Phase 1 N=10 Treatment

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

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT03450369 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Number of Participants With Successful Engraftment of Probiotic Following a Single Application. — 2; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: NB01 (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Naked Biome, Inc.
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Successful Engraftment of Probiotic Following a Single Application.	2; 1	—
PRIMARY Dose Schedule Determination Based on Time to Peak deoR and Cas5	-0.4; 51.2; -4.2; 5.2; 13.8; 2.8	—
PRIMARY Number of Participants With Change in Investigator Global Assessment (IGA) Score	0; 0; 0; 0; 0; 0	—
PRIMARY Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.	49.4; 38.8; 22.6; 42.6; 21.0; 39.8	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling	3; 5; 2; 0; 4; 5	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis	5; 5; 5; 5; 5; 5	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation	5; 5; 5; 5; 5; 5	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation	5; 5; 5; 5; 5; 5	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection	5; 5; 5; 5; 5; 5	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity	5; 5; 5; 5; 5; 5	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.	2; 5; 3; 0; 3; 5	—
PRIMARY Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.	4; 5; 1; 0; 4; 5	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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 t

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Data sourced from ClinicalTrials.gov (NCT03450369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.