, or less than 5 days' worth of BPO pre-treatment (whichever is greater) during the Screening period.
Current major systemic comorbid conditions.
Currently participating in (or within 8 weeks of enrollment) another acne trial or other investigational drug.
Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
Participants with close contact (e.g., spouses, children, or members in the same household) with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
Known chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.
History of malignancy (with the exception of non-melanoma skin cancer).
Immunosuppression (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome [AIDS], neutropenia).
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.
The presence of a medical or psychiatric condition, history of drug or alcohol abuse that, in the opinion of the PI, makes the subject inappropriate for study inclusion.
Participants with close contacts (e.g., spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised.
Inability or unwillingness of participant to comply with study protocol procedures.
Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation.
Imprisonment or under legal guardianship.

Where it is running

Dermatology Research Associates — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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